Bayer has started patient enrolment for a Phase III ASTEROID clinical trial of vilaprisan to treat patients with uterine fibroids in the US.

Vilaprisan is an oral, selective progesterone receptor modulator (SPRM) being developed to bind to the receptor of progesterone hormone and alter its activity.

The open-label, parallel-group, randomised, multi-centre Phase III trial is designed to evaluate the safety and efficacy of 2mg of vilaprisan for the treatment of symptomatic uterine fibroids, in comparison to standard of care.

The firm plans to screen a total of more than 1,400 women and enrol 750 subjects at around 240 centres in the country.

"The initiation of this trial reinforces our ongoing commitment to finding innovative solutions for women suffering from gynaecological conditions."

Bayer Americas medical affairs senior vice-president and head Dario Mirski said: “Bayer has a rich legacy in women's health research, and we are dedicated to investigating vilaprisan as a potential medical treatment option for women with symptomatic uterine fibroid.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

"The initiation of this trial reinforces our ongoing commitment to finding innovative solutions for women suffering from gynaecological conditions."

Expected to be completed in November 2021, the primary outcome measure of the trial is percentage lumbar spine bone mineral density (BMD) change from baseline to approximately one year from the start of treatment (SoT).

Additional efficacy measures such as the effect of vilaprisan on heavy menstrual bleeding, including amenorrhea rate and controlled bleeding, and a decrease in fibroid size will also be assessed during the trial.


Image: A small uterine fibroid as seen on ultrasound. Photo: courtesy of James Heilman.

Clinical Trials Arena Excellence Awards - Have you nominated?

Nominations are now open for the prestigious Clinical Trials Arena Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact. This is your chance to showcase your achievements, highlight industry advancements, and gain global recognition. Don't miss the opportunity to be honoured among the best - submit your nomination today!

Nominate Now