The Menopause Transition: Estrogen Variability, Stress Reactivity and Mood

Summary

Women in the menopause transition ('perimenopause') are exposed to extreme hormone variability, tend to experience a unique set of severe stressors (e.g., divorce, death of loved ones), and are also at substantially elevated risk to suffer from mood and anxiety disorders. The purpose of this research is to understand the mechanisms by which variability in estradiol (E2) is associated with the symptoms of anxiety and anhedonia (loss of interest and pleasure - a common symptom of depression). By stabilizing E2 variability with a hormonal manipulation, this research will determine the degree to which the E2 variability (or E2 levels) plays a causal role in perimenopausal anxiety and anhedonia symptoms and whether it does so by affecting biological responses to stress.

Conditions

• Perimenopausal Disorder
• Stress, Emotional

Interventions

DRUG

Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release

Transdermal Estradiol worn daily for 16 weeks (patch changed every 7 days).

DRUG

Placebo Patch

Matching placebo patches to be worn every day for 16 weeks (patch changed every 7 days).

DRUG

Progesterone Capsule

Micronized progesterone (200 mg) will be administered every day for 12 days during the 9th week of randomization and again following randomization at the 17th week

DRUG

Placebo Oral Capsule

Matching placebo capsules will be administered orally every day for 12 days during the 9th week of randomization and again following randomization at the 17th week.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Susan Girdler, PhD · Research Professor

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-01-24

Primary Completion

2020-05-10

Completion

2020-05-10

FDA Drug

Yes

Countries

• United States

Study Locations