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Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00461305
First received: April 17, 2007
Last updated: January 22, 2013
Last verified: January 2013
Results First Received: September 10, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Dysmenorrhea
Interventions: Drug: DRSP 3 mg/EE 20 µg (13 cycles)
Drug: DRSP 3 mg/EE 30 µg (6 cycles)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Full Analysis Set (FAS) consisted of all patients randomized who received at least one dose of study drug. Patients were analyzed as treated. FAS was the primary analysis set for the efficacy and safety. Per Protocol Set (PPS) was a subgroup of the FAS. The PPS consisted of patients in the FAS without major protocol deviations reported by Cycle 6.

Reporting Groups
  Description
DRSP 3 mg/EE 20 µg (13 Cycles) 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
DRSP 3 mg/EE 30 µg (6 Cycles) 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)

Participant Flow for 2 periods

Period 1:   Treatment
    DRSP 3 mg/EE 20 µg (13 Cycles)     DRSP 3 mg/EE 30 µg (6 Cycles)  
STARTED     355 [1]   65 [1]
Subjects Dispensed Drugs     350     65  
Subjects Received Treatment     349 [2]   65 [2]
COMPLETED     254     56  
NOT COMPLETED     101     9  
Adverse Event                 26                 3  
Lost to Follow-up                 4                 2  
Protocol Violation                 13                 2  
Withdrawal by Subject                 48                 2  
Never dispensed                 5                 0  
Study drug not taken                 1                 0  
Partially missing diary                 2                 0  
Other (missing drug etc)                 2                 0  
[1] Enrolled
[2] FAS, safety population

Period 2:   Continued Treatment
    DRSP 3 mg/EE 20 µg (13 Cycles)     DRSP 3 mg/EE 30 µg (6 Cycles)  
STARTED     349 [1]   0 [2]
COMPLETED     254     0  
NOT COMPLETED     95     0  
Adverse Event                 26                 0  
Lost to Follow-up                 4                 0  
Protocol Violation                 13                 0  
Withdrawal by Subject                 48                 0  
Partially missing diary                 2                 0  
Other (missing drug etc)                 2                 0  
[1] FAS, participants from previous treatment who were available to continue treatment
[2] no participants were treated with the DRSP 3 mg/EE 30 μg combination beyond 6 cycles



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
DRSP 3 mg/EE 20 µg (13 Cycles) 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
DRSP 3 mg/EE 30 µg (6 Cycles) 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Total Total of all reporting groups

Baseline Measures
    DRSP 3 mg/EE 20 µg (13 Cycles)     DRSP 3 mg/EE 30 µg (6 Cycles)     Total  
Number of Participants  
[units: participants]
  349     65     414  
Age  
[units: years]
Mean ( Full Range )
  29.0  
  ( 20 to 44 )  
  30.9  
  ( 20 to 43 )  
  29.3  
  ( 20 to 44 )  
Gender  
[units: participants]
     
Female     349     65     414  
Male     0     0     0  
Diagnosis type  
[units: participants]
     
Functional dysmenorrhea     273     53     326  
Organic dysmenorrhea     76     12     88  
Details of organic dysmenorrhea [1]
[units: participants]
     
Endometriosis     24     4     28  
Uterine fibroids     27     7     34  
Uterine adenomyosis     35     8     43  
Endometrial polyp     1     0     1  
Bicornuate uterus     3     0     3  
Multiple endometrial polyp     1     0     1  
Uterine enlargement     1     0     1  
Average length of menstrual cycle  
[units: days]
Mean ( Full Range )
  29.5  
  ( 25 to 38 )  
  29.5  
  ( 25 to 38 )  
  29.5  
  ( 25 to 38 )  
Body Mass Index  
[units: kg/m^2]
Mean ( Full Range )
  20.73  
  ( 16.2 to 29.9 )  
  20.56  
  ( 15.3 to 28.7 )  
  20.70  
  ( 15.3 to 29.9 )  
[1] Not all participants had organic dysmenorrhea. Some of participants were diagnosed as having a multiple type of organic dysmenorrhea.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Intracyclic Bleeding at Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

2.  Secondary:   Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6   [ Time Frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle ]

3.  Secondary:   Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13   [ Time Frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle ]

4.  Secondary:   Distribution of Total Dysmenorrhea Score at Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

5.  Secondary:   Distribution of Total Dysmenorrhea Score at Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

6.  Secondary:   Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

7.  Secondary:   Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

8.  Secondary:   Distribution of Severity of Lumbago During Menstruation at Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

9.  Secondary:   Distribution of Severity of Lumbago During Menstruation at Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

10.  Secondary:   Distribution of Severity of Headache During Menstruation at Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

11.  Secondary:   Distribution of Severity of Headache During Menstruation at Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

12.  Secondary:   Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

13.  Secondary:   Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

14.  Secondary:   Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

15.  Secondary:   Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

16.  Secondary:   Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6   [ Time Frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle ]

17.  Secondary:   Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13   [ Time Frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle ]

18.  Secondary:   Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6   [ Time Frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle ]

19.  Secondary:   Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13   [ Time Frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle ]

20.  Secondary:   Number of Any Bleeding Episodes From Cycle 1 to Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

21.  Secondary:   Number of Any Bleeding Episodes From Cycle 1 to Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

22.  Secondary:   Number of Any Bleeding Days From Cycle 1 to Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

23.  Secondary:   Number of Any Bleeding Days From Cycle 1 to Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

24.  Secondary:   Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

25.  Secondary:   Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

26.  Secondary:   Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

27.  Secondary:   Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

28.  Secondary:   Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

29.  Secondary:   Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

30.  Secondary:   Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6   [ Time Frame: Up to Cycle 6 (168 days) with 28 days per cycle ]

31.  Secondary:   Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13   [ Time Frame: Up to Cycle 13 (364 days) with 28 days per cycle ]

32.  Secondary:   Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6   [ Time Frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle ]

33.  Secondary:   Change in Serum CA-125 From Baseline to Cycle 13   [ Time Frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle ]

34.  Secondary:   Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6   [ Time Frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle ]

35.  Secondary:   Change in Serum CRP From Baseline to Cycle 13   [ Time Frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle ]

36.  Post-Hoc:   Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6   [ Time Frame: Baseline and up to Cycle 6 (168 days) with 28 days per cycle ]

37.  Post-Hoc:   Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13   [ Time Frame: Baseline and up to Cycle 13 (364 days) with 28 days per cycle ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided


Responsible Party: Therapeutic Area Head, Bayer Yakuhin, Ltd.
ClinicalTrials.gov Identifier: NCT00461305     History of Changes
Other Study ID Numbers: 91616, 310284
Study First Received: April 17, 2007
Results First Received: September 10, 2010
Last Updated: January 22, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare