Convergent Mechanisms Underlying Reprometabolic Syndrome in Women and Sheep

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 38
Healthy Volunteers: t
View:

• 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

Locations
United States
Colorado
University of Colorado School of Medicine
NOT_YET_RECRUITING
Aurora
University of Colorado-School of Medicine
RECRUITING
Aurora
Contact Information
Primary
Katherine Kuhn
Katherine.Kuhn@cuanshcutz.edu
303-724-5276
Time Frame
Start Date: 2025-02-25
Estimated Completion Date: 2026-12
Participants
Target number of participants: 20
Treatments
Experimental: Estradiol Patch- Normal Weight women
Normal 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 BMI
Women with a BMI greater than 30 kg/m2 will wear a Transdermal estradiol patch for 7 days and collect urine to determine LH surge.
Related Therapeutic Areas
Sponsors
Collaborators: Colorado Clinical & Translational Sciences Institute
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov