Gonadotropin-releasing Hormone Agonist Prior to Myomectomy

What Was Tested

In this phase 3 trial, researchers set out to test Goserelin.

It had three arms (groups): No Treatment (Control) (no intervention), one (experimental) and one (experimental).

Women were randomised to receive no gonadotropin-releasing hormone agonist prior to myomectomy.

The registry classes the interventions as drug.

More on the Plan

Variables noted preoperatively: * Age * Parity * Ethnicity * Ultrasound findings Variables noted intra-operatively: * Size of largest fibroid * Estimated blood loss.

Who Took Part

68 actual participants took part.

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: Women between the age of 20 and 45. Presence of regular menstrual cycles. Ultrasound confirmation of fibroids. Normal cervical smear.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: presence of endometriosis previous myomectomy ovarian, uterine or cervical malignancy female factor for subfertility.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

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

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

In this single-blind Goserelin study one party knew the assignments and the other did not.

Those kept unaware of assignments: care provider.

It started in 2008-01 with completion listed for 2011-12.

It ran at 1 site in Trinidad and Tobago.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Intraoperative blood loss (time frame: 3 months).

It also tracked 4 secondary outcomes, for example Blood transfusion requirement, The level of difficulty in enucleation of the fibroid and in achieving hemostasis and Length of operation.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 68 people.

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

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