N/A
N=92
Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women
Arterial Stiffening · Aging · Menopause
Bottom Line
View on ClinicalTrials.gov: NCT00608062 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Arterial Stiffness (Carotid Artery Compliance) During Saline — 1.31; 1.34; 0.90; 1.02 mm2/mm Hg×10-1
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GnRHant - Ganirelix acetate (Drug); Transdermal estradiol patch (Drug); Transdermal placebo patch (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Arterial Stiffness (Carotid Artery Compliance) During Saline |
1.31; 1.34; 0.90; 1.02; 0.89; 0.74 | — |
| PRIMARY Endothelial Function |
9.8; 11.3; 7.7; 6.1; 5.4; 5.3 | 0.05 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00608062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.