A Phase 3 interventional study of Vilaprisan (BAY1002670) in Uterine Fibroids and Heavy Menstrual Bleeding, sponsored by Bayer. Terminated at 25 sites in Japan. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-08.
Sponsored by Bayer · Phase 3, Interventional, and Treatment
Among 12 studies testing vilaprisan in Leiomyoma — none open to participants now, none under way, none of them phase 3. vilaprisan · Leiomyoma.
Among the 12 studies testing vilaprisan in Leiomyoma, this one is the 4th largest by enrollment, is one of 5 that started in 2018, is one of 6 in phase 3, and was the 11th registered.
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
Browse Leiomyoma studies →None of the 12 studies testing vilaprisan in Leiomyoma is open now. The open studies under Leiomyoma, anywhere →
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 43 Leiomyoma studies recruiting now, 21 (49%) set no upper age limit and 21 (49%) stop at 75 or younger; 3 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 5 started in 2018.
This study's enrollment of 153 is above the median of 66 across 306 interventional studies indexed under Leiomyoma.
Median enrollment 98 across the 12 interventional studies. Of the 11 that completed or were terminated, 4 (36%) have results posted.
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12 of 12 have an industry lead sponsor. The 1 most frequent:
Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
12 studies in Leiomyoma by Bayer: none open now, none under way, none of them phase 3. Of 11 finished, 4 (36%) have results posted.
Among the 12 studies in Leiomyoma by Bayer, this one is the 4th largest by enrollment, is one of 5 that started in 2018, is one of 6 in phase 3, and was the 11th registered.
Bayer’s Leiomyoma studies by the year they started, since 2011.
None of the studies under way reaches primary completion within a year.
Among the 12 studies testing vilaprisan in Leiomyoma, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Bayer’s 12 in Leiomyoma:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
4 treatment periods of 12 weeks, each separated by 1 bleeding episode
Drug: Vilaprisan (BAY1002670)
2 treatment periods of 24 weeks, separated by 2 bleeding episodes
Drug: Vilaprisan (BAY1002670)
2mg, once daily, oral
Incidence of treatment-emergent adverse event
Time frame: Up to one year and 3 months
Number of bleeding days
Time frame: Up to one year and 3 months
Plan to share: Undecided — Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Ran from Mar 2018 to primary completion in Jul 2021, 39 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vilaprisan