Convergent Mechanisms Underlying Reprometabolic Syndrome in Women

April 30, 2025 updated by: University of Colorado, Denver

Convergent Mechanisms Underlying Reprometabolic Syndrome in Women and Sheep

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • University of Colorado School of Medicine
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado-School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Estradiol Patches
Estradiol patched will be worn for 7 days.
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.
Drug: Estradiol Patches
Estradiol patched will be worn for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Luteinizing hormone Surge
Time Frame: From enrollment to the end of treatment is 7 days.
Urinary luteinizing hormone concentration in mIU/mg of Creatinine
From enrollment to the end of treatment is 7 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of Luteinizing Hormone Peak
Time Frame: From enrollment to 7 days
Specific day of highest urinary luteinizing hormone concentration (in days)
From enrollment to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Colorado Clinical & Translational Sciences Institute

Investigators

  • Principal Investigator: Nanette Santoro, MD, University of Colorado School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 11, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Actual)

November 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-1269
  • CO-C-24-218 (Other Identifier: U of Colorado CCTSI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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