Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery

What Was Tested

This registered phase 3 trial tested Leuprolide for endometriosis.

The main question\[s\] it aims to answer are: 1.

Health-related quality of life (HRQoL) 2.

It had four arms (groups): Leuprolide Acetate (active comparator), Dienogest (experimental), Depot medroxyprogesterone acetate (experimental) and Combined Oral Contraceptive (experimental).

The registry classes the interventions as drug.

More on the Plan

Beta estradiol level is measured in the serum, before and after treatment 2.

TNF alpha is measured in the serum, before and after treatment 3.

Evaluation of HRQoL using the Endometriosis Health Profile-30 (EHP-30) 4.

VAS score will be recorded before and after treatment 5.

Who Took Part

Enrollment: 80 actual participants took part.

It was open to women only.

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

The full record lists 0 inclusion and 5 exclusion criteria; among the exclusions: use of any hormonal therapy for endometriosis within the previous 16 weeks; history of severe adverse drug reactions or hypersensitivity to steroid hormones; failure of previous treatment with coc, dmpa used in this study.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Groups ran in parallel: each of the endometriosis participants stayed in one arm throughout.

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

It started in 2023-09-04 with completion listed for 2024-08-19.

It ran at 1 site in Indonesia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: beta estradiol level (time frame: 0 and 12 weeks of treatment). TNF alpha level (time frame: 0 and 12 weeks of treatment).

It also tracked 3 secondary outcomes, for example VAS score, health-related quality of life (HRQoL) and Mass recurrence.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 80 people with endometriosis.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, Endometriosis research.