Ulipristal Acetate for the Preoperative Management of Hypoechoic Cellular Leiomyomas

What Was Tested

This registered phase 4 trial tested Leuprolide for cellulite.

Hypoechoic CLs should be more responsive to ulipristal acetate treatment than common leiomyomas.

It had two arms (groups): Ulipristal acetate (experimental) and Leuprolile acetate (active comparator).

The registry classes the interventions as drug.

More on the Plan

They are histologically composed by smooth muscle cells with bland, uniform, cigar-shaped nuclei that are arranged in interlacing bundles, showing little or no mitotic activity.

The presenting symptoms do not differ from those of patients with typical leiomyomas.

On gross examination, CLs are more often soft and appear more tan or yellow and less circumscribed than the usual leiomyomas.

Pre-operatively, anyway, CLs can be recognized at ultrasound evaluation because they appear as hypoechoic uterine lesions.

Who Took Part

The registry lists 42 planned participants were the target.

It was open to women only aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Hypoechoic uterine leiomyoma (echogenicity \<3),. Intramural leiomyomas with an ultrasonographic size \<20 cm but \>4cm,. Indication to surgery (symptoms of menometrorrhagia,. Pelvic pain or pelvic pressure.

The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: submucosal leiomyoma,; endometrial hyperplasia with atypia,; history of uterine surgery.

How the Study Was Run

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

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

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

As a double-blind Leuprolide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2015-02 with completion listed for 2017-09.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Operative time (minutes) (time frame: At the time of skin closure at the end of the myomectomy).

It also tracked 3 secondary outcomes, for example Difficulty of leiomyoma enucleation assessed by surgeon on a VAS scale, Intraoperative blood loss (delta Hb) and Post-operative evaluation of leiomyomas characteristics.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide in 42 people with cellulite.

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

More context: the Leuprolide compound page, Cellulite research.