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Estradiol Response in Reprometabolic Syndrome
NCT06686537Phase 2
Key facts
- Status
- Recruiting
- Start
- Feb 2025
- Primary completion
- Oct 2027
- Countries
- 1
- Sponsor
- University of Colorado Denver
- Modality
- Hormone, Biologic
- Drugs
- estradiol
- Conditions
- obesityfemale infertility
01
Overview
Phase 2, open-label trial of estradiol in obesity and female infertility (2 arms), sponsored by University of Colorado Denver. Primary endpoint: Amount of Luteinizing hormone Surge at 7 days. Started Feb 2025; status: recruiting.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Normal Weight women
Normal weight women (NWW) wearing a Transdermal estradiol patch for 7 days.
Women with high BMI
Women with a BMI greater than 30 kg/m2 wearing a Transdermal estradiol patch for 7 days.
03
Who it enrols
Pre-menopausal women aged 18-38 with regular menstrual cycles, either normal weight or BMI > 30 kg/m2, excluding those with diabetes, smoking history, or VTE.
04
Endpoints
Primary
Amount of Luteinizing hormone Surge
Secondary
Time of Luteinizing Hormone Peak
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