Psychological Impact of Amenorrhea in Women With Endometriosis

Plain-language guide to NCT02393482: phase 4 randomized trial of Leuprolide, endometriosis, 50 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02393482
Phase: phase 4
Status: status unknown
Start: 2021-06
Completion (planned or actual): 2021-12
Participants: 50 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Amenorrhea; Endometriosis; Quality of Life
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Leuprolide for endometriosis.

The purpose of the study is to evaluate the impact on quality of life, psychological health, sexuality and chronic pain of therapies which determine amenorrhea in symptomatic women with endometriosis, through the administration of self reported questionnaires.

Amenorrhea in the first group is caused by balanced assumption of estroprogestins, in the second group is caused by GnRHa-induced hypoestrogenism.

It had two arms (groups): Balanced estroprogestins (active comparator) and GnRHa (active comparator).

The registry classes the interventions as drug.

Who Took Part

50 planned participants were the target.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Clinical, echographical or surgical diagnosis of endometriosis.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: psychiatric diseases; refusal or inability to sign informed consent.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Leuprolide group and the comparison group ran side by side rather than switching.

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2021-06 with completion listed for 2021-12.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Quality of life (self reported questionnaires) (time frame: 180 days). Sexual health (self reported questionnaires) (time frame: 180 days). Psychological impact (self reported questionnaires) (time frame: 180 days).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide in 50 people with endometriosis.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, Endometriosis research.

Our Notes on the Compound

Leuprolide: A 9-amino-acid GnRH analog (Lupron, Eligard) that lowers sex-hormone levels with ongoing use; used in prostate cancer, endometriosis and early puberty.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.