CompletedNCT00608062SHAPEUpdated Dec 24, 2020Results posted

Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women

An interventional study of GnRHant - Ganirelix acetate and Transdermal estradiol patch in Arterial Stiffening, Aging and Menopause, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-24.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 155
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: Female

Study summary

The purpose of this study is to find out why women's arteries stiffen as they go through menopause, and how this is affected by estrogen loss. We believe that arteries stiffen with the loss of estrogen because of "oxidative stress," the production of molecules that can damage cells and tissues in the body, and because the arteries lose their ability to expand, or dilate.

Read the detailed description

As women get older and go through menopause, estradiol levels decrease. Also with aging, the arteries that are located around the heart get stiffer. Over time this increase in arterial stiffness can lead to a number of health problems such as high blood pressure and heart disease. In this study we want to find out if a short-term drop in estrogen levels in premenopausal and perimenopausal women can cause arteries to become stiffer, and why this happens. Additionally, in postmenopausal women, we want to find out if a short-term increase in estrogen levels causes their arteries to become more flexible (less stiff).

Arterial health (i.e., stiffness) will be examined in premenopausal, perimenopausal and postmenopausal women before and after they are given a drug called Ganirelix™ (for 7 days), which will markedly lower their reproductive hormones. After the first 4 days of taking Ganirelix™, the women will be randomly placed into 1 of 2 treatment groups to take either estrogen (0.075 mg/d skin patch) replacement or placebo for the rest of the Ganirelix treatment. This is to increase estrogen levels back to the normal level. After having the patch on for 4 days, arterial health will be examined again.

Pre-specified Outcome Measures were divided into unit-of-measurement specific Outcome Measure tables for the purposes of results reporting to ClinicalTrials.gov

Conditions studied

Arterial Stiffening
Aging
Menopause

Keywords

endothelial function
women
female
estrogen deficiency
sex hormones
adiposity
oxidative stress
antioxidants

In context

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

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

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy women of all races and ethnic backgrounds in one of the following groups:
- Premenopausal: 18-49 years, regular menstrual cycles with no change in observed cycle length (21-35 days)
- Perimenopausal: 40-55 years, categorized as either early (at least 2 cycles with cycle length changes of at least 7 days) or late (more than 3 months of amenorrhea) transition
- Postmenopausal: 45-70 years, more than 12 months of amenorrhea as defined by the menopausal staging system (STRAW); additionally, postmenopausal women will be categorized into early and late stages as defined by the STRAW definition, specifically, women who are less than 5 years postmenopause will be considered early, and women more than 6 years will be categorized as late
All postmenopausal women will have undergone natural menopause
No oral contraceptive or Hormone Replacement Therapy (HRT) use for at least 6 months
Resting blood pressure less than 140/90 mmHg
Plasma glucose concentrations less than 110 mg/dl under fasting conditions
Sedentary or recreationally active (less than 3 days of vigorous aerobic exercise)
No use of medications that might influence cardiovascular function
Nonsmokers
No use of vitamin supplements or willing to stop use for duration of the study

Exclusion criteria

Exclusion Criteria:

History of or active estrogen-dependent neoplasms, acute liver or gallbladder disease, vaginal bleeding, venous thromboembolism, hypertriglyceridemia, and cardiovascular disease
Known allergy to transdermal patch or GnRHant
Other contraindications to HRT and GnRHant

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 155 participants (actual)

Study arms

Experimental
Pre1
Premenopausal - GnRHant plus estradiol
Drug: GnRHant - Ganirelix acetate · Drug: Transdermal estradiol patch
Placebo comparator
Pre2
Premenopausal - GnRHant plus placebo
Drug: GnRHant - Ganirelix acetate · Drug: Transdermal placebo patch
Experimental
Peri1
Perimenopausal (early) - GnRHant plus estradiol
Drug: GnRHant - Ganirelix acetate · Drug: Transdermal estradiol patch
Placebo comparator
Peri2
Perimenopausal (early) - GnRHant plus placebo
Drug: GnRHant - Ganirelix acetate · Drug: Transdermal placebo patch
Experimental
Peri3
Perimenopausal (late) - GnRHant plus estradiol
Drug: GnRHant - Ganirelix acetate · Drug: Transdermal estradiol patch
Placebo comparator
Peri4
Perimenopausal (late) - GnRHant plus placebo
Drug: GnRHant - Ganirelix acetate · Drug: Transdermal placebo patch
Experimental
Post1
Postmenopausal - GnRHant plus estradiol
Drug: GnRHant - Ganirelix acetate · Drug: Transdermal estradiol patch
Placebo comparator
Post2
Postmenopausal - GnRHant plus placebo
Drug: GnRHant - Ganirelix acetate · Drug: Transdermal placebo patch

Interventions

DrugGnRHant - Ganirelix acetate
1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7
Also known as: Ganirelix
DrugTransdermal estradiol patch
0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)
DrugTransdermal placebo patch
Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)

What researchers measure

Primary outcomes

Arterial Stiffness (Carotid Artery Compliance) During Saline
Carotid artery compliance measured by carotid artery ultrasound and brachial artery blood pressure
Time frame: Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment
Endothelial Function
Brachial artery flow-mediated dilation (FMD) assessed by ultrasound. This other outcome measure was originally specified as "Secondary" in error and has been updated to "Primary" to be consistent with the protocol.
Time frame: Baseline, day 4 of GnRHant and Day 7 of GnRHant and estradiol or placebo treatment

Other outcomes

Supine Brachial Blood Pressures
Time frame: Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment
Estradiol
This other outcome measure was originally specified as "Secondary" in error and has been updated to "Other, Pre-specified" to be consistent with the protocol. Serum estradiol for clinical characteristics and to detect changes in estradiol levels with the interventions.
Time frame: Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment
Progesterone
This other outcome measure was originally specified as "Secondary" in error and has been updated to "Other, Pre-specified" to be consistent with the protocol. Serum progesterone was measured for clinical characteristics and to determine changes in sex hormones.
Time frame: Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back
Total Antioxidant Status (TAS)
This other outcome measure was originally specified as "Secondary" in error and has been updated to "Other, Pre-specified" to be consistent with the protocol. TAS is an antioxidant and is a biomarker of oxidative stress.
Time frame: Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back
Endothelin-1 (ET-1)
This other outcome measure was originally specified as "Secondary" in error and has been updated to "Other, Pre-specified" to be consistent with the protocol.
Time frame: Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back
Plasma Norepinephrine
This other outcome measure was originally specified as "Secondary" in error and has been updated to "Other, Pre-specified" to be consistent with the protocol.
Time frame: Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back

Results

Posted Dec 24, 2020

Limitations and caveats

Budget cuts lead to: 1) endothelial cell protein expression outcome not analyzed and deleted; 2) small numbers of early and late perimenopausal groups, thus, it was collapsed into 1 peri group. Ultrasound image quality also lead to small numbers.

Participant flow

Participants were recruited from the Denver metro area between March 2007 and March 2012. The first participant was enrolled on March 6, 2007 and the last participant was enrolled in March 2012.

Participant flow — Overall Study
Milestone	Pre1	Pre2	Peri1	Peri2	Post1	Post2
Started	12	12	19	21	13	15
Completed	12	12	19	21	13	15
Not completed	0	0	0	0	0	0

Outcome measures

PrimaryArterial Stiffness (Carotid Artery Compliance) During Saline

Carotid artery compliance measured by carotid artery ultrasound and brachial artery blood pressure

Time frame:: Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment
Reported as:: Mean · mm2/mm Hg×10-1

Arterial Stiffness (Carotid Artery Compliance) During Saline
mm2/mm Hg×10-1	Pre1	Pre2	Peri1	Peri2	Post1	Post2
Baseline	1.31 ± 0.27	1.34 ± 0.18	0.90 ± 0.27	1.02 ± 0.33	0.89 ± 0.25	0.74 ± 0.23
GnRHant alone	1.27 ± 0.27	1.19 ± 0.34	0.89 ± 0.27	0.94 ± 0.29	0.85 ± 0.24	0.79 ± 0.22
GnRHant + Add-Back	1.29 ± 0.26	1.14 ± 0.38	0.98 ± 0.27	0.94 ± 0.27	0.92 ± 0.27	0.80 ± 0.19

PrimaryEndothelial Function

Brachial artery flow-mediated dilation (FMD) assessed by ultrasound. This other outcome measure was originally specified as "Secondary" in error and has been updated to "Primary" to be consistent with the protocol.

Time frame:: Baseline, day 4 of GnRHant and Day 7 of GnRHant and estradiol or placebo treatment
Reported as:: Mean · % Diameter Change

Endothelial Function
% Diameter Change	Pre1	Pre2	Peri1	Peri2	Post1	Post2
Baseline	9.8 ± 2.5	11.3 ± 2.5	7.7 ± 2.6	6.1 ± 2.7	5.4 ± 1.7	5.3 ± 2.2
Day 4 of GnRHant alone	7.1 ± 2.3	8.9 ± 2.7	5.8 ± 2	6.6 ± 2	4.9 ± 1.5	4.9 ± 1.4
Day 7 of GnRHant plus treatment	10.6 ± 3.3	7.8 ± 3.0	9.6 ± 3.3	6.1 ± 2.7	8.4 ± 2.4	4.2 ± 1.7
Acute Vitamin C Infusion Day 7	8.4 ± 3.1	11.2 ± 4.8	9.3 ± 3.4	11.2 ± 3.6	7.8 ± 3.4	6.7 ± 2.8

Statistical analysis

Pre1 vs Pre2 vs Peri1 vs Peri2 vs Post1 vs Post2 · Mixed Models Analysis · p = 0.05

Other pre-specifiedSupine Brachial Blood Pressures

Time frame:: Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment
Reported as:: Mean · mmHg

Supine Brachial Blood Pressures
mmHg	Pre1	Pre2	Peri1	Peri2	Post1	Post2
Baseline	102 ± 10	108 ± 9	111 ± 13	109 ± 15	117 ± 10	123 ± 13
Day 4 of GnRHant alone	107 ± 7	111 ± 13	112 ± 12	108 ± 13	116 ± 9	115 ± 8
Day 7 of GnRHant plus treatment	103 ± 10	110 ± 14	108 ± 13	109 ± 16	112 ± 10	111 ± 8

Other pre-specifiedEstradiol

This other outcome measure was originally specified as "Secondary" in error and has been updated to "Other, Pre-specified" to be consistent with the protocol. Serum estradiol for clinical characteristics and to detect changes in estradiol levels with the interventions.

Time frame:: Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment
Reported as:: Median · pmol/L

Estradiol
pmol/L	Pre1	Pre2	Peri1	Peri2	Post1	Post2
Baseline	229 (117 to 332)	270 (128 to 484)	360 (46 to 508)	147 (62 to 316)	39 (37 to 49)	37 (37 to 42)
GnRHant alone	147 (87 to 183)	127 (96 to 243)	92 (37 to 468)	99 (37 to 321)	37 (37 to 42)	37 (37 to 42)
GnRhant+Add-back	202 (140 to 481)	134 (117 to 183)	187 (81 to 569)	106 (37 to 321)	165 (128 to 223)	37 (37 to 39)

Statistical analysis

Pre1 vs Pre2 vs Peri1 vs Peri2 vs Post1 vs Post2 · Mixed Models Analysis · p = 0.05

Other pre-specifiedProgesterone

This other outcome measure was originally specified as "Secondary" in error and has been updated to "Other, Pre-specified" to be consistent with the protocol. Serum progesterone was measured for clinical characteristics and to determine changes in sex hormones.

Time frame:: Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back
Reported as:: Median · nmol/L

Progesterone
nmol/L	Pre1	Pre2	Peri1	Peri2	Post1	Post2
Baseline	1.8 (0.7 to 2.5)	2.1 (1.0 to 3.1)	1.1 (0.6 to 1.9)	1.3 (1.0 to 1.9)	1.1 (0.6 to 1.3)	0.9 (0.6 to 1.3)
GnRHant alone	1.3 (0.4 to 2.9)	1.7 (0.7 to 3.7)	1.0 (0.6 to 1.9)	1.0 (0.6 to 2.5)	1.0 (0.3 to 1.3)	0.6 (0.3 to 1.1)
GnRhant+Add-back	1.0 (0.5 to 2.7)	1.0 (0.6 to 2.1)	0.8 (0.6 to 3.6)	1.6 (0.7 to 4.9)	1.0 (0.6 to 1.0)	0.6 (0.6 to 1.1)

Statistical analysis

Pre1 vs Pre2 vs Peri1 vs Peri2 vs Post1 vs Post2 · Mixed Models Analysis · p = 0.05

Other pre-specifiedTotal Antioxidant Status (TAS)

This other outcome measure was originally specified as "Secondary" in error and has been updated to "Other, Pre-specified" to be consistent with the protocol. TAS is an antioxidant and is a biomarker of oxidative stress.

Time frame:: Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back
Reported as:: Mean · nmol/L

Total Antioxidant Status (TAS)
nmol/L	Pre1	Pre2	Peri1	Peri2	Post1	Post2
Baseline	1.4 ± 0.2	1.4 ± 0.2	1.3 ± 0.2	1.3 ± 0.1	1.3 ± 0.2	1.3 ± 0.2
GnRHant alone	1.4 ± 0.2	1.5 ± 0.1	1.3 ± 0.2	1.3 ± 0.2	1.3 ± 0.1	1.4 ± 0.3
GnRhant+Add-back	1.4 ± 0.1	1.4 ± 0.1	1.3 ± 0.1	1.3 ± 0.1	1.3 ± 0.2	1.3 ± 0.2

Other pre-specifiedEndothelin-1 (ET-1)

This other outcome measure was originally specified as "Secondary" in error and has been updated to "Other, Pre-specified" to be consistent with the protocol.

Time frame:: Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back
Reported as:: Mean · pg/mL

Endothelin-1 (ET-1)
pg/mL	Pre1	Pre2	Peri1	Peri2	Post1	Post2
Baseline	5.2 ± 1.5	5.2 ± 0.9	5.9 ± 1.3	6.2 ± 1.6	6.2 ± 1.4	6.4 ± 1.1
GnRHant alone	5.5 ± 1.7	5.5 ± 0.9	6.0 ± 1.8	5.9 ± 0.9	6.5 ± 2.1	6.5 ± 0.9
GnRhant+Add-back	6.0 ± 1.1	5.0 ± 0.7	5.9 ± 1.6	5.7 ± 1.9	6.0 ± 1.8	6.4 ± 0.9

Other pre-specifiedPlasma Norepinephrine

This other outcome measure was originally specified as "Secondary" in error and has been updated to "Other, Pre-specified" to be consistent with the protocol.

Time frame:: Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back
Reported as:: Median · pg/mL

Plasma Norepinephrine
pg/mL	Pre1	Pre2	Peri1	Peri2	Post1	Post2
Baseline	161 (108 to 230)	184 (101 to 217)	227 (168 to 280)	247 (164 to 295)	231 (127 to 349)	242 (228 to 331)
GnRHant alone	144 (116 to 164)	156 (103 to 252)	235 (183 to 282)	233 (159 to 341)	280 (156 to 362)	217 (180 to 282)
GnRhant+Add-back	146 (118 to 214)	217 (152 to 282)	231 (168 to 295)	217 (152 to 282)	204 (168 to 280)	221 (162 to 303)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Pre1	0/12 (0%)	0/12 (0%)	8/12 (66.7%)
Pre2	0/12 (0%)	0/12 (0%)	4/12 (33.3%)
Peri1	0/19 (0%)	0/19 (0%)	9/19 (47.4%)
Peri2	0/21 (0%)	0/21 (0%)	8/21 (38.1%)
Post1	0/13 (0%)	0/13 (0%)	5/13 (38.5%)
Post2	0/15 (0%)	0/15 (0%)	4/15 (26.7%)

Most frequent other events

Most frequent other events
Event	Pre1	Pre2	Peri1	Peri2	Post1	Post2
Patch irritationSkin and subcutaneous tissue disorders	6/12	2/12	3/19	2/21	2/13	2/15
Vaginal bleedingReproductive system and breast disorders	4/12	2/12	1/19	1/21	0/13	0/15
BloatingGastrointestinal disorders	2/12	1/12	4/19	2/21	2/13	1/15
NauseaGastrointestinal disorders	2/12	1/12	2/19	1/21	0/13	0/15
Other urogenitalReproductive system and breast disorders	1/12	0/12	2/19	1/21	2/13	1/15
Injection site reactionSkin and subcutaneous tissue disorders	1/12	1/12	0/19	3/21	1/13	2/15
Joint PainMusculoskeletal and connective tissue disorders	1/12	1/12	1/19	3/21	0/13	0/15
Cardiovascular/neurologyInjury, poisoning and procedural complications	0/12	0/12	0/19	1/21	0/13	1/15
Breast tendernessReproductive system and breast disorders	0/12	0/12	1/19	1/21	0/13	0/15

Baseline characteristics

For primary outcome brachial artery FMD, 91 completed the study. Four participants did not have usable FMD data due to poor ultrasound image quality or technical issues with image acquisition; baseline analysis and results for the remaining 87 women are presented.

Age, Categorical
Age, Categorical(Participants)	Pre1	Pre2	Peri1	Peri2	Post1	Post2	Total
<=18 years	0	0	0	0	0	0	0
Between 18 and 65 years	12	12	17	21	12	11	85
>=65 years	0	0	0	0	0	2	2

Age, Continuous
Age, Continuous(years)	Pre1	Pre2	Peri1	Peri2	Post1	Post2	Total
Mean	32 ± 8	33 ± 7	49 ± 3	50 ± 4	56 ± 5	60 ± 6	47 ± 11

Sex: Female, Male
Sex: Female, Male(Participants)	Pre1	Pre2	Peri1	Peri2	Post1	Post2	Total
Female	12	12	17	21	12	13	87
Male	0	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Pre1	Pre2	Peri1	Peri2	Post1	Post2	Total
United States	12	12	17	21	12	13	87

Body Mass
Body Mass(kg)	Pre1	Pre2	Peri1	Peri2	Post1	Post2	Total
Mean	66.8 ± 15.6	64.2 ± 11.0	65.6 ± 8.1	68.7 ± 11.9	70.5 ± 14.7	69.7 ± 9.3	67.6 ± 11.7

Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m2)	Pre1	Pre2	Peri1	Peri2	Post1	Post2	Total
Mean	23.8 ± 5.6	24.4 ± 5.3	24.1 ± 3.2	25.2 ± 3.9	26.7 ± 5.9	26.5 ± 2.7	25.1 ± 4.4

Systolic Blood Pressure
Systolic Blood Pressure(mmHg)	Pre1	Pre2	Peri1	Peri2	Post1	Post2	Total
Mean	109 ± 8	110 ± 7	113 ± 14	115 ± 11	117 ± 14	120 ± 14	114 ± 12

Diastolic Blood Pressure
Diastolic Blood Pressure(mmHg)	Pre1	Pre2	Peri1	Peri2	Post1	Post2	Total
Mean	70 ± 7	72 ± 5	71 ± 9	73 ± 6	73 ± 8	74 ± 10	72 ± 8

6 further baseline measures are reported on the registry.

Study locations

1 site

University of Colorado Anschutz Medical Center, Clinical Translational Research Center and Exercise Research Laboratory
Aurora, Colorado 80045, United States

References and documents

Publications

Moreau KL, Donato AJ, Seals DR, DeSouza CA, Tanaka H. Regular exercise, hormone replacement therapy and the age-related decline in carotid arterial compliance in healthy women. Cardiovasc Res. 2003 Mar;57(3):861-8. doi: 10.1016/s0008-6363(02)00777-0. PubMed 12618248 ↗
Moreau KL, Gavin KM, Plum AE, Seals DR. Ascorbic acid selectively improves large elastic artery compliance in postmenopausal women. Hypertension. 2005 Jun;45(6):1107-12. doi: 10.1161/01.HYP.0000165678.63373.8c. Epub 2005 May 2. PubMed 15867135 ↗
Virdis A, Ghiadoni L, Pinto S, Lombardo M, Petraglia F, Gennazzani A, Buralli S, Taddei S, Salvetti A. Mechanisms responsible for endothelial dysfunction associated with acute estrogen deprivation in normotensive women. Circulation. 2000 May 16;101(19):2258-63. doi: 10.1161/01.cir.101.19.2258. PubMed 10811592 ↗
Ihionkhan CE, Chambliss KL, Gibson LL, Hahner LD, Mendelsohn ME, Shaul PW. Estrogen causes dynamic alterations in endothelial estrogen receptor expression. Circ Res. 2002 Nov 1;91(9):814-20. doi: 10.1161/01.res.0000038304.62046.4c. PubMed 12411396 ↗
Eskurza I, Monahan KD, Robinson JA, Seals DR. Effect of acute and chronic ascorbic acid on flow-mediated dilatation with sedentary and physically active human ageing. J Physiol. 2004 Apr 1;556(Pt 1):315-24. doi: 10.1113/jphysiol.2003.057042. Epub 2004 Jan 30. Erratum In: J Physiol. 2004 May 1;556(Pt 3):1014. PubMed 14754992 ↗
Gavin KM, Jankowski C, Kohrt WM, Stauffer BL, Seals DR, Moreau KL. Hysterectomy is associated with large artery stiffening in estrogen-deficient postmenopausal women. Menopause. 2012 Sep;19(9):1000-7. doi: 10.1097/gme.0b013e31825040f9. PubMed 22692329 ↗
Moreau KL, Meditz A, Deane KD, Kohrt WM. Tetrahydrobiopterin improves endothelial function and decreases arterial stiffness in estrogen-deficient postmenopausal women. Am J Physiol Heart Circ Physiol. 2012 Mar 1;302(5):H1211-8. doi: 10.1152/ajpheart.01065.2011. Epub 2012 Jan 13. PubMed 22245769 ↗
Moreau KL, Hildreth KL, Meditz AL, Deane KD, Kohrt WM. Endothelial function is impaired across the stages of the menopause transition in healthy women. J Clin Endocrinol Metab. 2012 Dec;97(12):4692-700. doi: 10.1210/jc.2012-2244. Epub 2012 Sep 11. PubMed 22969140 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00608062
Lead sponsor: University of Colorado, Denver
Collaborators: National Institute on Aging (NIA)
Responsible party: Sponsor
First posted: Feb 6, 2008
Start date: Mar 2007
Primary completion: Oct 25, 2012
Completion: Oct 25, 2012
Results posted: Dec 24, 2020
Last update: Dec 24, 2020

Study contacts

Kerrie L Moreau, PhD

principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women

Study summary

Conditions studied

Keywords

In context

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Other outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies from this sponsor

Inclusion criteria

Exclusion criteria