A Treatment Study for Premenstrual Syndrome (PMS)

What Was Tested

In this phase 1 trial, researchers set out to test Leuprolide.

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

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.

It had seven arms (groups): Study 1, Phase 1, Assignment 1 - Placebo (placebo comparator), Study 1, Phase 1, Assignment 2 - GnRH agonist injections (Lupron-L only) (experimental), Study 1, Phase 2, Arm 1 - Estradiol, then progesterone (experimental), Study 1, Phase 2, Arm 2 - Progesterone, then estradiol (experimental) and Study 2, Phase 1 - GnRH agonist injections (Lupron-L only) (experimental).

As part of double Blind randomized trial, participants in Assignment 1 were randomized to 8 weeks of placebo (P) injections (1 injection per month). These participants then continued on to Study 2 after completion of 8 weeks of placebo injections.

The registry classes the interventions as drug.

More on the Plan

This protocol is designed to accompany Clinical Protocol # 81-M-0126, The Phenomenology and Biophysiology of Menstrually-Related Mood and Behavioral Disorders.

Additionally, women with MRMD but not asymptomatic controls (participating in companion protocol 92-M-0174) experienced a recurrence of mood and behavioral symptoms when either estradiol or progesterone (but not placebo) was added back.

Planned studies include the following: cognitive testing, brain imaging \[(3D-positron emission tomography (PET), functional magnetic resonance imaging (FMRI), magnetic resonance spectroscopy (MRS)\] and genetic studies including induced pluripotent cells.

Who Took Part

Enrollment: 60 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Symptoms should have a sudden onset and offset;.

The full record lists 6 inclusion and 18 exclusion criteria; among the exclusions: current axis i psychiatric diagnosis; history consistent with endometriosis,; hepatic disease as manifested by abnormal liver function tests,.

How the Study Was Run

Design: non-randomized, crossover and triple-blind.

Each person switched between Leuprolide and the comparison at some point, usually with a gap in between.

As a double-blind Leuprolide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 1992-08-11 with completion listed for 2020-02-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean Beck Depression Inventory Score (time frame: Placebo: Weeks 6 and 8 of Placebo; Lupron only: Weeks 6 and 8 or 10 and 12; Estradiol or progesterone: Weeks 2 and 4).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Leuprolide in 60 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, all human trials.