Trial · Interventional

CompletedNot applicableResults postedRegistry data

Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women

Short name SHAPE

NCTNCT00608062Other id06-0537Other idR01AG027678

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 155 participants (actual)
Sponsor: University of Colorado, Denver · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Mar 2007
Primary completion: 25 Oct 2012
Completion: 25 Oct 2012
First posted: 6 Feb 2008 (estimated)
Last update posted: 24 Dec 2020
Conditions: Arterial Stiffening · Aging · Menopause

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2007200820092010201120122013

N/A
SHAPE
NCT00608062
Mar 2007 to 25 Oct 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

GnRHant - Ganirelix acetateDrug
Transdermal estradiol patchDrug
Transdermal placebo patchDrug

Arms8

Experimental
Pre1
Premenopausal - GnRHant plus estradiol
Placebo comparator
Pre2
Premenopausal - GnRHant plus placebo
Experimental
Peri1
Perimenopausal (early) - GnRHant plus estradiol
Placebo comparator
Peri2
Perimenopausal (early) - GnRHant plus placebo
Experimental
Peri3
Perimenopausal (late) - GnRHant plus estradiol
Placebo comparator
Peri4
Perimenopausal (late) - GnRHant plus placebo
Experimental
Post1
Postmenopausal - GnRHant plus estradiol
Placebo comparator
Post2
Postmenopausal - GnRHant plus placebo

Primary outcomes2

Outcomes the sponsor listed as primary.

Arterial Stiffness (Carotid Artery Compliance) During Saline
Time frame · Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment
Registry description
Carotid artery compliance measured by carotid artery ultrasound and brachial artery blood pressure
Endothelial Function
Time frame · Baseline, day 4 of GnRHant and Day 7 of GnRHant and estradiol or placebo treatment
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment

Arterial Stiffness (Carotid Artery Compliance) During Saline

Group	Value (mm2/mm Hg×10-1)	Spread
Pre1	1.31	0.27
Pre2	1.34	0.18
Peri1	0.90	0.27
Peri2	1.02	0.33
Post1	0.89	0.25
Post2	0.74	0.23

Primary outcomeMean· Baseline, day 4 of GnRHant and Day 7 of GnRHant and estradiol or placebo treatment

Endothelial Function

Group	Value (% Diameter Change)	Spread
Pre1	9.8	2.5
Pre2	11.3	2.5
Peri1	7.7	2.6
Peri2	6.1	2.7
Post1	5.4	1.7
Post2	5.3	2.2

Secondary and other outcome results(6)

Other pre specified outcomeMean· Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment

Supine Brachial Blood Pressures

Group	Value (mmHg)	Spread
Pre1	102	10
Pre2	108	9
Peri1	111	13
Peri2	109	15
Post1	117	10
Post2	123	13

Other pre specified outcomeMedian· Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment

Estradiol

Group	Value (pmol/L)
Pre1	229
Pre2	270
Peri1	360
Peri2	147
Post1	39
Post2	37

Other pre specified outcomeMedian· Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back

Progesterone

Group	Value (nmol/L)
Pre1	1.8
Pre2	2.1
Peri1	1.1
Peri2	1.3
Post1	1.1
Post2	0.9

Other pre specified outcomeMean· Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back

Total Antioxidant Status (TAS)

Group	Value (nmol/L)	Spread
Pre1	1.4	0.2
Pre2	1.4	0.2
Peri1	1.3	0.2
Peri2	1.3	0.1
Post1	1.3	0.2
Post2	1.3	0.2

Other pre specified outcomeMean· Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back

Endothelin-1 (ET-1)

Group	Value (pg/mL)	Spread
Pre1	5.2	1.5
Pre2	5.2	0.9
Peri1	5.9	1.3
Peri2	6.2	1.6
Post1	6.2	1.4
Post2	6.4	1.1

Other pre specified outcomeMedian· Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back

Plasma Norepinephrine

Group	Value (pg/mL)
Pre1	161
Pre2	184
Peri1	227
Peri2	247
Post1	231
Post2	242

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Pre1Premenopausal - GnRHant plus estradiol GnRHant - 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 Transdermal 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)	0 / 12	0 / 12	8 / 12
Pre2Premenopausal - GnRHant plus placebo GnRHant - 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 Transdermal placebo patch: Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)	0 / 12	0 / 12	4 / 12
Peri1Perimenopausal (early and late combined) - GnRHant plus estradiol GnRHant - 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 Transdermal 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)	0 / 19	0 / 19	9 / 19
Peri2Perimenopausal (early and late combined) - GnRHant plus placebo GnRHant - 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 Transdermal placebo patch: Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)	0 / 21	0 / 21	8 / 21
Post1Postmenopausal - GnRHant plus estradiol GnRHant - 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 Transdermal 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)	0 / 13	0 / 13	5 / 13
Post2Postmenopausal - GnRHant plus placebo GnRHant - 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 Transdermal placebo patch: Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)	0 / 15	0 / 15	4 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

ResultMoreau 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. PMID 22969140

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 70 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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: * 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

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