Estradiol Patches for Female Infertility

Recruiting in Palo Alto (17 mi)

Overseen ByNanette Santoro, MD

Age: 18 - 65

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Prior Safety Data

Approved in 3 jurisdictions

Trial Summary

What is the purpose of 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 is for women who are dealing with obesity and infertility. Participants should have a body mass index (BMI) that classifies them as obese and be experiencing difficulties in conceiving. Specific details about inclusion or exclusion criteria were not provided, so interested individuals should contact the study organizers for more information.

Inclusion Criteria

I haven't used any hormonal birth control or hormone replacement therapy in the last 3 months.

I am between 18 and 38 years old.

I have never been diagnosed with diabetes.

I have never had blood clots or a clotting disorder.

I am not taking any medications that affect my hormones.

I have never had a cancer that grows in response to estrogen.

Participant Groups

The trial is investigating how obesity affects the response to estradiol, a form of estrogen, at the brain level. It will look at whether overweight impacts hormone surges related to fertility using estradiol patches and testing their effect on hormone release in obese women.

2Treatment groups

Experimental Treatment

Group I: Estradiol Patch- Women with high BMIExperimental Treatment1 Intervention

Women with a BMI greater than 30 kg/m2 will wear a Transdermal estradiol patch for 7 days and collect urine to determine LH surge.

Group II: Estradiol Patch- Normal Weight womenExperimental Treatment1 Intervention

Normal weight women (NWW) will wear a Transdermal estradiol patch for 7 days and collect urine to determine LH surge.

Estradiol is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Estradiol for: