Randomized Study of Gonadotropin-releasing-hormone Agonist (GnRH-a) or Expectant Management for Endometriosis

What Was Tested

The trial (phase 4) is built around Goserelin for endometriosis.

The purpose of this study is to identify the recurrent rate and pregnancy rate of advanced endometriosis after laparoscopic surgery plus GnRHa goserelin acetate treatment.

It had two arms (groups): 1 (experimental) and 2 (no intervention).

The registry classes the interventions as drug.

More on the Plan

Data on the short-term recurrence of advanced endometriosis is rare.

Who Took Part

Enrollment: 60 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: Age \>=18 years old. Normal menstruation for 3 months before enrollment (25-35 days）. Advanced endometriosis confirmed histologically (r-AFS score III-IV) with laparoscopy or laparotomy-pelvic pain and/or dysmenorrhea and/or dyspareunia. Agreement on the strict follow-up plan. Without previous hormonal treatment.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: serious heart diseases/pulmonary/liver/kidney diseases; previous non-endometriosis relevant surgery possibly influence to abdominal or pelvic pain; suspected malignancy in endometriosis.

How the Study Was Run

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

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

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

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

It started in 2008-03 with completion listed for 2009-12.

It ran at 1 site in China.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): The recurrent rate of advanced endometriosis (time frame: within one year after surgery or GnRH-a management).

It also tracked 1 secondary outcome, for example The pregnancy rate following laparoscopic surgery for advanced endometriosis.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Goserelin in 60 people with endometriosis.

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

More context: the Goserelin compound page, Endometriosis research.