The Effects of Reproductive Hormones on Mood and Behavior

Summary

This study evaluates the effects of estrogen and progesterone on mood, the stress response, and brain function in healthy women.

The purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in healthy volunteer women without PMS.

This study will investigate effects of reproductive hormones by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. Tests (such as brain imaging or stress testing, etc.) will be performed during the different hormonal conditions (low estrogen and progesterone, progesterone add-back, estrogen add-back). The results of these studies will be compared between women without PMS and women with PMS (see also protocol 90-M-0088).

At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.

Conditions

• Healthy Volunteers

Interventions

DRUG

Leuprolide Acetate 3.75

Eight to 12 weeks of GnRH agonist, Leuprolide Acetate 3.75 mg given intramuscularly monthly

DRUG

Estradiol

Transdermal Estradiol, 100mcg/day by skin patch

DRUG

Progesterone

Progesterone suppository, 200mg vaginally twice/day

DRUG

Placebo suppository

Placebo suppository twice daily

DRUG

Placebo patch

Placebo by skin patch

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  lead NIH

Principal Investigators

• Peter J Schmidt, M.D. · National Institute of Mental Health (NIMH)

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

1994-06-09

Primary Completion

2020-03-03

Completion

2020-03-03

FDA Drug

Yes

Countries

• United States

Study Locations