Maintenance Therapy of Levonorgestrel-releasing Intrauterine System (LNG-IUS) to Prevent the Recurrence of Symptomatic Endometriosis After Conservative Surgery

What Was Tested

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

It had two arms (groups): LNG-IUS (experimental) and GnRH agonist (active comparator).

The registry classes the interventions as device and drug.

More on the Plan

Participants: This post-surgical medical therapy trial will be undertaken among patients with moderate-severe symptomatic endometriosis (rASRM score \>16, according to the American Society for Reproductive Medicine) or adenomyosis.

Symptomatic endometriosis means menorrhagia or dysmenorrhea.

All patients were surgically treated by a conservative approach (means preserve uterus and ovary).

Patients were evaluated every month for 24 weeks, and at 3,6,9,12,15,18,21,24 months after the end of medical treatment.

Who Took Part

Enrollment: 80 planned participants were the target.

It was open to women only aged from 20 years up to 45 years.

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

Examples of who could join: Patients with moderate-severe symptomatic endometriosis (rASRM score \>16) according to the American Society for Reproductive Medicine) or adenomyosis. Symptomatic endometriosis means menorrhagia or dysmenorrhea. All patients were surgically treated by a conservative approach. Levels of serum CA125 is higher than normal range.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: further desire for child bearing in future 3 years; any treatment for endometriosis within the previous 2 months; any concomitant disease that can be an established cause of chronic pelvic pain and anemia (thalassemia anemia, inflammation sequela, myoma , and pelvic congestion etc).

How the Study Was Run

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

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

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

Being open-label, the Triptorelin study did not mask who received what.

It started in 2008-03 with completion listed for 2009-03.

It ran at 1 site in Taiwan.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Recurrence rate of endometriosis (time frame: 2 years).

What This Means in Plain Language

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

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

More context: the Triptorelin compound page, Endometriosis research.