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Search / Trial NCT06686537

Convergent Mechanisms Underlying Reprometabolic Syndrome in Women

Launched by UNIVERSITY OF COLORADO, DENVER · Nov 11, 2024

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

Obesity Infertility Hypothalamic Pituitary Ovarian Axis Pituitary Dysfunction

ClinConnect Summary

This clinical trial, led by Dr. Nanette Santoro, is studying how obesity affects hormone responses related to fertility in women. Specifically, the researchers want to understand if being overweight changes the way the body reacts to certain hormones that are important for regulating menstrual cycles and fertility. They will look at how a hormone called estradiol influences another hormone surge that helps with ovulation in obese women.

To participate in this study, women aged 18 to 38 who have regular menstrual cycles and are not using any reproductive hormones or medications that could affect hormone levels may be eligible. Participants will need to agree to use reliable birth control or avoid sex during the study. It's important to note that women with certain health conditions, like diabetes or a history of blood clots, cannot participate. If you join this trial, you can expect to contribute to important research that could help improve fertility treatments for women dealing with obesity. The study is not yet recruiting participants, so more information will be available soon.

Gender

FEMALE

Eligibility criteria

  • 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

About University Of Colorado, Denver

The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.

Locations

Aurora, Colorado, United States

Aurora, Colorado, United States

Patients applied

0 patients applied

Trial Officials

Nanette Santoro, MD

Principal Investigator

University of Colorado School of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported