Cardiometabolic Consequences of the Loss of Ovarian Function

PHASE4RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 1, 2024

Primary Completion Date

May 31, 2028

Study Completion Date

August 31, 2028

Conditions
MenopauseEstrogen DeficiencyAgingAdiposity
Interventions
DRUG

Degarelix

After first undergoing a pregnancy test, a clinician will administer an 80-mg subcutaneous injection of degarelix acetate (20 mg/mL; Ferring Pharmaceuticals Inc, Parsippany, NJ) to the women. A second injection will occur at 10 weeks. Compliance to the intervention will be ensured by having participants receive injections in the Clinical and Translational Research Center (CTRC), where all study visits will take place.

DRUG

Transdermal Estradiol Patch

Treatment will be a weekly transdermal patch (0.075 mg) administered in a double-blinded manner. This estradiol dose increases serum estradiol to \~90 pg/mL. Compliance to the intervention will be monitored by having participants keep a log that tracks patch use.

DRUG

Transdermal Placebo Patch

Treatment will be a weekly transdermal patch (placebo inactive) administered in a double-blinded manner. Compliance to the intervention will be monitored by having participants keep a log that tracks patch use.

Trial Locations (1)

80045

RECRUITING

University of Colorado Anschutz Medical Campus, Aurora

All Listed Sponsors
collaborator

National Institute on Aging (NIA)

NIH

lead

University of Colorado, Denver

OTHER