Estradiol Patches for Female Infertility

Overseen by Nanette 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.

Research Team

Nanette Santoro, MD

Principal Investigator

University of Colorado School of Medicine

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.

No history of chronic disease impacting reproductive hormones

Treatment Details

Interventions

• Estradiol (Hormone Therapy)

Trial Overview 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.

Participant Groups

Group I: Estradiol Patch- Women with high BMI Experimental Treatment 1 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 women Experimental Treatment 1 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 Canada for the following indications:

Approved in Canada as Estradiol for:

• Menopausal symptoms
• Hypoestrogenism
• Osteoporosis prevention
• Breast cancer palliation
• Prostate cancer palliation

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Colorado Clinical & Translational Sciences Institute

Collaborator

Trials

21

Recruited

1,400+