Clinical trial
Convergent Mechanisms Underlying Reprometabolic Syndrome in Women
Recruiting now · Phase 2 · 1 countries · Registry ID NCT06686537
Recruiting nowPhase 2Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 38 Years
SexFemale
Healthy volunteersAccepted
ConditionInfertility, Female, Obesity
Full registry 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
Treatments and study arms
Estradiol Patches
Drug
Estradiol patched will be worn for 7 days.
Primary outcomes
Amount of Luteinizing hormone SurgeFrom enrollment to the end of treatment is 7 days.
Urinary luteinizing hormone concentration in mIU/mg of Creatinine
Study locations
2 locations were listed when this page was built. The first 40 are shown.
University of Colorado School of Medicine🇺🇸 Aurora, Colorado, United States
University of Colorado-School of Medicine🇺🇸 Aurora, Colorado, United States
Asma Giornazi, MSContact