Actively Recruiting

Phase 2
Age: 18Years - 38Years
FEMALE
Healthy Volunteers
NCT06686537

Convergent Mechanisms Underlying Reprometabolic Syndrome in Women

Led by University of Colorado, Denver · Updated on 2025-05-01

20

Participants Needed

2

Research Sites

92 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

C

Colorado Clinical & Translational Sciences Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Convergent Mechanisms Underlying Reprometabolic Syndrome in Women

Who Can Participate

Age: 18Years - 38Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

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Trial Site Locations

Total: 2 locations

1

University of Colorado School of Medicine

Aurora, Colorado, United States, 80045

Not Yet Recruiting

2

University of Colorado-School of Medicine

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

K

Katherine Kuhn

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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