To Prevent Type I-II Myoma After TCRM Recurrence by Gonadotropin-releasing Hormone (GnRH )Analogues or Mifepristone

What Was Tested

This registered not phased trial tested Goserelin.

It had three arms (groups): GnRHa group (experimental), mifepristone group (experimental) and control group (no intervention).

Patients with fibroid remained will be enrolled and the third group was serviced as controls and no drugs will be used.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 294 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Age more than 18 years and less than 45 years old, no childbirth requirements in the next 3 years;. Type I and II submucosal fibroids diagnosed by ultrasound, and the diameter of them are greater than 3cm;. Type I or II submucosal fibroids confirmed by TCRM and no degeneration confirmed pathologically;. A MRI test will be done to evaluate the residual submucosal fibroids and calculate the residual fibroid volume after 1 month of surgery;. Patients would not had used drugs such as mifepristone and GnRHa 3 months before surgery;.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: combined with congenital uterine malformations such as double uterus, unicornuate uterus, etc;; have fertility requirements within 3 years after surgery;; estrogen-dependent diseases such as adenomyosis and endometriosis;.

How the Study Was Run

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

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

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

It started in 2023-06-01 with completion listed for 2024-12-30.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: the remaining submucous fibroids volume (time frame: one to three years after TCRM).

It also tracked 2 secondary outcomes, for example the recurrence rate of remaining submucous fibroids and time and the recurrence time of remaining submucous fibroids.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Goserelin in 294 people.

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

More context: the Goserelin compound page, all human trials.