NCT06686537 Convergent Mechanisms Underlying Reprometabolic Syndrome in Women
| NCT ID | NCT06686537 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Colorado, Denver |
| Condition | Infertility, Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-02-25 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Nanette Santoro, MD
PRINCIPAL INVESTIGATOR
University of Colorado School of Medicine
Frequently Asked Questions
Who can join the NCT06686537 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 38 Years, studying Infertility, Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06686537 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06686537 currently recruiting?
Yes, NCT06686537 is actively recruiting participants. Contact the research team at Carire.Hsu@cuanschutz.edu for enrollment information.
Where is the NCT06686537 trial being conducted?
This trial is being conducted at Aurora, United States, Aurora, United States.
Who is sponsoring the NCT06686537 clinical trial?
NCT06686537 is sponsored by University of Colorado, Denver. The principal investigator is Nanette Santoro, MD at University of Colorado School of Medicine. The trial plans to enroll 20 participants.