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Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap (ASTEROID 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02131662
Recruitment Status : Completed
First Posted : May 6, 2014
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Leiomyoma
Interventions Drug: BAY1002670
Drug: Placebo
Enrollment 309
Recruitment Details The study was conducted at multiple centers in 12 countries worldwide between 15 May 2014 (first subject first visit) and 04 May 2016 (last subject last visit).
Pre-assignment Details 748 subjects were screened; 439 subjects were not randomized, the majority was screen failures. Therefore, 309 subjects were randomized.
Arm/Group Title VPR 4 mg VPR 2 mg VPR 1 mg VPR 0.5 mg Placebo
Hide Arm/Group Description Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Period Title: Overall Study
Started 62 61 63 62 61
Treated 60 61 61 60 58
Completed Treatment 57 60 61 56 52
Completed Follow-up 54 47 56 42 44
Completed 54 47 56 41 43
Not Completed 8 14 7 21 18
Reason Not Completed
Protocol Violation             1             0             0             0             0
Other             2             4             3             3             4
Adverse Event             0             1             1             1             3
Pregnancy             0             1             0             1             0
Wish for pregnancy             0             0             0             0             1
Lack of Efficacy             1             0             0             0             1
Withdrawal by Subject             1             5             1             5             6
Lost to Follow-up             1             3             0             9             0
Not treated             2             0             2             2             3
Arm/Group Title VPR 4 mg VPR 2 mg VPR 1 mg VPR 0.5 mg Placebo Total
Hide Arm/Group Description Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. Total of all reporting groups
Overall Number of Baseline Participants 60 61 61 60 58 300
Hide Baseline Analysis Population Description
Baseline characteristics is reported for the Full Analysis Set/Safety Analysis Set (including all subjects who took at least 1 dose of study drug)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 61 participants 61 participants 60 participants 58 participants 300 participants
43.5  (4.2) 43  (4.6) 41.9  (4.5) 41.7  (4.9) 42.8  (5.1) 42.6  (4.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 61 participants 61 participants 60 participants 58 participants 300 participants
Female
60
 100.0%
61
 100.0%
61
 100.0%
60
 100.0%
58
 100.0%
300
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Baseline menstrual blood loss by MP  
Mean (Standard Deviation)
Unit of measure:  Millilitre(s)
Number Analyzed 60 participants 61 participants 61 participants 60 participants 58 participants 300 participants
172.3  (111.86) 176.9  (128.71) 178.2  (116.64) 173.6  (94.62) 164.6  (78.71) 173.2  (107.21)
Volume of largest fibroid by US  
Mean (Standard Deviation)
Unit of measure:  Millilitre(s)
Number Analyzed 60 participants 61 participants 61 participants 60 participants 58 participants 300 participants
78.92  (95.644) 77.66  (91.605) 74.55  (88.397) 81.69  (85.62) 99.03  (117.379) 82.22  (95.94)
1.Primary Outcome
Title 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
Time Frame After end of the initial bleeding episode until the end of treatment, up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VPR 4 mg VPR 2 mg VPR 1 mg VPR 0.5 mg Placebo
Hide Arm/Group Description:
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Overall Number of Participants Analyzed 60 61 61 60 58
Measure Type: Number
Unit of Measure: Percentage of subjects
60 54.1 55.7 30 1.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VPR 4 mg, Placebo
Comments The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 58.28
Confidence Interval (2-Sided) 95%
44.55 to 70.94
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VPR 2 mg, Placebo
Comments The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 52.37
Confidence Interval (2-Sided) 95%
38.8 to 65.42
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VPR 1 mg, Placebo
Comments The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 54.01
Confidence Interval (2-Sided) 95%
40.41 to 66.95
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection VPR 0.5 mg, Placebo
Comments The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 28.28
Confidence Interval (2-Sided) 95%
15.92 to 41.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method)
Hide Description In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint for each arm, respectively.
Time Frame From baseline to end of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VPR 4 mg VPR 2 mg VPR 1 mg VPR 0.5 mg Placebo
Hide Arm/Group Description:
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Overall Number of Participants Analyzed 60 61 61 60 58
Mean (Standard Deviation)
Unit of Measure: mL
1st period (N=46, 46, 47, 45, 45) -79.83  (234.22) -30.18  (106.82) -55.42  (109.29) -44.14  (110.61) 17.22  (124.14)
2ndperiod (N=44, 45, 47, 44, 44) -203.43  (215.23) -166.71  (149.57) -181.76  (111.98) -146.32  (136.97) -28.42  (113.93)
3rd period (N=43, 45, 47, 43, 40) -205.08  (214.8) -173.38  (153.37) -185.77  (106.91) -147.55  (138.4) -36.69  (117.98)
3.Secondary Outcome
Title Time to Onset of Controlled Bleeding
Hide Description 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.
Time Frame During treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VPR 4 mg VPR 2 mg VPR 1 mg VPR 0.5 mg Placebo
Hide Arm/Group Description:
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Overall Number of Participants Analyzed 60 61 59 53 26
Median (Inter-Quartile Range)
Unit of Measure: Days
2
(1 to 3)
2
(1 to 3)
3
(1 to 3)
2
(1 to 4)
NA [1] 
(32 to NA)
[1]
insufficient number of participants with events
4.Secondary Outcome
Title Change in Volume of Largest Fibroid Compared to Baseline Measured by MRI
Hide Description 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).
Time Frame From baseline to end of follow-up period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VPR 4 mg VPR 2 mg VPR 1 mg VPR 0.5 mg Placebo
Hide Arm/Group Description:
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Overall Number of Participants Analyzed 60 61 61 60 58
Median (Full Range)
Unit of Measure: mL
End of treatment (N=47, 52, 58, 47, 48)
-41.4
(-98 to 10)
-27.2
(-81 to 47)
-18.9
(-85 to 11314)
-14.9
(-68 to 74)
4.9
(-67 to 271)
Follow-up (N=45, 48, 55, 40, 41)
-26.9
(-94 to 18)
-15
(-82 to 52)
-9.7
(-79 to 437)
-9.3
(-96 to 91)
5.1
(-59 to 364)
5.Other Pre-specified Outcome
Title Exposure-response Analysis of Vilaprisan - Percentage of Subjects Achieving Maximum Effect (Emax) of Induced Amenorrhea
Hide Description 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.
Time Frame From start of the study treatment to Day 84 (treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Full Analysis Set
Hide Arm/Group Description:
FAS (N=300) included all subjects who took at least 1 dose of study drug. Only subjects with valid data for this assessment were included
Overall Number of Participants Analyzed 267
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
59
(49 to 68)
6.Other Pre-specified Outcome
Title Steady-state Exposure Achieving Half-maximal Effect (EAUC50) of Induced Amenorrhea During Treatment Period of Vilaprisan
Hide Description 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.
Time Frame From start of the study treatment to Day 84 (treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Full Analysis Set
Hide Arm/Group Description:
FAS (N=300) included all subjects who took at least 1 dose of study drug. Only subjects with valid data for this assessment were included
Overall Number of Participants Analyzed 267
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: mcg*h/L
36.93
(27.69 to 48.69)
7.Other Pre-specified Outcome
Title Exposure-response Analysis of Vilaprisan - Predicted Percentage of Subjects Below 90% of the Maximum Probability of Induced Amenorrhea
Hide Description 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).
Time Frame From start of the study treatment to Day 84 (treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full Analysis Set
Hide Arm/Group Description:
FAS (N=300) included all subjects who took at least 1 dose of study drug. Only subjects with valid data for this assessment were included.
Overall Number of Participants Analyzed 267
Measure Type: Number
Unit of Measure: Percentage of subjects
1 mg 36
2 mg 2
3 mg 1
8.Other Pre-specified Outcome
Title Assessment of MP to Identify Subjects With Heavy Menstrual Bleeding (HMB)
Hide Description 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.
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Method Interchange Analysis Set
Hide Arm/Group Description:
Method interchange analysis set (N=399) for the assessment of the interchangeability of the menstrual pictogram (MP) and the alkaline hematin (AH) method to judge menstrual blood loss (MBL) included subjects with sanitary product data for which there was a matching pair of MP score and AH value available.
Overall Number of Participants Analyzed 399
Measure Type: Number
Unit of Measure: Percentage
Version 2014: Sensitivity 83.3
Version 2014: Specificity 77.3
Version 2014: PPV 82.1
Version 2014: NPV 78.7
Version 2016: Sensitivity 89.7
Version 2016: Specificity 54.5
Version 2016: PPV 70.6
Version 2016: NPV 81.4
9.Other Pre-specified Outcome
Title Percentage of Subjects With Amenorrhea (Defined as MBL < 2 mL) During the Last 28 Days of Treatment
Hide Description [Not Specified]
Time Frame Last 28 Days of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VPR 4 mg VPR 2 mg VPR 1 mg VPR 0.5 mg Placebo
Hide Arm/Group Description:
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Overall Number of Participants Analyzed 60 61 61 60 58
Measure Type: Number
Unit of Measure: Percentage of subjects
83.33 88.52 85.25 65 8.62
10.Other Pre-specified Outcome
Title Percentage of Subjects With HMB Response During the Last 28 Days of Treatment
Hide Description [Not Specified]
Time Frame Last 28 Days of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VPR 4 mg VPR 2 mg VPR 1 mg VPR 0.5 mg Placebo
Hide Arm/Group Description:
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Overall Number of Participants Analyzed 60 61 61 60 58
Measure Type: Number
Unit of Measure: Percentage of subjects
93.33 96.72 93.44 81.67 29.31
11.Other Pre-specified Outcome
Title Estimated Dose-response Curve Based on Amenorrhea - E0 and Emax
Hide Description The primary objective was to estimate the dose-response curve based on the primary endpoint: subjects with amenorrhea. The number of subjects with amenorrhea was assumed to be binomial distributed. A 4 parameters logistic model was used to fit the observed data for characterizing the dose-response curve: E0, Emax, ED50 and δ. The model is defined as p(d)=E0 + Emax/{1+ e^[{ED50-d)/δ]}. E0 is the amenorrhea rate for placebo; Emax is the maximum effect attributable to the drug (compared with the basal effect with dose at d=0 [placebo group], the maximum increase of drug effect).
Time Frame After end of the initial bleeding episode until the end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full Analysis Set
Hide Arm/Group Description:
FAS (N=300) included all subjects who took at least 1 dose of study drug.
Overall Number of Participants Analyzed 300
Measure Type: Number
Unit of Measure: Percentage
E0 0.82
Emax 57
12.Other Pre-specified Outcome
Title Estimated Dose-response Curve Based on Amenorrhea - ED50
Hide Description The primary objective was to estimate the dose-response curve based on the primary endpoint: subjects with amenorrhea. The number of subjects with amenorrhea was assumed to be binomial distributed. A 4 parameters logistic model was used to fit the observed data for characterizing the dose-response curve: E0, Emax, ED50 and δ. The model is defined as p(d)=E0 + Emax/{1+ e^[{ED50-d)/δ]}. ED50 is the dose at which 50% of Emax were achieved.
Time Frame After end of the initial bleeding episode until the end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full Analysis Set
Hide Arm/Group Description:
FAS (N=300) included all subjects who took at least 1 dose of study drug.
Overall Number of Participants Analyzed 300
Measure Type: Number
Unit of Measure: mg
0.5
13.Other Pre-specified Outcome
Title Estimated Dose-response Curve Based on Amenorrhea - δ
Hide Description The primary objective was to estimate the dose-response curve based on the primary endpoint: subjects with amenorrhea. The number of subjects with amenorrhea was assumed to be binomial distributed. A 4 parameters logistic model was used to fit the observed data for characterizing the dose-response curve: E0, Emax, ED50 and δ. The model is defined as p(d)=E0 + Emax/{1+ e^[{ED50-d)/δ]}. δ is hill slope parameter which measures sensitivity of the response to the dose range of the drug, determining the steepness of the dose-response curve.
Time Frame After end of the initial bleeding episode until the end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full Analysis Set
Hide Arm/Group Description:
FAS (N=300) included all subjects who took at least 1 dose of study drug.
Overall Number of Participants Analyzed 300
Measure Type: Number
Unit of Measure: Slope
0.145
Time Frame From start of study treatment until the end of the 6-month follow-up period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VPR 4 mg VPR 2 mg VPR 1 mg VPR 0.5 mg Placebo
Hide Arm/Group Description Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. Subjects matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
All-Cause Mortality
VPR 4 mg VPR 2 mg VPR 1 mg VPR 0.5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
VPR 4 mg VPR 2 mg VPR 1 mg VPR 0.5 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/60 (3.33%)      4/61 (6.56%)      3/61 (4.92%)      2/60 (3.33%)      2/58 (3.45%)    
Blood and lymphatic system disorders           
Anaemia * 1  0/60 (0.00%)  0 1/61 (1.64%)  1 0/61 (0.00%)  0 1/60 (1.67%)  1 0/58 (0.00%)  0
Gastrointestinal disorders           
Abdominal hernia * 1  0/60 (0.00%)  0 1/61 (1.64%)  1 0/61 (0.00%)  0 0/60 (0.00%)  0 0/58 (0.00%)  0
Hepatobiliary disorders           
Cholelithiasis * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 1/61 (1.64%)  1 0/60 (0.00%)  0 0/58 (0.00%)  0
Infections and infestations           
Pneumonia * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 1/61 (1.64%)  1 0/60 (0.00%)  0 0/58 (0.00%)  0
Investigations           
Alanine aminotransferase increased * 1  1/60 (1.67%)  1 0/61 (0.00%)  0 0/61 (0.00%)  0 0/60 (0.00%)  0 0/58 (0.00%)  0
Aspartate aminotransferase increased * 1  1/60 (1.67%)  1 0/61 (0.00%)  0 0/61 (0.00%)  0 0/60 (0.00%)  0 0/58 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Breast cancer * 1  1/60 (1.67%)  1 0/61 (0.00%)  0 0/61 (0.00%)  0 0/60 (0.00%)  0 0/58 (0.00%)  0
Metastases to ovary * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 1/61 (1.64%)  1 0/60 (0.00%)  0 0/58 (0.00%)  0
Uterine leiomyoma * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/61 (0.00%)  0 1/60 (1.67%)  1 1/58 (1.72%)  1
Pregnancy, puerperium and perinatal conditions           
Abortion spontaneous complete * 1  0/60 (0.00%)  0 1/61 (1.64%)  1 0/61 (0.00%)  0 0/60 (0.00%)  0 0/58 (0.00%)  0
Reproductive system and breast disorders           
Menorrhagia * 1  0/60 (0.00%)  0 1/61 (1.64%)  1 0/61 (0.00%)  0 0/60 (0.00%)  0 0/58 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Pleural effusion * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 1/61 (1.64%)  1 0/60 (0.00%)  0 0/58 (0.00%)  0
Pulmonary embolism * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 0/61 (0.00%)  0 0/60 (0.00%)  0 1/58 (1.72%)  1
Skin and subcutaneous tissue disorders           
Dermatitis contact * 1  0/60 (0.00%)  0 0/61 (0.00%)  0 1/61 (1.64%)  1 0/60 (0.00%)  0 0/58 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
VPR 4 mg VPR 2 mg VPR 1 mg VPR 0.5 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/60 (51.67%)      30/61 (49.18%)      31/61 (50.82%)      32/60 (53.33%)      32/58 (55.17%)    
Blood and lymphatic system disorders           
Anaemia * 1  3/60 (5.00%)  3 3/61 (4.92%)  3 3/61 (4.92%)  4 2/60 (3.33%)  2 5/58 (8.62%)  5
Gastrointestinal disorders           
Abdominal pain * 1  4/60 (6.67%)  9 0/61 (0.00%)  0 1/61 (1.64%)  1 0/60 (0.00%)  0 3/58 (5.17%)  3
Nausea * 1  3/60 (5.00%)  4 3/61 (4.92%)  3 0/61 (0.00%)  0 2/60 (3.33%)  2 0/58 (0.00%)  0
Infections and infestations           
Bacterial vaginosis * 1  0/60 (0.00%)  0 1/61 (1.64%)  1 1/61 (1.64%)  2 3/60 (5.00%)  3 2/58 (3.45%)  2
Nasopharyngitis * 1  3/60 (5.00%)  5 1/61 (1.64%)  1 2/61 (3.28%)  2 4/60 (6.67%)  4 7/58 (12.07%)  7
Urinary tract infection * 1  3/60 (5.00%)  3 0/61 (0.00%)  0 1/61 (1.64%)  1 0/60 (0.00%)  0 3/58 (5.17%)  3
Vulvovaginal mycotic infection * 1  3/60 (5.00%)  3 1/61 (1.64%)  1 4/61 (6.56%)  4 0/60 (0.00%)  0 1/58 (1.72%)  1
Investigations           
Weight increased * 1  4/60 (6.67%)  4 1/61 (1.64%)  1 1/61 (1.64%)  1 0/60 (0.00%)  0 0/58 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Back pain * 1  4/60 (6.67%)  6 4/61 (6.56%)  4 0/61 (0.00%)  0 2/60 (3.33%)  2 2/58 (3.45%)  2
Nervous system disorders           
Dizziness * 1  3/60 (5.00%)  5 0/61 (0.00%)  0 0/61 (0.00%)  0 0/60 (0.00%)  0 1/58 (1.72%)  1
Headache * 1  5/60 (8.33%)  8 5/61 (8.20%)  6 7/61 (11.48%)  13 5/60 (8.33%)  9 7/58 (12.07%)  11
Psychiatric disorders           
Insomnia * 1  3/60 (5.00%)  3 0/61 (0.00%)  0 0/61 (0.00%)  0 0/60 (0.00%)  0 0/58 (0.00%)  0
Reproductive system and breast disorders           
Dysmenorrhoea * 1  2/60 (3.33%)  2 2/61 (3.28%)  2 1/61 (1.64%)  1 4/60 (6.67%)  5 1/58 (1.72%)  1
Menorrhagia * 1  2/60 (3.33%)  3 4/61 (6.56%)  6 6/61 (9.84%)  6 3/60 (5.00%)  4 4/58 (6.90%)  6
Metrorrhagia * 1  5/60 (8.33%)  7 7/61 (11.48%)  17 7/61 (11.48%)  10 4/60 (6.67%)  5 1/58 (1.72%)  1
Ovarian cyst * 1  4/60 (6.67%)  5 5/61 (8.20%)  5 4/61 (6.56%)  6 15/60 (25.00%)  16 5/58 (8.62%)  7
Skin and subcutaneous tissue disorders           
Acne * 1  3/60 (5.00%)  3 1/61 (1.64%)  1 2/61 (3.28%)  4 1/60 (1.67%)  1 0/58 (0.00%)  0
Vascular disorders           
Hot flush * 1  8/60 (13.33%)  8 5/61 (8.20%)  5 5/61 (8.20%)  6 6/60 (10.00%)  8 4/58 (6.90%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: BAYER
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02131662     History of Changes
Other Study ID Numbers: 15788
2013-003945-40 ( EudraCT Number )
First Submitted: May 5, 2014
First Posted: May 6, 2014
Results First Submitted: May 3, 2017
Results First Posted: December 8, 2017
Last Update Posted: December 8, 2017