A Phase 3 interventional study of Vilaprisan (BAY1002670) and Placebo in Uterine Fibroids, sponsored by Bayer. Terminated at 103 sites in 9 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-03.
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 7th largest by enrollment, is one of 5 that started in 2018, is one of 6 in phase 3, and was the 8th 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 93 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 7th largest by enrollment, is one of 5 that started in 2018, is one of 6 in phase 3, and was the 8th 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.
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The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.
The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Drug: Vilaprisan (BAY1002670) · Drug: Placebo
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
Drug: Vilaprisan (BAY1002670)
Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Drug: Vilaprisan (BAY1002670) · Drug: Placebo
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Drug: Vilaprisan (BAY1002670) · Drug: Placebo
2 mg of Vilaprisan once daily up to 2 x 12 weeks
Matching placebo was administered to group B1 and B2.
Number of Participants With Amenorrhea
Amenorrhea was defined as menstrual blood loss (MBL) \<2 mL during the last 28 days of treatment measured by the alkaline hematin (AH) method.
Time frame: The last 28 days of treatment period 1
Number of Participants With Heavy Menstrual Bleeding (HMB) Response
HMB response was defined as MBL \<80 mL during the last 28 days of treatment and \>50% reduction from baseline based on AH-method.
Time frame: The last 28 days of treatment period 1 and treatment period 2
Time to Onset of Amenorrhea
Onset of amenorrhea was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was \< 2 mL (amenorrhea defined similar to primary endpoint).
Time frame: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Time to Onset of Controlled Bleeding
Onset of controlled bleeding was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was \<80.00 mL based on AH-method.
Time frame: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Number of Participants With Absence of Bleeding (Spotting Allowed)
Absence of bleeding was defined as no scheduled or unscheduled bleeding (spotting allowed) during the last 28 days of a treatment period based on subjects' daily responses to the Uterine Fibroid Daily Bleeding Diary (UF-DBD).
Time frame: The last 28 days of treatment period 1 and treatment period 2
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Number of participants with endometrial histology findings, e.g. benign endometrium, Malignant Neoplasm, Hyperplasia WHO 2014, no atypia or Hyperplasia WHO 2014, atypia and Endometrial Polyps.
Time frame: Up to 2 weeks after end of treatment
Change From Baseline of Endometrial Thickness
Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline in endometrial thickness was provided in below table.
Time frame: Treatment phase (up to 2 weeks after end of treatment) and follow-up phase (starts on the day after the end of the treatment until the last study visit [up to approximately 2 years])
The study was conducted at 104 study centers in 9 countries worldwide between 17-Jan-2018 (first participant first visit) and 06-Apr- 2022 (last participant last visit).
| Milestone | Vilaprisan (A1) | Vilaprisan (A2) | Placebo+Vilaprisan (B1) | Vilaprisan+Placebo (B2) |
|---|---|---|---|---|
| Started | 23 | 23 | 24 | 23 |
| Treated | 18 | 21 | 20 | 20 |
| Completed | 18 | 21 | 18 | 18 |
| Not completed | 5 | 2 | 6 | 5 |
| Withdrew: Adverse event | 0 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 1 | 0 |
| Withdrew: Study terminated by sponsor | 2 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 3 | 1 |
| Withdrew: Other | 2 | 1 | 2 | 2 |
| Milestone | Vilaprisan (A1) | Vilaprisan (A2) | Placebo+Vilaprisan (B1) | Vilaprisan+Placebo (B2) |
|---|---|---|---|---|
| Started | 18 | 0 | 18 | 18 |
| Completed | 7 | 0 | 7 | 5 |
| Not completed | 11 | 0 | 11 | 13 |
| Withdrew: Adverse event | 2 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 |
| Withdrew: Study terminated by sponsor | 5 | 0 | 5 | 6 |
| Withdrew: Withdrawal by subject | 1 | 0 | 2 | 2 |
| Withdrew: Other | 2 | 0 | 4 | 5 |
| Milestone | Vilaprisan (A1) | Vilaprisan (A2) | Placebo+Vilaprisan (B1) | Vilaprisan+Placebo (B2) |
|---|---|---|---|---|
| Started | 7 | 21 | 7 | 5 |
| Completed | 6 | 13 | 7 | 5 |
| Not completed | 1 | 8 | 0 | 0 |
| Withdrew: Study terminated by sponsor | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 |
| Withdrew: Other | 1 | 6 | 0 | 0 |
| Milestone | Vilaprisan (A1) | Vilaprisan (A2) | Placebo+Vilaprisan (B1) | Vilaprisan+Placebo (B2) |
|---|---|---|---|---|
| Started | 7 | 15 | 7 | 5 |
| Completed | 6 | 15 | 7 | 5 |
| Not completed | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 |
Amenorrhea was defined as menstrual blood loss (MBL) \<2 mL during the last 28 days of treatment measured by the alkaline hematin (AH) method.
| Participants | Vilaprisan (A1) | Vilaprisan (A2) | Placebo+Vilaprisan (B1) | Vilaprisan+Placebo (B2) |
|---|---|---|---|---|
| Number of Participants With Amenorrhea | 16 | 20 | 4 | 15 |
HMB response was defined as MBL \<80 mL during the last 28 days of treatment and \>50% reduction from baseline based on AH-method.
| Participants | Vilaprisan (A1) | Vilaprisan (A2) | Placebo+Vilaprisan (B1) | Vilaprisan+Placebo (B2) |
|---|---|---|---|---|
| Treatment period 1 | 17 | 20 | 8 | 17 |
| Treatment period 2 | 6 | 14 | 6 | 1 |
Onset of amenorrhea was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was \< 2 mL (amenorrhea defined similar to primary endpoint).
| Days | Vilaprisan (A1) | Vilaprisan (A2) | Placebo+Vilaprisan (B1) | Vilaprisan+Placebo (B2) |
|---|---|---|---|---|
| Treatment Period 1 | 3 (2 to 4) | NA (NA to NA) | NA (NA to NA) | 6 (1 to 46) |
| Treatment Period 2 | 21 (2 to 32) | NA (NA to NA) | 2 (1 to NA) | NA (NA to NA) |
| Treatment periods 1 and 2 combined | NA (NA to NA) | 9 (3 to 107) | NA (NA to NA) | NA (NA to NA) |
Onset of controlled bleeding was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was \<80.00 mL based on AH-method.
| Days | Vilaprisan (A1) | Vilaprisan (A2) | Placebo+Vilaprisan (B1) | Vilaprisan+Placebo (B2) |
|---|---|---|---|---|
| Treatment period 1 | 1 (1 to 2) | NA (NA to NA) | NA (53 to NA) | 1 (1 to 1) |
| Treatment period 2 | 1 (1 to 1) | NA (NA to NA) | 1 (1 to 2) | NA (NA to NA) |
| Treatment periods 1 and 2 combined | NA (NA to NA) | 1 (1 to 7) | NA (NA to NA) | NA (NA to NA) |
Absence of bleeding was defined as no scheduled or unscheduled bleeding (spotting allowed) during the last 28 days of a treatment period based on subjects' daily responses to the Uterine Fibroid Daily Bleeding Diary (UF-DBD).
| Participants | Vilaprisan (A1) | Vilaprisan (A2) | Placebo+Vilaprisan (B1) | Vilaprisan+Placebo (B2) |
|---|---|---|---|---|
| Treatment period 1 | 16 | 20 | 4 | 15 |
| Treatment period 2 | 6 | 13 | 6 | 0 |
Number of participants with endometrial histology findings, e.g. benign endometrium, Malignant Neoplasm, Hyperplasia WHO 2014, no atypia or Hyperplasia WHO 2014, atypia and Endometrial Polyps.
| Participants | Vilaprisan (A1) | Vilaprisan (A2) | Placebo+Vilaprisan (B1) | Vilaprisan+Placebo (B2) |
|---|---|---|---|---|
| Benign Endometrium | 17 | 20 | 17 | 22 |
| Hyperplasia WHO 2014, no atypia | 0 | 0 | 0 | 0 |
| Hyperplasia WHO 2014, atypia | 1 | 0 | 0 | 0 |
| Malignant Neoplasm | 0 | 0 | 0 | 0 |
| Endometrial Polyps | 1 | 1 | 1 | 0 |
Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline in endometrial thickness was provided in below table.
| Millimeters | Vilaprisan (A1) | Vilaprisan (A2) | Placebo+Vilaprisan (B1) | Vilaprisan+Placebo (B2) |
|---|---|---|---|---|
| Treatment phase | -2.2 ± 3.0 | -1.3 ± 4.3 | -1.8 ± 4.9 | -1.8 ± 3.4 |
| Follow-up phase | -3.0 ± 4.6 | -0.5 ± 3.8 | -3.1 ± 4.0 | -1.8 ± 3.7 |
Collected over For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vilaprisan - Treatment Emergent AEs | 0/69 (0%) | 2/69 (2.9%) | 30/69 (43.5%) |
| Placebo - Treatment Emergent AEs | 0/22 (0%) | 1/22 (4.5%) | 8/22 (36.4%) |
| Vilaprisan (A1) - Post Treatment AEs | 0/18 (0%) | 3/18 (16.7%) | 9/18 (50%) |
| Vilaprisan (A2) - Post Treatment AEs | 0/21 (0%) | 6/21 (28.6%) | 4/21 (19%) |
| Placebo+ Vilaprisan (B1) - Post Treatment AEs | 0/17 (0%) | 3/17 (17.6%) | 6/17 (35.3%) |
| Vilaprisan+ Placebo (B2) - Post Treatment AEs | 0/23 (0%) | 6/23 (26.1%) | 7/23 (30.4%) |
| Event | Vilaprisan - Treatment Emergent AEs | Placebo - Treatment Emergent AEs | Vilaprisan (A1) - Post Treatment AEs | Vilaprisan (A2) - Post Treatment AEs | Placebo+ Vilaprisan (B1) - Post Treatment AEs | Vilaprisan+ Placebo (B2) - Post Treatment AEs |
|---|---|---|---|---|---|---|
| MyomectomySurgical and medical procedures | 0/69 | 0/22 | 0/18 | 0/21 | 2/17 | 1/23 |
| Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/69 | 0/22 | 1/18 | 2/21 | 0/17 | 1/23 |
| HysterectomySurgical and medical procedures | 0/69 | 0/22 | 0/18 | 0/21 | 1/17 | 2/23 |
| CystoscopyInvestigations | 0/69 | 0/22 | 0/18 | 0/21 | 1/17 | 0/23 |
| SalpingectomySurgical and medical procedures | 0/69 | 0/22 | 0/18 | 0/21 | 1/17 | 0/23 |
| Endometrial hyperplasiaReproductive system and breast disorders | 0/69 | 0/22 | 1/18 | 0/21 | 0/17 | 0/23 |
| Abnormal uterine bleedingReproductive system and breast disorders | 0/69 | 0/22 | 1/18 | 0/21 | 0/17 | 0/23 |
| AnaemiaBlood and lymphatic system disorders | 0/69 | 0/22 | 0/18 | 1/21 | 0/17 | 0/23 |
| Spinal osteoarthritisMusculoskeletal and connective tissue disorders | 0/69 | 0/22 | 0/18 | 1/21 | 0/17 | 0/23 |
| Papillary thyroid cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/69 | 0/22 | 0/18 | 1/21 | 0/17 | 0/23 |
| Event | Vilaprisan - Treatment Emergent AEs | Placebo - Treatment Emergent AEs | Vilaprisan (A1) - Post Treatment AEs | Vilaprisan (A2) - Post Treatment AEs | Placebo+ Vilaprisan (B1) - Post Treatment AEs | Vilaprisan+ Placebo (B2) - Post Treatment AEs |
|---|---|---|---|---|---|---|
| Vitamin D deficiencyMetabolism and nutrition disorders | 0/69 | 0/22 | 5/18 | 1/21 | 1/17 | 1/23 |
| Abdominal painGastrointestinal disorders | 4/69 | 5/22 | 0/18 | 1/21 | 0/17 | 1/23 |
| AnaemiaBlood and lymphatic system disorders | 0/69 | 4/22 | 4/18 | 2/21 | 0/17 | 3/23 |
| NauseaGastrointestinal disorders | 9/69 | 3/22 | 0/18 | 0/21 | 1/17 | 0/23 |
| FatigueGeneral disorders | 4/69 | 3/22 | 0/18 | 0/21 | 0/17 | 0/23 |
| HeadacheNervous system disorders | 9/69 | 0/22 | 0/18 | 0/21 | 0/17 | 2/23 |
| Heavy menstrual bleedingReproductive system and breast disorders | 0/69 | 1/22 | 2/18 | 1/21 | 0/17 | 0/23 |
| Blood testosterone increasedInvestigations | 0/69 | 0/22 | 0/18 | 0/21 | 0/17 | 2/23 |
| Hot flushVascular disorders | 6/69 | 0/22 | 0/18 | 0/21 | 0/17 | 0/23 |
| Upper respiratory tract infectionInfections and infestations | 5/69 | 0/22 | 0/18 | 0/21 | 0/17 | 1/23 |
SAF consisted of all randomized participants in FAS who took at least 1 dose of study drug. The discrepancy of group B1 and B2 between subject dispostion and baseline characteristics was caused by mistakes in the administration of study drug. Three participants who were assigned to B1, erroneously received vilaprisan treatment instead of placebo in Treatment Period (TP) 1. Two participants who were assigned to B1, erroneously received placebo instead of vilaprisan in TP2.
| Age, Continuous(Years) | Vilaprisan (A1) | Vilaprisan (A2) | Placebo+Vilaprisan (B1) | Vilaprisan+Placebo (B2) | Total |
|---|---|---|---|---|---|
| Mean | 43.1 ± 4.4 | 43.1 ± 5.8 | 42.5 ± 5.3 | 43.8 ± 5.1 | 43.2 ± 5.1 |
| Sex: Female, Male(Participants) | Vilaprisan (A1) | Vilaprisan (A2) | Placebo+Vilaprisan (B1) | Vilaprisan+Placebo (B2) | Total |
|---|---|---|---|---|---|
| Female | 18 | 21 | 17 | 23 | 79 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Vilaprisan (A1) | Vilaprisan (A2) | Placebo+Vilaprisan (B1) | Vilaprisan+Placebo (B2) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 4 | 1 | 1 | 0 | 6 |
| Not Hispanic or Latino | 13 | 20 | 16 | 22 | 71 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Vilaprisan (A1) | Vilaprisan (A2) | Placebo+Vilaprisan (B1) | Vilaprisan+Placebo (B2) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 5 | 8 | 5 | 7 | 25 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 6 | 5 | 7 | 11 | 29 |
| White | 7 | 6 | 5 | 5 | 23 |
| More than one race | 0 | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 1 |
| Endometrial thickness(Millimeters) | Vilaprisan (A1) | Vilaprisan (A2) | Placebo+Vilaprisan (B1) | Vilaprisan+Placebo (B2) | Total |
|---|---|---|---|---|---|
| Mean | 13.6 ± 7.6 | 11.0 ± 5.4 | 11.9 ± 6.5 | 10.5 ± 3.9 | 11.7 ± 5.9 |
Showing the first 100 of 103 sites across 9 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint 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.vivli.org 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 member section of the portal.
Ran from Jan 2018 to primary completion in Jun 2019, 16 months.
Results were first posted in Jun 2021, 2 years after primary completion. A results delay was requested in Mar 2020.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vilaprisan