Convergent Mechanisms Underlying Reprometabolic Syndrome in Women
Recruiting · NCT06686537 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Colorado, Denver
View the official record on ClinicalTrials.gov →Interventions studied
Estradiol Patches
What this trial is about
Dr. Nanette Santoro proposes to test the specific question that obesity results in abnormal estradiol response at the level of the pituitary and hypothalamus. This will be shown in diminished pituitary sensitivity to gonadorelin releasing hormone with a reduced estradiol induced luteinizing hormone surge in obese women.
Who can take part
Age range
18 Years to 38 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age 18-38
- Regular menstrual cycles every 25-35 days
- No use of reproductive hormones within the past 3 months
- No use of medications interacting with reproductive hormones
- Agreement to use reliable barrier contraception or to abstain from intercourse for the duration of the study
- Normal thyroid stimulating hormone, prolactin and lipid profiles
- No more than 4 hours of moderate to vigorous intensity exercise per week
- No history of chronic disease impacting reproductive hormones
- No contraindications to administration of estradiol
- No history of estrogen dependent cancer
- Negative pregnancy test
Exclusion criteria
- Has diabetes
- Is a smoker
- History of venous thromboembolism or known thrombophilia
Where it is running
2 locations listed across 1 US state.
- University of Colorado School of Medicine - Aurora, Colorado, United States
- University of Colorado-School of Medicine - Aurora, Colorado, United States