Convergent Mechanisms Underlying Reprometabolic Syndrome in Women

Phase 2

Not yet recruiting

• Conditions: Infertility, Female; Obesity
• Interventions: Drug: Estradiol Patches

• Registration Number: NCT06686537
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Study Start: 2025-01-15
• Primary Completion: 2026-10
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

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

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Exclusion Criteria

• Has diabetes
• Is a smoker
• History of venous thromboembolism or known thrombophilia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Estradiol Patch- Normal Weight women	Estradiol Patches	Normal weight women (NWW) will wear a Transdermal estradiol patch for 7 days and collect urine to determine LH surge.
Estradiol Patch- Women with high BMI	Estradiol Patches	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.

Primary Outcome Measures

Name	Time	Method
Amount of Luteinizing hormone Surge	From enrollment to the end of treatment is 7 days.	Urinary luteinizing hormone concentration in mIU/mg of Creatinine

Secondary Outcome Measures

Name	Time	Method
Time of Luteinizing Hormone Peak	From enrollment to 7 days	Specific day of highest urinary luteinizing hormone concentration (in days)

Trial Locations

Locations (1)

University of Colorado School of Medicine; 🇺🇸 Aurora, Colorado, United States