Medical Treatment of Endometriosis-Associated Pelvic Pain

What Was Tested

The trial (phase 3) is built around Leuprolide for endometriosis.

This comparison will be based on a randomized, double-blind, trial of women with chronic pelvic pain who have been diagnosed with endometriosis at the time of surgery within the last 3 years.

The registry classes the interventions as drug.

More on the Plan

This intake visit is estimated to last 1-2 hours.

Blood pressure and weight will be recorded and a urine pregnancy test will be obtained.

The Study Coordinator will review with the patient any concerns she might have and record any adverse events.

Assessments of pain and quality of life will be made at weeks 4, 12, 24, 36 and 48 after the intake visit.

Who Took Part

Enrollment: 194 planned participants were the target.

It was open to women only aged from 18 years up to 52 years.

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

Examples of who could join: Age greater than 18 and pre-menopausal. Pelvic pain of at least 3 months duration. Moderate to severe pelvic pain preoperatively attributable to endometriosis (average Numerical Rating Scale of 5 or more for three or more months). Willingness to comply with visit schedule and protocol.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: use of oral contraceptives within one month of the surgery; history of hysterectomy and bilateral salpingoophorectomy; positive pregnancy test at first postoperative (i.e, intake visit).

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

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

Neither the endometriosis participants nor the staff measuring them knew who was on Leuprolide, so expectations could not easily colour the readings.

It started in 2004-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): pain. quality of life.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 194 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.