Convergent Mechanisms Underlying Reprometabolic Syndrome in Women

University of Colorado Denver (CU Denver)

Status and phase: Enrolling; Phase 2

Conditions: Obesity; Infertility, Female

Treatments: Drug: Estradiol Patches

Study type: Interventional

Funder types: Other

Identifiers

NCT06686537

24-1269

CO-C-24-218 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Estradiol Patch- Normal Weight women

Experimental group

Description:

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

Treatment:

Drug: Estradiol Patches

Estradiol Patch- Women with high BMI

Experimental group

Description:

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.

Treatment:

Drug: Estradiol Patches