The Effects of Reproductive Hormones on Mood and Behavior

What Was Tested

The trial (phase 1, phase 2) is built around Leuprolide.

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.

It had three arms (groups): Phase 1 - Lupron (experimental), Phase 2, Arm 1 - Estradiol, then progesterone (experimental) and Phase 2, Arm 2 - Progesterone, then estradiol (experimental).

The registry classes the interventions as drug.

More on the Plan

For example, the menstrual cycle may influence the occurrence of seizures in some female epileptics and the performance on certain cognitive tests.

Central nervous system effects of gonadal steroids have been inferred largely from changes in behavior occurring in association with presumed changes in gonadal steroids during the normal menstrual cycle, during the administration of ovarian hormones, or in a gender-specific context.

These inferences are, by definition, indirect and associational in nature and further are incapable of disentangling the effects of hormones which are simultaneously present in women of reproductive age.

This study is designed to address those problems by comparing measures during Lupron-induced hypogonadism with those during replacement with estrogen or progesterone.

Who Took Part

100 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 1 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a non-randomized and crossover study.

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

It started in 1994-06-09 with completion listed for 2020-03-03.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Mean Beck Depression Inventory Score (time frame: Phase 1: Weeks 6 and 8 or 10 and 12; Phase 2: Weeks 2 and 4 of estradiol or progesterone).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, non-randomized trial of Leuprolide in 100 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.