Estradiol and Elagolix for Menopause

Recruiting in Palo Alto (17 mi)

Overseen byW. Larry Kenney, Ph.D.

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Penn State University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The frequency and severity of heat waves has increased in the last decades. Older adults (over 65 years) have impaired responses to heat stress making them at increased risk for adverse events. Previous heat waves report that women over 65 experience worse health outcomes than any other age group and age matched men. Aging and reproductive hormones, specifically estrogen, independently alter responses to heat stress. However, the combined effects of low estrogen following menopause and aging on the response to heat stress are unknown. In this study, the investigators will identify the role of estrogen in pre and post menopausal women on thermoregulatory responses to heat stress.

Eligibility Criteria

This trial is for postmenopausal women over the age of 65 who are experiencing issues with body temperature regulation. Participants should not have any conditions that could interfere with hormone therapy or thermoregulation studies.

Inclusion Criteria

I am a woman aged between 42 and 64.

Exclusion Criteria

High-risk determined by the Atherosclerotic Cardiovascular Disease (CVD) Risk Factor Assessment

I am currently on hormone therapy.

I have a history of Crohn's disease or similar bowel conditions.

See 3 more

Treatment Details

Interventions

Estradiol patch (Hormone Therapy)

Trial OverviewThe study tests how estrogen affects body heat management in older women. It involves an estradiol patch, which provides estrogen, and Elagolix Oral Tablet to counteract it, compared against placebo counterparts in a controlled environment.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Premenopausal estrogen suppressionExperimental Treatment2 Interventions

Participants take a cellulose placebo tablet for 4 days prior to baseline testing and continue until experimental visits are complete. Following completion of placebo testing, participants begin taking 400 mg/day Elagolix for 4 days prior to testing and continue until experimental visits are complete.

Group II: Postmenopausal estrogen supplementationExperimental Treatment2 Interventions

Participants wear a transdermal estradiol patch or placebo patch for 5 days prior to testing and continue until experimental visits are complete. After 48 hr washout, participants then wear the alternative treatment for 5 days prior to testing until experimental visits are complete.