Investigating how obesity affects hormone responses in women
Official title: Convergent Mechanisms Underlying Reprometabolic Syndrome in Women and Sheep
Run by University of Colorado, Denver · NCT06686537 · Data updated 2026-11-12
This study is testing how obesity affects hormone responses in pre-menopausal women by using estradiol patches and measuring hormone levels over a week.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 38 Years |
| Sex | Women only |
| Enrollment | 20 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Status | Recruiting |
| Started | February 25, 2025 |
| Main results expected | October 2027 |
| Study ends | December 2027 |
| Registry record updated | July 21, 2026 |
| Trial ID | NCT06686537 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pre-menopausal women aged 18-40 with regular menstrual cycles and a normal or high BMI.
✕Probably not a fit
Patients with diabetes, a history of venous thromboembolism, or those who smoke may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study aims to explore the impact of obesity on the hormonal response in pre-menopausal women, specifically focusing on the estradiol response at the pituitary and hypothalamus levels. Participants aged 18-40 with regular menstrual cycles will wear estradiol patches for up to 7 days, during which blood samples and urine collections will be conducted to assess luteinizing hormone levels. The study will include a screening period of up to 3 weeks followed by a treatment period of 7-10 days, ensuring participants meet specific health criteria and use reliable contraception. The goal is to understand how obesity influences reproductive hormone dynamics.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for infertility in obese women.
How similar studies have gone: Other studies have shown varying degrees of success in understanding hormonal responses in obesity, but this specific approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Colorado School of Medicine
Aurora, Colorado, United States Recruiting -
University of Colorado-School of Medicine
Aurora, Colorado, United States Recruiting
Study contacts
- Principal investigator: Nanette Santoro, MD — University of Colorado School of Medicine
- Study coordinator: Carrie Hsu
- Email: Carire.Hsu@cuanschutz.edu
- Phone: 303-724-5276
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.