Bioenergetic Effects of Aging and Menopause (BEAM)

Summary

The menopause transition is associated with increased risk for weight gain and a shift toward storing fat in the belly region, which may increase risk for cardiovascular disease and diabetes. The study will determine whether the stress hormone cortisol contributes to this shift.

Conditions

• Menopause
• Obesity, Abdominal
• Aging
• Weight Gain

Interventions

DRUG

GnRH antagonist

GnRH antagonist will be given once for premenopausal women (12-week intervention) and twice for postmenopausal women (24-week intervention)

DRUG

Estrogen Product

Estrogen patches will be worn by those randomized to the Estradiol arms in both premenopausal and postmenopausal groups. Patches will be applied weekly and will be worn for the for entirety of the intervention (12 or 24 weeks).

DRUG

Placebo estradiol

Placebo patches will be worn by those randomized to the placebo arms in both premenopausal and postmenopausal groups. Patches will be applied weekly and will be worn for the for entirety of the intervention (12 or 24 weeks).

DRUG

Placebo GnRH antagonist

Postmenopausal women randomized to the placebo injection arm will receive two placebo drug injections of normal saline (24-week intervention)

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Wendy M Kohrt, PhD · University of Colorado, Denver

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-09-24

Primary Completion

2024-08-31

Completion

2024-08-31

FDA Drug

Yes

Countries

• United States

Study Locations