Study of the Efficacy of Dienogest in the Treatment of Uterine Leiomyomas When Compared to Desogestrel and Goserelin

What Was Tested

The trial (phase 4) is built around Goserelin.

It had three arms (groups): Dienogest (experimental), Goserelin (experimental) and Desogestrel (active comparator).

The registry classes the interventions as drug.

More on the Plan

Uterine leiomyoma is a very prevalent condition among women and, although it is mainly asymptomatic, it may be related to bothersome or debilitating symptoms, such as uterine bleeding and pelvic pain or pressure.

The standard treatment is surgical (hysterectomy or myomectomy), but there has been continued interest on medical treatments.

Who Took Part

14 actual participants took part.

It was open to women only aged from 35 years up to 55 years.

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

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: liver or kidney dysfunction; women with only submucosal or subserosal uterine leiomyomas; women with contraindications to any of the drugs (categories 3 and 4 of who eligibility criteria).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Goserelin group and the comparison group should start out alike.

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

Everyone knew when Goserelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2012-01 with completion listed for 2016-12.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Leiomyoma Volume (time frame: After 6 months of medical therapy).

It also tracked 2 secondary outcomes, for example Number of episodes of vaginal bleeding.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Goserelin in 14 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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