Convergent Mechanisms Underlying Reprometabolic Syndrome in Women
Part of paid clinical trials in Aurora, Colorado.
- Sponsor
- University of Colorado, Denver
- Study ID
- NCT06686537
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Infertility, Female
- Obesity
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 38 Years
- Healthy Volunteers
- Accepted
Interventions
- Estradiol Patches — DRUGEstradiol patched will be worn for 7 days.
Study Details
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.
Key Dates
- Start date
- Feb 25, 2025
- Status verified
- Apr 2025
- Primary completion
- Oct 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Estradiol Patch- Normal Weight womenNormal weight women (NWW) will wear a Transdermal estradiol patch for 7 days and collect urine to determine LH surge.
- Experimental: Estradiol Patch- Women with high BMIWomen with a BMI greater than 30 kg/m2 will wear a Transdermal estradiol patch for 7 days and collect urine to determine LH surge.
Primary Outcome Measure
Amount of Luteinizing hormone Surge [ Time Frame: From enrollment to the end of treatment is 7 days. ]
Central Contacts
- Katherine Kuhn303-724-5276
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Colorado School of Medicine | Aurora | Colorado | 80045 | - |
| University of Colorado-School of Medicine | Aurora | Colorado | 80045 |
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