NCT06686537

Convergent Mechanisms Underlying Reprometabolic Syndrome in Women

Convergent Mechanisms Underlying Reprometabolic Syndrome in Women and Sheep

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is an open-label, single site study in pre-menopausal women aged 18-40 years old with a history of regular menstrual cycles (25-35 days long) of normal BMI or high BMI. The objective of the study is to determine the effects of an estradiol patch on luteinizing hormone rise in both cohorts. The study consists of 2 periods: a screening period of up to 3 weeks and a Treatment Period of 7-10 days. During the treatment period participants will wear estradiol patches for up to 7 days and have on blood draw on day 3 of wearing the patches. Participants will also collect daily morning urine for all the days they wear the patches. Participants will use a reliable barrier method of birth control or abstain from intercourse for the duration of the study.

Conditions

• Infertility, Female
• Obesity

Interventions

Type	Name	Description
DRUG	Estradiol Patches	Estradiol patched will be worn for 7 days.

Timeline

• Start date: 2025-02-25
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2024-11-13
• Last updated: 2025-05-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study