A Phase 2 interventional study of Hydrocortisone (Solucortef) and Insulin pump (Medtronic) in Adrenal Insufficiency, Excess Androgen and Congenital Adrenal Hyperplasia (CAH), sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-12-22.
Sponsored by National Institutes of Health Clinical Center (CC) · Phase 2, Interventional, and Treatment
Among 23 studies testing hydrocortisone in Adrenal Insufficiency — 2 open to participants now, 2 under way, none of them phase 3. Hydrocortisone · Adrenal Insufficiency.
Among the 23 studies testing hydrocortisone in Adrenal Insufficiency, this one is the 23rd largest by enrollment, is one of 2 that started in 2013, is one of 3 in phase 2, and was the 9th registered.
136 studies on the registry are indexed under Adrenal Insufficiency; 27 are open to participants now.
Browse Adrenal Insufficiency studies →2 of the 23 studies testing hydrocortisone in Adrenal Insufficiency are open now, in 1 country. Recruiting first, the newest first:
Marianne Christina Klose · Sites in Denmark
Ages 50+
Marianne Andersen · Sites in Denmark
Ages 50+
By country, each count listing its studies:
Hydrocortisone: first FDA approval 1951 (HYDROCORTONE), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 20 Adrenal Insufficiency studies recruiting now, 7 (35%) set no upper age limit and 7 (35%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 99 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 4 · Phase 3 6 · Phase 4 8
First in 2002; this study’s year is marked. 2 started in 2013.
This study's enrollment of 8 is below the median of 44 across 71 interventional studies indexed under Adrenal Insufficiency.
Median enrollment 50 across the 23 interventional studies. Of the 17 that completed or were terminated, 7 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 23 have an industry lead sponsor. The 10 most frequent:
National Institutes of Health Clinical Center (CC) is the lead sponsor of 376 studies on the registry; 27 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
National Institutes of Health Clinical Center (CC) has 1 study filed under Adrenal Insufficiency — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 23 studies testing hydrocortisone in Adrenal Insufficiency, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Background:
Objectives:
Eligibility:
Design:
Study type: Interventional non-randomized trial
Official title: A Pilot Study Assessing the use of Continuous Subcutaneous Hydrocortisone Infusion In the Treatment of Congenital Adrenal Hyperplasia
Estimated enrollment: 8
Study Start Date: May 2013
Estimated Study Completion Date: December 2016
Sponsoring Institute: National Institute of Child Health and Human Development
\<TAB>ELIGIBILITY
Inclusion criteria
Exclusion criteria
Congenital adrenal hyperplasia (CAH) is a common genetic endocrine disorder, with 21-hydroxylase enzyme deficiency accounting for 95% of the cases. 21-hydroxylase deficiency presents with a spectrum of clinical manifestations ranging from salt-wasting and virilization of female neonates (classic CAH) to symptomatic (precocious puberty, short stature, acne) or asymptomatic hyperandrogenemia (non-classic CAH). Classic CAH is characterized by impaired cortisol and mineralocorticoid biosynthesis, which triggers adrenocorticotropic hormone (ACTH) hyper-secretion and accumulation of adrenal androgens. Glucocorticoid treatment of patients with classic CAH focuses on cortisol replacement and prevention of the ACTH-driven androgen excess. Current conventional glucocorticoid treatment regimens (short or long-acting agents dosed once, twice or thrice daily) have failed to simulate physiological cortisol secretion and suppress adrenal androgen overproduction, without supraphysiologic replacement. Short-term overtreatment with glucocorticoids can lead to iatrogenic Cushing syndrome and long-term use has been associated with the development of obesity, visceral adiposity, insulin resistance and osteoporosis. Isolated case reports have provided evidence that continuous subcutaneous hydrocortisone infusion (CSHI) can mimic physiologic cortisol release and lead to improved CAH control at doses similar to or lower than the traditional treatment. This pilot study aims to test the hypothesis that difficult-to-treat adult patients with classic CAH will have better adrenal androgen control and improved CAH and glucocorticoid-related comorbidities, when they receive near-physiologic cortisol replacement therapy via CSHI compared to conventional glucocorticoid treatment. In addition, this study will provide information on the safety and tolerability of CSHI, and will generate data that will be used in the design of future pediatric studies.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Enrolled participants with congenital adrenal hyperplasia (CAH) received continuous subcutaneous hydrocortisone (Solucortef) infusion (CSHI) via insulin pump (Medtronic) (MMT-722Na) to achieve near-physiologic cortisol replacement therapy. Participants were their own controls; participant's baseline outcomes/lab values while on conventional glucocorticoid therapy were compared to outcomes/lab values after 6 months of treatment using CSHI via insulin pump.
Drug: Hydrocortisone (Solucortef) · Device: Insulin pump (Medtronic)
Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA). Total daily hydrocortisone dose was calculated based on the patient's estimated cortisol clearance. Rates were established to achieve peak and trough concentrations within the normal circadian cortisol range.
Also known as: CSHI
Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Also known as: CSHI
Number of Patients With 17-OHP Levels Equal or Below 1,200 ng/dL at 0700
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
Time frame: At baseline
Number of Patients With 17-OH Progesterone Levels Equal or Below 1,200 ng/dL at 0700
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
Time frame: At 6 months
Participants Mean Level of 17-OHP at 0700
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
Time frame: At baseline
Participants Mean Level of 17-OHP at 0700
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
Time frame: At 6 months
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - 24 Hours
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At baseline
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - 24 Hours
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At 6 months
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Daytime (0700-1500)
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At baseline
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Daytime (0700-1500)
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At 6 months
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Midday (1500 - 2300)
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficienc. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At baseline
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Midday (1500 - 2300)
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At 6 months
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Nighttime (2300 - 0700)
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At baseline
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Nighttime (2300 - 0700)
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At 6 months
Participants Mean Level of Androstenedione at 0700
Participants Mean Level of Androstenedione at 0700.
Time frame: At baseline
Participants Mean Level of Androstenedione at 0700
Participants Mean Level of Androstenedione at 0700.
Time frame: At 6 months
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 Hours
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At baseline
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 Hours
Participants Mean Level of Androstenedione area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At 6 months
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500)
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At baseline
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500)
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At 6 months
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300)
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At baseline
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300)
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At 6 months
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At baseline
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At 6 months
Participants Mean Level of ACTH at 0700
Participants Mean Level of ACTH at 0700.
Time frame: At baseline
Participants Mean Level of ACTH at 0700
Participants Mean Level of ACTH at 0700.
Time frame: At 6 months
Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours
Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300.Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At baseline
Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours
Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At 6 months
Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500)
Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At baseline
Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500)
Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At 6 months
Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300)
Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At baseline
Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300)
Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At 6 months
Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At baseline
Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At 6 months
Participants Mean Progesterone Levels at 0700
Participants Mean Level of Progesterone at 0700
Time frame: At baseline
Participants Mean Progesterone Level at 0700
Participants Mean Level of Progesterone at 0700
Time frame: At 6 months
Participants Mean Level of Progesterone Area Under the Curve (AUC) - 24 Hours
Participants Mean Level of Progesterone area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At baseline
Participants Mean Level of Progesterone Area Under the Curve (AUC) - 24 Hours
Participants Mean Level of Progesterone area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At 6 months
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Daytime (0700-1500)
Participants Mean Level of Progesterone area under the curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At baseline
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Daytime (0700-1500)
Participants Mean Level of Progesterone area under the curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At 6 months
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Midday (1500 - 2300)
Participants Mean Level of Progesterone area under the curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At baseline
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Midday (1500 - 2300)
Participants Mean Level of Progesterone area under the curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At 6 months
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Participants Mean Level of Progesterone area under the curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At baseline
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Participants Mean Level of Progesterone area under the curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
Time frame: At 6 months
Participant Lean Body Mass
lean body mass measured by DEXA, Hologic Discovery-A
Time frame: At baseline
Participant Lean Body Mass
lean body mass measured by DEXA, Hologic Discovery-A
Time frame: At 6 months
Eight adult patients with classic CAH due to 21-hydroxylase deficiency participated in this study. Four were recruited from a pool of 147 patients enrolled on a natural history study at the NIH natural history study (NCT00250159); 4 were recruited through advertisements.
| Milestone | Continuous Sub-Q Hydrocortisone Infusion |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
| Participants | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Number of Patients With 17-OHP Levels Equal or Below 1,200 ng/dL at 0700 | 0 |
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
| Participants | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Number of Patients With 17-OH Progesterone Levels Equal or Below 1,200 ng/dL at 0700 | 3 |
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
| ng/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of 17-OHP at 0700 | 8313 ± 2748 |
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
| ng/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of 17-OHP at 0700 | 2150 ± 531 |
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*mcg/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of 17-OHP Area Under the Curve (AUC) - 24 Hours | 98.5 ± 39.3 |
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*mcg/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of 17-OHP Area Under the Curve (AUC) - 24 Hours | 25.7 ± 9.5 |
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*mcg/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Daytime (0700-1500) | 48.6 ± 22.4 |
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*mcg/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Daytime (0700-1500) | 6.8 ± 1.8 |
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficienc. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*mcg/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Midday (1500 - 2300) | 20.5 ± 6.8 |
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*mcg/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Midday (1500 - 2300) | 7.5 ± 4.9 |
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*mcg/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Nighttime (2300 - 0700) | 29.5 ± 11.1 |
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*mcg/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Nighttime (2300 - 0700) | 11.4 ± 3.0 |
Participants Mean Level of Androstenedione at 0700.
| ng/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Androstenedione at 0700 | 748 ± 295 |
Participants Mean Level of Androstenedione at 0700.
| ng/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Androstenedione at 0700 | 317 ± 77 |
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*mcg/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 Hours | 12.7 ± 4.5 |
Participants Mean Level of Androstenedione area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*mcg/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 Hours | 5.2 ± 1.4 |
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*mcg/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500) | 5.3 ± 2.1 |
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*mcg/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500) | 1.8 ± 0.4 |
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*mcg/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300) | 3.7 ± 1.1 |
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*mcg/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300) | 1.6 ± 0.6 |
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*mcg/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700) | 3.7 ± 1.3 |
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*mcg/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700) | 1.8 ± 0.4 |
Participants Mean Level of ACTH at 0700.
| pg/mL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of ACTH at 0700 | 405 ± 114 |
Participants Mean Level of ACTH at 0700.
| pg/mL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of ACTH at 0700 | 139 ± 47 |
Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300.Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*pg/mL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours | 2538 ± 743 |
Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*pg/mL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours | 1087 ± 359 |
Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*pg/mL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500) | 1239 ± 402 |
Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*pg/mL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500) | 340 ± 107 |
Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*pg/mL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300) | 458 ± 179 |
Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*pg/mL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300) | 183 ± 55 |
Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*pg/mL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700) | 841 ± 233 |
Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*pg/mL | Continuous Subcutaenous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700) | 564 ± 216 |
Participants Mean Level of Progesterone at 0700
| ng/mL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Progesterone Levels at 0700 | 9.5 ± 5.4 |
Participants Mean Level of Progesterone at 0700
| ng/mL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Progesterone Level at 0700 | 0.8 ± 0.4 |
Participants Mean Level of Progesterone area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*ng/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Progesterone Area Under the Curve (AUC) - 24 Hours | 101.1 ± 48.8 |
Participants Mean Level of Progesterone area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*ng/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Progesterone Area Under the Curve (AUC) - 24 Hours | 13.7 ± 4.6 |
Participants Mean Level of Progesterone area under the curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*ng/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Progesterone Area Under the Curve (AUC) - Daytime (0700-1500) | 42.2 ± 20.0 |
Participants Mean Level of Progesterone area under the curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*ng/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Progesterone Area Under the Curve (AUC) - Daytime (0700-1500) | 4.2 ± 1.6 |
Participants Mean Level of Progesterone area under the curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*ng/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Progesterone Area Under the Curve (AUC) - Midday (1500 - 2300) | 30.7 ± 17.7 |
Participants Mean Level of Progesterone area under the curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*ng/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Progesterone Area Under the Curve (AUC) - Midday (1500 - 2300) | 5.5 ± 3.2 |
Participants Mean Level of Progesterone area under the curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*ng/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Progesterone Area Under the Curve (AUC) - Nighttime (2300 - 0700) | 28.2 ± 12.5 |
Participants Mean Level of Progesterone area under the curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
| h*ng/dL | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participants Mean Level of Progesterone Area Under the Curve (AUC) - Nighttime (2300 - 0700) | 4.0 ± 0.5 |
lean body mass measured by DEXA, Hologic Discovery-A
| kg | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participant Lean Body Mass | 60.7 ± 3.7 |
lean body mass measured by DEXA, Hologic Discovery-A
| kg | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| Participant Lean Body Mass | 64.3 ± 4.4 |
Collected over At 6 months. Subjects that select the option of continuing CSHI therapy for 1 additional year will be monitored for 1 year, 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Continuous Subcutaneous Hydrocortisone Infusion | 0/8 (0%) | 0/8 (0%) | 8/8 (100%) |
| Event | Continuous Subcutaneous Hydrocortisone Infusion |
|---|---|
| FatigueGeneral disorders | 7/8 |
| HeadacheNervous system disorders | 7/8 |
| Increased appetiteGastrointestinal disorders | 6/8 |
| Local skin infection at the infusion set siteSkin and subcutaneous tissue disorders | 5/8 |
| DizzinessNervous system disorders | 5/8 |
| LightheadednessNervous system disorders | 5/8 |
| Difficulty falling asleep or frequent wakeningGeneral disorders | 5/8 |
| Weight gainGeneral disorders | 5/8 |
| Skin erythema with pruritis at the infusion set siteSkin and subcutaneous tissue disorders | 3/8 |
| WeaknessMusculoskeletal and connective tissue disorders | 3/8 |
| Age, Categorical(Participants) | Continuous Sub-Q Hydrocortisone Infusion |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Continuous Sub-Q Hydrocortisone Infusion |
|---|---|
| Female | 5 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Continuous Sub-Q Hydrocortisone Infusion |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Continuous Sub-Q Hydrocortisone Infusion |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Continuous Sub-Q Hydrocortisone Infusion |
|---|---|
| United States | 5 |
| Canada | 3 |
| Phenotype(Participants) | Continuous Sub-Q Hydrocortisone Infusion |
|---|---|
| Simple Virilizing (SV) | 2 |
| Salt-wasting (SW) | 6 |
The record gives a start of May 2013, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2017, 11 months after primary completion.
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Studies of the drug tested here: Hydrocortisone
National Institutes of Health Clinical Center (CC) →