Trial · NCT03194646
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
NCT03194646, Phase 3, Terminated, Bayer; results first posted 2021-08-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids. Trials, record NCT03194646. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03194646
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
- NCT number
- NCT03194646
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,272 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Uterine Fibroids
- Interventions
- Vilaprisan (BAY1002670), Vilaprisan (BAY1002670), Vilaprisan (BAY1002670), Standard of care, Vilaprisan (BAY1002670), Vilaprisan (BAY1002670), Vilaprisan (BAY1002670)
- First posted
- 2017-06-21
- Last updated
- 2025-07-28
- Other registries' IDs
- eudract:2016-004822-41
- Results first posted
- 2021-08-26
- Limitations and caveats
This study was ended prematurely. On top of the data included in the previous summary of results after primary completion, this final summary of results adds adverse event data from long term follow-up of subjects in Turkey as per local requirements. This was to ensure follow-up of all Turkish subjects for 5 years after end of study medication intake.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine | From baseline to about 1 year after start of treatment | The percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine from baseline to about one year after start of treatment (SoT) in all randomized and treated participants with measurements at those 2 time points in each treatment group. |
| Secondary | Number of Bleeding Days | Treatment phase: approximately 1 year | Number of bleeding days were defined from Day 1 of the first treatment period until the day before a new treatment period would start again following the last treatment period for that respective treatment group. Number to be normalized by 28 days |
| Secondary | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Up to 3 years (from study treatment start to end of study) | Number of participants with endometrial histology findings, e.g. benign endometrium, presence or absence of hyperplasia or malignancy |
| Secondary | Change From Baseline in Endometrial Thickness | Treatment phase: approximately 1 year, follow-up phase: up to 2 years | Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline (worst measurement during baseline period) in endometrial thickness was provided in below table. |
| Secondary | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Treatment phase: approximately 1 year, follow-up phase: up to 2 years | Percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine (other time points not mentioned as primary safety analysis), hip, and femoral neck from baseline was analyzed using the same statistical methods as used for the primary variable. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine | From baseline to about 1 year after start of treatment | Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Overall number of participants analyzed represents number of participants without missing data. | Percentage change | MEAN |
| SECONDARY | Number of Bleeding Days | Treatment phase: approximately 1 year | FAS was analyzed. | Days | MEAN |
| SECONDARY | Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Up to 3 years (from study treatment start to end of study) | SAF was analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Endometrial Thickness | Treatment phase: approximately 1 year, follow-up phase: up to 2 years | SAF was analyzed. | Millimeters | MEAN |
| SECONDARY | Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck | Treatment phase: approximately 1 year, follow-up phase: up to 2 years | SAF was analyzed. Percentage change from baseline in BMD of lumbar spine, hip and femoral neck was presented by time interval in below table. | Percentage change | MEAN |
Source ClinicalTrials.gov
Results by group112
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine | Vilaprisan 2 mg A1 (3/1 Regimen) | -1.56 | Standard Deviation 2.72 | Percentage change | |
| Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine | Vilaprisan 2 mg A2 (6/2 Regimen) | -2.04 | Standard Deviation 2.50 | Percentage change | |
| Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine | Vilaprisan 2 mg A3 (3/2 Regimen) | -1.51 | Standard Deviation 2.28 | Percentage change | |
| Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine | B (Standard of Care) | 0.29 | Standard Deviation 2.36 | Percentage change | |
| Number of Bleeding Days | Vilaprisan 2 mg A1 (3/1 Regimen) | 1.57 | Standard Deviation 1.99 | Days | |
| Number of Bleeding Days | Vilaprisan 2 mg A2 (6/2 Regimen) | 1.74 | Standard Deviation 2.52 | Days | |
| Number of Bleeding Days | Vilaprisan 2 mg A3 (3/2 Regimen) | 1.81 | Standard Deviation 1.24 | Days | |
| Number of Bleeding Days | B (Standard of Care) | 4.72 | Standard Deviation 4.60 | Days | |
| Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Vilaprisan 2 mg A1 (3/1 Regimen) | Adequate endometrial tissue | 346 | Participants | |
| Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) | Vilaprisan 2 mg A2 (6/2 Regimen) | Adequate endometrial tissue | 346 | Participants |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vilaprisan 2 mg A1 (3/1 Regimen) | 363 | |
| Overall Study | STARTED | Vilaprisan 2 mg A2 (6/2 Regimen) | 361 | |
| Overall Study | STARTED | Vilaprisan 2 mg A3 (3/2 Regimen) | 183 | |
| Overall Study | STARTED | B (Standard of Care) | 365 | |
| Overall Study | Treated | Vilaprisan 2 mg A1 (3/1 Regimen) | 349 | |
| Overall Study | Treated | Vilaprisan 2 mg A2 (6/2 Regimen) | 347 | |
| Overall Study | Treated | Vilaprisan 2 mg A3 (3/2 Regimen) | 177 | |
| Overall Study | Treated | B (Standard of Care) | 365 | |
| Overall Study | COMPLETED | Vilaprisan 2 mg A1 (3/1 Regimen) | 59 | |
| Overall Study | COMPLETED | Vilaprisan 2 mg A2 (6/2 Regimen) | 93 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events2,008
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Vilaprisan 2 mg A1 (3/1 Regimen) - Treatment Emergent AEs | 4 | 349 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Vilaprisan 2 mg A2 (6/2 Regimen) - Treatment Emergent AEs | 8 | 347 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Vilaprisan 2 mg A3 (3/2 Regimen) - Treatment Emergent AEs | 3 | 177 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Standard of Care B - Treatment Emergent AEs | 29 | 365 | 30 |
| other | Anaemia | Blood and lymphatic system disorders | Vilaprisan 2 mg A1 (3/1 Regimen) - Post Treatment AEs | 10 | 349 | 10 |
| other | Anaemia | Blood and lymphatic system disorders | Vilaprisan 2 mg A2 (6/2 Regimen) - Post Treatment AEs | 12 | 347 | 12 |
| other | Anaemia | Blood and lymphatic system disorders | Vilaprisan 2 mg A3 (3/2 Regimen) - Post Treatment AEs | 8 | 177 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Standard of Care B - Post Treatment AEs | 1 | 365 | 1 |
| other | Fatigue | General disorders | Vilaprisan 2 mg A1 (3/1 Regimen) - Treatment Emergent AEs | 13 | 349 | 13 |
| other | Fatigue | General disorders | Vilaprisan 2 mg A2 (6/2 Regimen) - Treatment Emergent AEs | 20 | 347 | 20 |
1 to 10 of 2,008Source ClinicalTrials.gov
See all 2,008 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vilaprisan 2 mg A1 (3/1 Regimen) - Treatment Emergent AEs | 0 | 349 |
| Total, all-cause mortality | Vilaprisan 2 mg A2 (6/2 Regimen) - Treatment Emergent AEs | 0 | 347 |
| Total, all-cause mortality | Vilaprisan 2 mg A3 (3/2 Regimen) - Treatment Emergent AEs | 0 | 177 |
| Total, all-cause mortality | Standard of Care B - Treatment Emergent AEs | 0 | 365 |
| Total, all-cause mortality | Vilaprisan 2 mg A1 (3/1 Regimen) - Post Treatment AEs | 0 | 349 |
| Total, all-cause mortality | Vilaprisan 2 mg A2 (6/2 Regimen) - Post Treatment AEs | 0 | 347 |
| Total, all-cause mortality | Vilaprisan 2 mg A3 (3/2 Regimen) - Post Treatment AEs | 0 | 177 |
| Total, all-cause mortality | Standard of Care B - Post Treatment AEs | 0 | 365 |
| Total, other adverse events | Vilaprisan 2 mg A1 (3/1 Regimen) - Treatment Emergent AEs | 136 | 349 |
| Total, other adverse events | Vilaprisan 2 mg A2 (6/2 Regimen) - Treatment Emergent AEs | 152 | 347 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03194646
GET https://conductscience.org/api/trials/v1/NCT03194646/results?page=2