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CompletedNCT03868059Updated Jun 10, 2021Results posted

Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men

A Phase 3 interventional study of LPCN 1021 in Hypogonadism, Male, sponsored by Lipocine Inc.. Completed at 16 sites in United States. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-06-10.

Sponsored by Lipocine Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Apr 2018, registered Feb 2019).
Phase
Phase 3
Study type
Interventional
Enrollment
138
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
Male
01

Study summary

This is an open-label, multi-center, single arm study evaluating the blood pressure (BP) changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood pressure monitoring (ABPM) in LPCN 1021 treated adult hypogonadal male subjects.

Read the detailed description

This is an open-label, multi-center, single arm study evaluating the blood pressure (BP) changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood pressure monitoring (ABPM) in LPCN 1021 treated adult hypogonadal male subjects.

The study is comprised of six scheduled visits: Visit 1 and 2 are for screening, Visit 3 is to assess subject's baseline BP and pulse rate (PR) via ABPM. Visit 4 is to enroll subjects, and to provide subjects with study medication for the start of dosing. Visit 5 is to assess subject's post-treatment BP and PR via ABPM. Visit 6 is to perform exit visit procedures.

02

Conditions studied

  • Hypogonadism, Male

Browse trials for

03

In context

Eunuchism

75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.

This study's enrollment of 138 is above the median of 60 across 55 interventional studies indexed under Eunuchism.

Browse Eunuchism studies →

Lead sponsor

Lipocine Inc. is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Voluntarily sign and date the study consent form(s) which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures.
  2. Male between 18 and 80 years of age, inclusive, with documented onset of hypogonadism prior to age 65.
  3. Subjects should be diagnosed to be primary (congenital or acquired) or secondary hypogonadal (congenital or acquired).
  4. Serum total T below lab normal range (300 ng/dL) based on two consecutive blood samples obtained between 6 and 10 AM, on two separate days at approximately the same time of day, following an appropriate of current androgen replacement therapy, if required.
  5. Naïve to androgen replacement or has discontinued current treatment and completed adequate washout of prior androgen therapy. Washout must be completed prior to collection of baseline serum T samples to determine study eligibility.
  6. Judged to be in good general health as determined by the investigator at screening.

Exclusion criteria

Exclusion Criteria:

  1. History of significant sensitivity or allergy to androgens, or product .

  2. abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:

    1. \< 11.5 g/dL or > 16.5 g/dL
    2. Hematocrit \< 35% or > 54%
    3. Serum transaminases > 2.5 times
    4. Serum > 2.0 mg/dL
    5. Creatinine > 2.0 mg/dL
    6. PSA > 4 ng/mL
    7. Prolactin > 17.7 ng/mL.
  3. Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up.
  4. Subjects with screening systolic BP or diastolic BP above 160 mmHg or 100 mmHg, respectively.
  5. Subjects with symptoms of moderate to severe benign prostatic hyperplasia.
  6. History of seizures or convulsions occurring after age 5, including alcohol or drug withdrawal seizures.
  7. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
  8. History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration.
  9. Known tolerability issues with ABPM devices.
  10. History of stroke, myocardial infarction, , or acute coronary syndrome within the past 5 years.
  11. History of long syndrome (or QTcB > 450) or unexplained sudden death (including cardiac death) or history of long QT syndrome in a first degree relative (parent, sibling, or child).
  12. Subjects who are not on stable dose of current medication (no changes in medication in the last 3 months).
  13. History of current or suspected prostate or breast cancer.
  14. History of untreated obstructive sleep apnea or not compliant with sleep apnea treatment.
  15. Active alcohol or any drug substance abuse, or history of abuse that will interfere with the subject's ability to participate in the study in the judgement of the investigator.
  16. Use of known inhibitors (e.g., ketoconazole) or inducers (e.g., dexamethasone, phenytoin, rifampin, carbamazepine) of cytochrome P450 3A () within 30 days prior to study drug administration and through the end of the study. A list of prohibited medications is provided in Appendix C.
  17. Use of any drug within 5 half-lives of the last dose in the past 6 months prior to Study Day -2 without principal investigator and/or sponsor approval.
  18. Receipt of any investigational drug by injection within 30 days or 10 half-lives (whichever is longer) prior to study drug administration without principal investigator and/or sponsor approval.
  19. Subject who is not willing to use adequate for the duration of the study.
  20. Any to a MRI scan (i.e. subjects with non-removable ferromagnetic implants, pacemakers, aneurysm clips or other foreign bodies), and/or subjects with claustrophobic symptoms and/or inability to fit into an MRI scanner.
  21. Inability to understand and provide written for the study.
  22. Considered by the investigator or the sponsor-designated physician, for any reason, that the subject is an unsuitable candidate to receive LPCN 1021 (exact reason should be specified by the investigator).
Terms in these criteria, in plain language(13)

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.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
138 participants (actual)

Study arms

  • Experimental
    LPCN 1021

    LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening),

    Drug: LPCN 1021

Interventions

  • DrugLPCN 1021

    LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

    Also known as: TLANDO

06

What researchers measure

Primary outcomes

  1. Change in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP)

    Change in average systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) from Visit 3 (Baseline) to Visit 5 (End of Study)

    Time frame: Baseline to end of study (approximately 4 months).

Secondary outcomes

  1. Change in ABPM-measured Average Daytime SBP

    Change in average daytime SBP as measured by ABPM from Visit 3 to Visit 5

    Time frame: Baseline to End of Study (approximately 4 months)

  2. Change in ABPM-measured Average Nighttime SBP

    Change in average nighttime SBP as measured by ABPM from Visit 3 to Visit 5

    Time frame: Baseline to End of Study (approximately 4 months)

  3. Change in ABPM-measured Average 24-hour Diastolic Blood Pressure (DBP)

    Change in average 24-hour DBP as measured by ABPM from Visit 3 to Visit 5

    Time frame: Baseline to End of Study (approximately 4 months)

  4. Change in ABPM-measured Average Daytime DBP

    Change in average daytime DBP as measured by ABPM from Visit 3 to Visit 5

    Time frame: Baseline to End of Study (approximately 4 months)

  5. Change in ABPM-measured Average Nighttime DBP

    Change in average nighttime DBP as measured by ABPM from Visit 3 to Visit 5

    Time frame: Baseline to End of Study (approximately 4 months)

  6. Change in ABPM-measured Average 24-hour Pulse Rate (PR)

    Change in average 24-hour pulse rate as measured by ABPM from Visit 3 to Visit 5

    Time frame: Baseline to End of Study (approximately 4 months)

  7. Change in ABPM-measured Average Daytime PR

    Change in average daytime pulse rate as measured by ABPM from Visit 3 to Visit 5

    Time frame: Baseline to End of Study (approximately 4 months)

  8. Change in ABPM-measured Average Nighttime PR

    Change in average nighttime pulse rate as measured by ABPM from Visit 3 to Visit 5

    Time frame: Baseline to End of Study (approximately 4 months)

  9. Change in Morning SBP Measured in Triplicate at the Clinic

    Change in morning systolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5

    Time frame: Baseline to End of Study (approximately 4 months)

  10. Change in Morning DBP Measured in Triplicate at the Clinic

    Change in morning diastolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5

    Time frame: Baseline to End of Study (approximately 4 months)

  11. Change in Morning PR Measured in Triplicate at the Clinic

    Change in morning pulse rate measured in triplicate at the clinic from Visit 3 to Visit 5

    Time frame: Baseline to End of Study (approximately 4 months)

  12. Change in Patient Reported Sexual Distress

    Change in patient reported sexual distress from visit 3 to Visit 5 Female Sexual Distress Scale - Revised, Item 13 Possible scores range from 0 (better) to 4 (worse)

    Time frame: Baseline to End of Study (approximately 4 months)

  13. Change in Patient Reported Sexual Desire

    Change in patient reported sexual desire from visit 3 to Visit 5 Psychosexual Daily Questionnaire Possible scores range from 0 (worse) to 5 (better)

    Time frame: Baseline to End of Study (approximately 4 months)

  14. Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥5%

    Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥5%

    Time frame: Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)

  15. Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥5%

    Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥5%

    Time frame: Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)

  16. Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥10%

    Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥10%

    Time frame: Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)

  17. Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥10%

    Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥10%

    Time frame: Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)

Other outcomes

  1. Change is SBP Dip

    Change in systolic blood pressure dip, as defined as the difference between daytime mean systolic blood pressure and nighttime mean systolic blood pressure, from Visit 3 to Visit 5

    Time frame: Baseline to End of Study (approximately 4 months)

  2. Change in ABPM-measured Average 24-hour SBP in Subjects With a Low Framingham Risk Score (FRS)

    Change in average 24-hour SBP in subjects with a low cardiovascular risk based on their Framingham Risk Score (0\<FRS\<11) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0\<FRS\<11; Moderate: 11≤FRS\<24; High: FRS≥24.

    Time frame: Baseline to End of Study (approximately 4 months)

  3. Change in ABPM-measured Average 24-hour SBP in Subjects With a Moderate Framingham Risk Score (FRS)

    Change in average 24-hour SBP in subjects with a moderate cardiovascular risk based on their Framingham Risk Score (11≤FRS\<24) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0\<FRS\<11; Moderate: 11≤FRS\<24; High: FRS≥24.

    Time frame: Baseline to End of Study (approximately 4 months)

  4. Change in ABPM-measured Average 24-hour SBP in Subjects With a High Framingham Risk Score (FRS)

    Change in average 24-hour SBP in subjects with a high cardiovascular risk based on their Framingham Risk Score (FRS≥24) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0\<FRS\<11; Moderate: 11≤FRS\<24; High: FRS≥24.

    Time frame: Baseline to End of Study (approximately 4 months)

  5. Change in ABPM-measured Average 24-hour SBP in Subjects With a Baseline SBP >140mmHg

    Change in average 24-hour SBP as measured by ABPM in subjects with a baseline SBP \>140mmHg from Visit 3 to Visit 5

    Time frame: Baseline to End of Study (approximately 4 months)

  6. Change in Hematocrit From Baseline

    Change in Hematocrit (%) from Visit 3 to Visit 5

    Time frame: Baseline to end of Study (approximately 4 months)

  7. Number of Participants Who Started a New Hypertensive Medication or Increased Their Hypertensive Medication Dose

    Number of participants who had to start a new hypertensive medication or increase their hypertensive medication dose from Visit 3 to Visit 5

    Time frame: Baseline to End of Study (approximately 4 months)

  8. Change in Hemoglobin From Baseline

    Change in Hemoglobin from Visit 3 to Visit 5

    Time frame: Baseline to End of Study (approximately 4 months)

07

Results

Posted Jun 10, 2021

Participant flow

Participant flow — Overall Study
MilestoneLPCN 1021
Started138
Completed126
Not completed12
Withdrew: Adverse event3
Withdrew: Lost to follow-up3
Withdrew: Withdrawal by subject6

Outcome measures

PrimaryChange in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP)

Change in average systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) from Visit 3 (Baseline) to Visit 5 (End of Study)

Time frame:
Baseline to end of study (approximately 4 months).
Reported as:
Mean · mmHg
Change in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP)
mmHgLPCN 1021
Change in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP)3.8 ± 11.8
SecondaryChange in ABPM-measured Average Daytime SBP

Change in average daytime SBP as measured by ABPM from Visit 3 to Visit 5

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · mmHg
Change in ABPM-measured Average Daytime SBP
mmHgLPCN 1021
Change in ABPM-measured Average Daytime SBP5.2 ± 14.9
SecondaryChange in ABPM-measured Average Nighttime SBP

Change in average nighttime SBP as measured by ABPM from Visit 3 to Visit 5

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · mmHg
Change in ABPM-measured Average Nighttime SBP
mmHgLPCN 1021
Change in ABPM-measured Average Nighttime SBP4.3 ± 16.7
SecondaryChange in ABPM-measured Average 24-hour Diastolic Blood Pressure (DBP)

Change in average 24-hour DBP as measured by ABPM from Visit 3 to Visit 5

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · mmHg
Change in ABPM-measured Average 24-hour Diastolic Blood Pressure (DBP)
mmHgLPCN 1021
Change in ABPM-measured Average 24-hour Diastolic Blood Pressure (DBP)1.2 ± 4.9
SecondaryChange in ABPM-measured Average Daytime DBP

Change in average daytime DBP as measured by ABPM from Visit 3 to Visit 5

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · mmHg
Change in ABPM-measured Average Daytime DBP
mmHgLPCN 1021
Change in ABPM-measured Average Daytime DBP1.7 ± 6.5
SecondaryChange in ABPM-measured Average Nighttime DBP

Change in average nighttime DBP as measured by ABPM from Visit 3 to Visit 5

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · mmHg
Change in ABPM-measured Average Nighttime DBP
mmHgLPCN 1021
Change in ABPM-measured Average Nighttime DBP1.7 ± 7.2
SecondaryChange in ABPM-measured Average 24-hour Pulse Rate (PR)

Change in average 24-hour pulse rate as measured by ABPM from Visit 3 to Visit 5

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · bpm
Change in ABPM-measured Average 24-hour Pulse Rate (PR)
bpmLPCN 1021
Change in ABPM-measured Average 24-hour Pulse Rate (PR)2.0 ± 5.9
SecondaryChange in ABPM-measured Average Daytime PR

Change in average daytime pulse rate as measured by ABPM from Visit 3 to Visit 5

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · bpm
Change in ABPM-measured Average Daytime PR
bpmLPCN 1021
Change in ABPM-measured Average Daytime PR2.6 ± 6.9
SecondaryChange in ABPM-measured Average Nighttime PR

Change in average nighttime pulse rate as measured by ABPM from Visit 3 to Visit 5

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · bpm
Change in ABPM-measured Average Nighttime PR
bpmLPCN 1021
Change in ABPM-measured Average Nighttime PR0.44 ± 7.2
SecondaryChange in Morning SBP Measured in Triplicate at the Clinic

Change in morning systolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · mmHg
Change in Morning SBP Measured in Triplicate at the Clinic
mmHgLPCN 1021
Change in Morning SBP Measured in Triplicate at the Clinic4.8 ± 12.4
SecondaryChange in Morning DBP Measured in Triplicate at the Clinic

Change in morning diastolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · mmHg
Change in Morning DBP Measured in Triplicate at the Clinic
mmHgLPCN 1021
Change in Morning DBP Measured in Triplicate at the Clinic1.6 ± 7.9
SecondaryChange in Morning PR Measured in Triplicate at the Clinic

Change in morning pulse rate measured in triplicate at the clinic from Visit 3 to Visit 5

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · bpm
Change in Morning PR Measured in Triplicate at the Clinic
bpmLPCN 1021
Change in Morning PR Measured in Triplicate at the Clinic2.0 ± 9.8
SecondaryChange in Patient Reported Sexual Distress

Change in patient reported sexual distress from visit 3 to Visit 5 Female Sexual Distress Scale - Revised, Item 13 Possible scores range from 0 (better) to 4 (worse)

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · units on a scale
Change in Patient Reported Sexual Distress
units on a scaleLPCN 1021
Change in Patient Reported Sexual Distress-0.3 ± 1.32
SecondaryChange in Patient Reported Sexual Desire

Change in patient reported sexual desire from visit 3 to Visit 5 Psychosexual Daily Questionnaire Possible scores range from 0 (worse) to 5 (better)

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · units on a scale
Change in Patient Reported Sexual Desire
units on a scaleLPCN 1021
Change in Patient Reported Sexual Desire1.2 ± 1.1
SecondaryPercent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥5%

Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥5%

Time frame:
Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)
Reported as:
Mean · % Relative Change
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥5%
% Relative ChangeLPCN 1021
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥5%-13.5 ± 49.0
SecondaryPercent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥5%

Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥5%

Time frame:
Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)
Reported as:
Mean · % Relative Change
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥5%
% Relative ChangeLPCN 1021
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥5%-33.4 ± 31.5
SecondaryPercent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥10%

Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥10%

Time frame:
Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)
Reported as:
Mean · % Relative Change
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥10%
% Relative ChangeLPCN 1021
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥10%-38.5 ± 27.5
SecondaryPercent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥10%

Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥10%

Time frame:
Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)
Reported as:
Mean · % Relative Change
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥10%
% Relative ChangeLPCN 1021
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥10%-39.7 ± 32.6
Other pre-specifiedChange is SBP Dip

Change in systolic blood pressure dip, as defined as the difference between daytime mean systolic blood pressure and nighttime mean systolic blood pressure, from Visit 3 to Visit 5

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · mmHg
Change is SBP Dip
mmHgLPCN 1021
Change is SBP Dip0.5 ± 9.4
Other pre-specifiedChange in ABPM-measured Average 24-hour SBP in Subjects With a Low Framingham Risk Score (FRS)

Change in average 24-hour SBP in subjects with a low cardiovascular risk based on their Framingham Risk Score (0\<FRS\<11) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0\<FRS\<11; Moderate: 11≤FRS\<24; High: FRS≥24.

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · mmHg
Change in ABPM-measured Average 24-hour SBP in Subjects With a Low Framingham Risk Score (FRS)
mmHgLPCN 1021
Change in ABPM-measured Average 24-hour SBP in Subjects With a Low Framingham Risk Score (FRS)2.6 ± 2.7
Other pre-specifiedChange in ABPM-measured Average 24-hour SBP in Subjects With a Moderate Framingham Risk Score (FRS)

Change in average 24-hour SBP in subjects with a moderate cardiovascular risk based on their Framingham Risk Score (11≤FRS\<24) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0\<FRS\<11; Moderate: 11≤FRS\<24; High: FRS≥24.

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · mmHg
Change in ABPM-measured Average 24-hour SBP in Subjects With a Moderate Framingham Risk Score (FRS)
mmHgLPCN 1021
Change in ABPM-measured Average 24-hour SBP in Subjects With a Moderate Framingham Risk Score (FRS)4.8 ± 13.1
Other pre-specifiedChange in ABPM-measured Average 24-hour SBP in Subjects With a High Framingham Risk Score (FRS)

Change in average 24-hour SBP in subjects with a high cardiovascular risk based on their Framingham Risk Score (FRS≥24) from Visit 3 (Baseline) to Visit 5 (End of Study); Risk Level: Low: 0\<FRS\<11; Moderate: 11≤FRS\<24; High: FRS≥24.

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · mmHg
Change in ABPM-measured Average 24-hour SBP in Subjects With a High Framingham Risk Score (FRS)
mmHgLPCN 1021
Change in ABPM-measured Average 24-hour SBP in Subjects With a High Framingham Risk Score (FRS)-1.8 ± 14.9
Other pre-specifiedChange in ABPM-measured Average 24-hour SBP in Subjects With a Baseline SBP >140mmHg

Change in average 24-hour SBP as measured by ABPM in subjects with a baseline SBP \>140mmHg from Visit 3 to Visit 5

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · mmHg
Change in ABPM-measured Average 24-hour SBP in Subjects With a Baseline SBP >140mmHg
mmHgLPCN 1021
Change in ABPM-measured Average 24-hour SBP in Subjects With a Baseline SBP >140mmHg-3.0 ± 13.7
Other pre-specifiedChange in Hematocrit From Baseline

Change in Hematocrit (%) from Visit 3 to Visit 5

Time frame:
Baseline to end of Study (approximately 4 months)
Reported as:
Mean · percentage of hematocrit
Change in Hematocrit From Baseline
percentage of hematocritLPCN 1021
Change in Hematocrit From Baseline3.2 ± 3.6
Other pre-specifiedNumber of Participants Who Started a New Hypertensive Medication or Increased Their Hypertensive Medication Dose

Number of participants who had to start a new hypertensive medication or increase their hypertensive medication dose from Visit 3 to Visit 5

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Count of participants · Participants
Number of Participants Who Started a New Hypertensive Medication or Increased Their Hypertensive Medication Dose
ParticipantsLPCN 1021
Number of Participants Who Started a New Hypertensive Medication or Increased Their Hypertensive Medication Dose2
Other pre-specifiedChange in Hemoglobin From Baseline

Change in Hemoglobin from Visit 3 to Visit 5

Time frame:
Baseline to End of Study (approximately 4 months)
Reported as:
Mean · g/dL
Change in Hemoglobin From Baseline
g/dLLPCN 1021
Change in Hemoglobin From Baseline0.87 ± 1.05

Adverse events

Collected over 4 months. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LPCN 10210/138 (0%)2/138 (1.4%)22/138 (15.9%)
Most frequent serious events
Most frequent serious events
EventLPCN 1021
Psychiatric DisordersPsychiatric disorders1/138
Musculoskeletal and Connective Tissue DisordersMusculoskeletal and connective tissue disorders1/138
Most frequent other events
Most frequent other events
EventLPCN 1021
HypertensionVascular disorders6/138
Upper Respiratory Tract InfectionInfections and infestations5/138
Haematocrit increasedInvestigations4/138
PolycythemiaBlood and lymphatic system disorders2/138
GynaecomastiaReproductive system and breast disorders2/138
HypertriglyceridaemiaMetabolism and nutrition disorders2/138
Type 2 Diabetes MellitusMetabolism and nutrition disorders2/138
DizzinessNervous system disorders2/138
SinusitisInfections and infestations2/138

Baseline characteristics

Safety Set - Subjects who have received at least 1 dose of study drug

Age, Continuous
Age, Continuous(years)LPCN 1021
Mean53.8 ± 10.18
Sex: Female, Male
Sex: Female, Male(Participants)LPCN 1021
Female0
Male138
Race (NIH/OMB)
Race (NIH/OMB)(Participants)LPCN 1021
American Indian or Alaska Native0
Asian3
Native Hawaiian or Other Pacific Islander0
Black or African American25
White109
More than one race0
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)LPCN 1021
United States138
Body Mass Index
Body Mass Index(kg/m^2)LPCN 1021
Mean33.12 ± 5.75
08

Study locations

16 sites
  • Alabama Clinical Therapeutics
    Birmingham, Alabama 35235, United States
  • South Florida Medical Research
    Aventura, Florida 33180, United States
  • Clinical Research of South Florida
    Coral Gables, Florida 33134, United States
  • Neostart Corporation dba AGA Clinical Trials
    Hialeah, Florida 33012, United States
  • Jacksonville Impotence Treatment Center
    Jacksonville, Florida 32223, United States
  • Oviedo Medical Research, LLC
    Oviedo, Florida 32765, United States
  • Clinical Research Center of Florida
    Pompano Beach, Florida 33060, United States
  • Central Kentucky Research Associates, Inc.
    Lexington, Kentucky 40509, United States
  • Regional Urology
    Shreveport, Louisiana 71106, United States
  • AccuMed Research Associates
    Garden City, New York 11530, United States
  • Manhattan Medical Research Practice PLLC
    New York, New York 10016, United States
  • Aventiv Research, Inc.
    Columbus, Ohio 43213, United States
  • Prestige Clinical Research
    Franklin, Ohio 45005, United States
  • Clinical Research Associates, Inc.
    Nashville, Tennessee 37203, United States
  • Granger Medical Clinic
    West Valley City, Utah 84096, United States
  • Rainier Clinical Research Center
    Renton, Washington 98057, United States
09

References and documents

Publications

  • White WB, Dobs A, Carson C, DelConte A, Khera M, Miner M, Shahid M, Kim K, Chidambaram N. Effects of a Novel Oral Testosterone Undecanoate on Ambulatory Blood Pressure in Hypogonadal Men. J Cardiovasc Pharmacol Ther. 2021 Nov;26(6):630-637. doi: 10.1177/10742484211027394. Epub 2021 Jun 30. PubMed 34191621 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03868059
Lead sponsor
Lipocine Inc.
Responsible party
Sponsor
First posted
Mar 8, 2019
Start date
Apr 30, 2018
Primary completion
Feb 19, 2019
Completion
Feb 21, 2019
Results posted
Jun 10, 2021
Last update
Jun 10, 2021

Study contacts

Anthony Delconte, MD
study director · Lipocine Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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