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NCT Number: NCT06686537

Convergent Mechanisms Underlying Reprometabolic Syndrome in Women

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.

Recruiting

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Key information

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado School of Medicine, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Estradiol Patches

Drug

Estradiol patched will be worn for 7 days.

Primary outcomes

  1. 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

Secondary outcomes

  1. Time of Luteinizing Hormone Peak

    Time frame: From enrollment to 7 days

    Specific day of highest urinary luteinizing hormone concentration (in days)

Study contacts

Contact information is provided by the study sponsor or research team.

Asma Giornazi

CONTACT

[email protected]

Carrie Hsu

CONTACT

[email protected]

303-724-5276

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Colorado Clinical & Translational Sciences Institute

Registry information

Official study title

Convergent Mechanisms Underlying Reprometabolic Syndrome in Women and Sheep

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 13, 2024
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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