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.
This is an open-label, single site study in pre-menopausal women aged 18-40 years old with a history of regular menstrual cycles (25-35 days long) of normal BMI or high BMI. The objective of the study is to determine the effects of an estradiol patch on luteinizing hormone rise in both cohorts. The study consists of 2 periods: a screening period of up to 3 weeks and a Treatment Period of 7-10 days. During the treatment period participants will wear estradiol patches for up to 7 days and have on blood draw on day 3 of wearing the patches. Participants will also collect daily morning urine for all the days they wear the patches. Participants will use a reliable barrier method of birth control or abstain from intercourse for the duration of the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
Estradiol patched will be worn for 7 days.
University of Colorado School of Medicine
Aurora, Colorado, United States
NOT_YET_RECRUITINGUniversity of Colorado-School of Medicine
Aurora, Colorado, United States
RECRUITINGAmount 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.
Time of Luteinizing Hormone Peak
Specific day of highest urinary luteinizing hormone concentration (in days)
Time frame: From enrollment to 7 days
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