Convergent Mechanisms Underlying Reprometabolic Syndrome in Women
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-38
SponsorUniversity of Colorado, Denver
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Has diabetes
Is a smoker
History of venous thromboembolism or known thrombophilia
Trial design
Design model
Single group
Treatments tested in this trial
Estradiol Patches
DrugEstradiol patched will be worn for 7 days.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Estradiol Patch- Normal Weight womenExperimental treatment 1 intervention
Group B: Estradiol Patch- Women with high BMIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Amount of Luteinizing hormone Surge
Urinary luteinizing hormone concentration in mIU/mg of Creatinine
Time frame
From enrollment to the end of treatment is 7 days.Secondary outcomes
1
Time of Luteinizing Hormone Peak
Specific day of highest urinary luteinizing hormone concentration (in days)
Time frame
From enrollment to 7 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
Colorado Clinical & Translational Sciences Institute
Collaborator
Source ClinicalTrials.gov