Investigating how obesity affects hormone responses in women
Convergent Mechanisms Underlying Reprometabolic Syndrome in Women and Sheep
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 |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 38 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT06686537 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pre-menopausal women aged 18-40 with regular menstrual cycles and a normal or high BMI.
Not a fit: Patients with diabetes, a history of venous thromboembolism, or those who smoke may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for infertility in obese women.
How similar studies have performed: Other studies have shown varying degrees of success in understanding hormonal responses in obesity, but this specific approach is relatively novel.
Eligibility criteria
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 this trial is running
Aurora, Colorado and 1 other locations
- University of Colorado School of Medicine — Aurora, Colorado, United States (Not_yet_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: Katherine Kuhn
- Email: Katherine.Kuhn@cuanshcutz.edu
- Phone: 303-724-5276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.