A Treatment Study for Premenstrual Syndrome (PMS)

Summary

This study examines the effects of estrogen and progesterone on mood, the stress response, and brain function and behavior in women with premenstrual syndrome.

Previously this study has demonstrated leuprolide acetate (Lupron (Registered Trademark)) to be an effective treatment for PMS. The current 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 women with PMS.

PMS is a condition characterized by changes in mood and behavior that occur during the second phase of the normal menstrual cycle (luteal phase). This study will investigate possible hormonal causes of PMS by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. The results of these hormonal studies will be compared between women with PMS and healthy volunteers without PMS (see also protocol 92-M-0174).

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

• Premenstrual Syndrome
• Menstruation Disturbances

Interventions

DRUG

Leuprolide

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

DRUG

Estradiol Patches

Transdermal Estradiol, 100mcg/day by skin patch

DRUG

Progesterone

Progesterone suppository, 200mg vaginally twice/day

DRUG

Placebo patch

Placebo by skin patch

DRUG

Placebo injection

Placebo given intramuscularly monthly

DRUG

Placebo suppository

Placebo vaginal suppository

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

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

1992-08-11

Primary Completion

2020-02-06

Completion

2020-02-06

FDA Drug

Yes

Countries

• United States

Study Locations