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NCT06686537
Convergent Mechanisms Underlying Reprometabolic Syndrome in Women
Conditions: Infertility, Female, Obesity
Sex: Female
Ages: 18 Years – 38 Years
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 20
Sponsor: University of Colorado, Denver
Location: University of Colorado School of Medicine Aurora Colorado
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
Source: ClinicalTrials.gov (NCT06686537). StuddyBuddy aggregates publicly available trial information.