Understanding Experimentally Induced Hot Flushes

What Was Tested

In this phase 4 trial, researchers set out to test Leuprolide.

The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being.

The investigators will cause hot flushes by giving study participants the hormone medication, leuprolide (Lupron), which is a manufactured (artificial) hormone that makes the body think that it has reached menopause temporarily.

Most women begin to have hot flushes within 4 weeks after taking leuprolide and resume menses 3 months later.

It had two arms (groups): Developed hot flashes (experimental) and Did not develop hot flashes (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 20 actual participants took part.

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

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

Examples of who could join: Women 18-45 years old. Willingness to use barrier methods of contraception during study and after completion of study until menses resume.

The full record lists 4 inclusion and 25 exclusion criteria; among the exclusions: hot flushes; hemoglobin at the screening visit less than 10 gm/dl; abnormal liver function tests.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2005-11-28 with completion listed for 2007-07-24.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Percent Change in Objective Sleep Efficiency (time frame: baseline (before receiving intervention) and 4 weeks after receiving intervention).

It also tracked 1 secondary outcome, for example Change in Subjective Sleep Quality.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Leuprolide in 20 people.

Its size is small, so on its own it can only give an early look.

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.