Trial · NCT02131662
Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap
NCT02131662, Phase 2, Completed, Bayer; results first posted 2017-12-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap. Trials, record NCT02131662. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02131662
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap
- NCT number
- NCT02131662
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 309 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Leiomyoma
- Interventions
- BAY1002670, BAY1002670, BAY1002670, BAY1002670, Placebo
- First posted
- 2014-05-06
- Last updated
- 2017-12-08
- Other registries' IDs
- eudract:2013-003945-40
- Results first posted
- 2017-12-08
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment | After end of the initial bleeding episode until the end of treatment, up to 12 weeks | Amenorrhea was defined as no scheduled or unscheduled bleeding/spotting after the end of the initial bleeding episode until end of treatment. Dose-response curve was estimated based on the primary endpoint. The 4 parameters characterizing the dose-response curve were reported in other pre-specified endpoints below. |
| Secondary | Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method) | From baseline to end of follow-up | In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint for each arm, respectively. |
| Secondary | Time to Onset of Controlled Bleeding | During treatment period | Onset of controlled bleeding was defined by the first day, for which the MBL (assessed by MP, Version 2014) for all subsequent 28-day periods up to the end of the treatment period was less than 80 mL. Kaplan-Meier estimated time to onset of controlled bleeding (days) was reported. |
| Secondary | Change in Volume of Largest Fibroid Compared to Baseline Measured by MRI | From baseline to end of follow-up period | Pelvic Magnetic resonance imagings (MRI), without contrast agents, were performed for volume measurements of the uterus and fibroids preferably using 1.5 Tesla scanners or higher. Images were sent to the imaging core laboratory for evaluation. Volume measurements of the uterus and fibroids were performed centrally by independent radiologist(s). |
| Other | Exposure-response Analysis of Vilaprisan - Percentage of Subjects Achieving Maximum Effect (Emax) of Induced Amenorrhea | From start of the study treatment to Day 84 (treatment period) | Maximum effect of vilaprisan on induced amenorrhea during treatment period. Induced amenorrhea was defined as number of subjects with amenorrhea (that is, all days with bleeding intensity 1 = none) , i.e. no bleeding or spotting allowed after initial bleeding episode until end of treatment. The nature of this exposure response analysis was the development of a model valid for the exposure response relationship over the entire range of available exposures (i.e. across all dose groups). Therefore, observations (exposure - induced amenorrhea) of all subjects need to be combined. |
| Other | Steady-state Exposure Achieving Half-maximal Effect (EAUC50) of Induced Amenorrhea During Treatment Period of Vilaprisan | From start of the study treatment to Day 84 (treatment period) | Area-under-the-curve (AUC) of vilaprisan between 0 and 24 hours post-dose at steady-state achieving 50% of maximum effect of vilaprisan on induced amenorrhea during treatment period. Induced amenorrhea was defined as number of subjects with induced-amenorrhea (that is, all days with bleeding intensity 1 = none) , i.e. no bleeding or spotting allowed after initial bleeding episode until end of treatment. The nature of this exposure response analysis was the development of a model valid for the exposure response relationship over the entire range of available exposures (i.e. across all dose groups). Therefore, observations (exposure - induced amenorrhea) of all subjects need to be combined. |
| Other | Exposure-response Analysis of Vilaprisan - Predicted Percentage of Subjects Below 90% of the Maximum Probability of Induced Amenorrhea | From start of the study treatment to Day 84 (treatment period) | The final exposure-response model was used to simulate the percentage of subjects below 90% of the maximum probability of induced amenorrhea (that is, all days with bleeding intensity 1 = none) for the selected doses 1, 2 and 3 mg (see table below). |
| Other | Assessment of MP to Identify Subjects With Heavy Menstrual Bleeding (HMB) | At baseline | The ability of the MP to identify subjects with HMB (defined as \> 80 mL of blood loss during bleeding episode) per 28 days against the the current gold standard (i.e. AH method) was assessed. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of MP method for detecting heavy menstrual bleeding were calculated against AH method. Sensitivity = true positive/(true positive + false negative)\*100; Specificity = true negative/(true negative + false positive)\*100; PPV = true positive/(true positive + false positive)\*100; NPV = true negative/(true negative + false negative)\*100. MP version 2014 was originally defined based on studies in healthy subjects. And MP version 2016 was developed for study population of women with heavy bleeding. |
| Other | Percentage of Subjects With Amenorrhea (Defined as MBL < 2 mL) During the Last 28 Days of Treatment | Last 28 Days of Treatment | |
| Other | Percentage of Subjects With HMB Response During the Last 28 Days of Treatment | Last 28 Days of Treatment |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment | After end of the initial bleeding episode until the end of treatment, up to 12 weeks | Percentage of subjects | NUMBER | |
| SECONDARY | Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method) | From baseline to end of follow-up | mL | MEAN | |
| SECONDARY | Time to Onset of Controlled Bleeding | During treatment period | Days | MEDIAN | |
| SECONDARY | Change in Volume of Largest Fibroid Compared to Baseline Measured by MRI | From baseline to end of follow-up period | mL | MEDIAN | |
| OTHER_PRE_SPECIFIED | Exposure-response Analysis of Vilaprisan - Percentage of Subjects Achieving Maximum Effect (Emax) of Induced Amenorrhea | From start of the study treatment to Day 84 (treatment period) | The exposure response analysis includes all verum treated subjects with valid PK concentration data and valid PD data and all placebo treated subjects with valid PD data (placebo: 50, 0.5 mg 50, 1.0 mg 56, 2.0 mg: 56, 4.0 mg: 55, in total 267). | Percentage of subjects | NUMBER |
| OTHER_PRE_SPECIFIED | Steady-state Exposure Achieving Half-maximal Effect (EAUC50) of Induced Amenorrhea During Treatment Period of Vilaprisan | From start of the study treatment to Day 84 (treatment period) | The exposure response analysis includes all verum treated subjects with valid PK concentration data and valid PD data and all placebo treated subjects with valid PD data (placebo: 50, 0.5 mg 50, 1.0 mg 56, 2.0 mg: 56, 4.0 mg: 55, in total 267). | mcg*h/L | NUMBER |
| OTHER_PRE_SPECIFIED | Exposure-response Analysis of Vilaprisan - Predicted Percentage of Subjects Below 90% of the Maximum Probability of Induced Amenorrhea | From start of the study treatment to Day 84 (treatment period) | Percentage of subjects | NUMBER | |
| OTHER_PRE_SPECIFIED | Assessment of MP to Identify Subjects With Heavy Menstrual Bleeding (HMB) | At baseline | An analysis set for the assessment of the interchangeability of the MP and the AH method to judge MBL included all screened subjects (except subjects in Japan) with any sanitary product data for which there is any matching pair of MP score and AH value available. A total of 399 subjects were included in this analysis set. | Percentage | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Subjects With Amenorrhea (Defined as MBL < 2 mL) During the Last 28 Days of Treatment | Last 28 Days of Treatment | Percentage of subjects | NUMBER | |
| OTHER_PRE_SPECIFIED | Percentage of Subjects With HMB Response During the Last 28 Days of Treatment | Last 28 Days of Treatment | Percentage of subjects | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment | VPR 4 mg | 60 | Percentage of subjects | ||
| Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment | VPR 2 mg | 54.1 | Percentage of subjects | ||
| Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment | VPR 1 mg | 55.7 | Percentage of subjects | ||
| Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment | VPR 0.5 mg | 30 | Percentage of subjects | ||
| Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment | Placebo | 1.7 | Percentage of subjects | ||
| Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method) | VPR 4 mg | 1st period (N=46, 46, 47, 45, 45) | -79.83 | Standard Deviation 234.22 | mL |
| Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method) | VPR 2 mg | 1st period (N=46, 46, 47, 45, 45) | -30.18 | Standard Deviation 106.82 | mL |
| Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method) | VPR 1 mg | 1st period (N=46, 46, 47, 45, 45) | -55.42 | Standard Deviation 109.29 | mL |
| Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method) | VPR 0.5 mg | 1st period (N=46, 46, 47, 45, 45) | -44.14 | Standard Deviation 110.61 | mL |
| Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method) | Placebo | 1st period (N=46, 46, 47, 45, 45) | 17.22 | Standard Deviation 124.14 | mL |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | VPR 4 mg | 62 | |
| Overall Study | STARTED | VPR 2 mg | 61 | |
| Overall Study | STARTED | VPR 1 mg | 63 | |
| Overall Study | STARTED | VPR 0.5 mg | 62 | |
| Overall Study | STARTED | Placebo | 61 | |
| Overall Study | Treated | VPR 4 mg | 60 | |
| Overall Study | Treated | VPR 2 mg | 61 | |
| Overall Study | Treated | VPR 1 mg | 61 | |
| Overall Study | Treated | VPR 0.5 mg | 60 | |
| Overall Study | Treated | Placebo | 58 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events160
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 | VPR 4 mg | 3 | 60 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | VPR 2 mg | 3 | 61 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | VPR 1 mg | 3 | 61 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | VPR 0.5 mg | 2 | 60 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 5 | 58 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | VPR 4 mg | 4 | 60 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | VPR 2 mg | 0 | 61 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | VPR 1 mg | 1 | 61 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | VPR 0.5 mg | 0 | 60 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 3 | 58 | 3 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | VPR 4 mg | ||
| Total, all-cause mortality | VPR 2 mg | ||
| Total, all-cause mortality | VPR 1 mg | ||
| Total, all-cause mortality | VPR 0.5 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | VPR 4 mg | 31 | 60 |
| Total, other adverse events | VPR 2 mg | 30 | 61 |
| Total, other adverse events | VPR 1 mg | 31 | 61 |
| Total, other adverse events | VPR 0.5 mg | 32 | 60 |
| Total, other adverse events | Placebo | 32 | 58 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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
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GET https://conductscience.org/api/trials/v1/NCT02131662/results?page=2