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SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00511797
First received: August 3, 2007
Last updated: December 26, 2012
Last verified: December 2012
History of Changes
Results First Received: April 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Dysmenorrhea
Interventions: Drug: SH T04740B
Drug: SH T00186DF
Drug: SH T04740F
Drug: Placebo

  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 who received at least one dose of study drug. Patients were analyzed as treated.

FAS was the primary analysis set for all efficacy endpoints and safety analyses. Per Protocol Set (PPS) was a subgroup of the FAS. The PPS consisted of patients in the FAS who did not have major protocol deviations.

Reporting Groups
  Description
DRSP 1 mg/EE 20 μg 1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
DRSP 2 mg/EE 20 μg 1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
DRSP 3 mg/EE 20 μg 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
Placebo 1 tablet per day placebo for 28 days in each 28-day cycle

Participant Flow:   Overall Study
    DRSP 1 mg/EE 20 μg     DRSP 2 mg/EE 20 μg     DRSP 3 mg/EE 20 μg     Placebo  
STARTED     62     63     62     62  
Subjects Dispensed Drugs     61     63     61     59  
Subjects Received Treatment     61 [1]   62 [1]   61 [1]   58 [1]
COMPLETED     55     55     51     47  
NOT COMPLETED     7     8     11     15  
Adverse Event                 1                 2                 2                 2  
Lost to Follow-up                 1                 0                 0                 1  
Pregnancy                 0                 0                 0                 1  
Protocol Violation                 0                 2                 2                 3  
Withdrawal by Subject                 3                 3                 4                 2  
Never dispensed                 1                 0                 1                 3  
Study drug not taken                 0                 1                 0                 1  
Partially missing diary                 0                 0                 1                 0  
Other (moving etc)                 1                 0                 1                 2  
[1] FAS



  Baseline Characteristics
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Reporting Groups
  Description
DRSP 1 mg/EE 20 μg 1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
DRSP 2 mg/EE 20 μg 1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
DRSP 3 mg/EE 20 μg 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
Placebo 1 tablet per day placebo for 28 days in each 28-day cycle
Total Total of all reporting groups

Baseline Measures
    DRSP 1 mg/EE 20 μg     DRSP 2 mg/EE 20 μg     DRSP 3 mg/EE 20 μg     Placebo     Total  
Number of Participants  
[units: participants]
 		  61     62     61     58     242  
Age  
[units: years]
Mean ( Full Range ) 		  31.0  
  ( 21 to 45 )   		  30.6  
  ( 20 to 43 )   		  30.9  
  ( 20 to 48 )   		  30.8  
  ( 20 to 44 )   		  30.8  
  ( 20 to 48 )  
Gender  
[units: participants]
 		         
Female     61     62     61     58     242  
Male     0     0     0     0     0  
Diagnosis type  
[units: participants]
 		         
Functional dysmenorrhea     47     48     42     41     178  
Organic dysmenorrhea     14     14     19     17     64  
Details of organic dysmenorrhea [1]
[units: participants]
 		         
Endometriosis     1     3     4     5     13  
Uterine fibroids     9     7     10     9     35  
Uterine adenomyosis     6     7     11     8     32  
Bicornuate uterus     2     0     0     0     2  
Average length of menstrual cycle  
[units: days]
Mean ( Full Range ) 		  28.6  
  ( 25 to 31 )   		  28.7  
  ( 25 to 33 )   		  28.3  
  ( 25 to 32 )   		  28.7  
  ( 25 to 31 )   		  28.6  
  ( 25 to 33 )  
Body mass index (BMI)  
[units: kg/m^2]
Mean ( Full Range ) 		  21.05  
  ( 15.6 to 30.0 )   		  20.41  
  ( 16.6 to 25.8 )   		  20.67  
  ( 16.4 to 29.9 )   		  21.19  
  ( 17.2 to 27.7 )   		  20.82  
  ( 15.6 to 30.0 )  
[1] Not all participants had organic dysmenorrhea. Some of participants were diagnosed as having a multiple type of organic dysmenorrhea.



  Outcome Measures
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1.  Primary:   Change From Baseline in Total Dysmenorrheal Score at Final Evaluation   [ Time Frame: Baseline and up to 4 Cycles (28 days per cycle) ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4   [ Time Frame: Baseline and up to 4 Cycles (28 days per cycle) ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4   [ Time Frame: Cycle 4 (28 days per cycle) ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4   [ Time Frame: Cycle 4 (28 days per cycle) ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With Severity of Headache During Menstruation at Cycle 4   [ Time Frame: Cycle 4 (28 days per cycle) ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4   [ Time Frame: Cycle 4 (28 days per cycle) ]
  Show Outcome Measure 6

7.  Secondary:   Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4   [ Time Frame: Cycle 4 (28 days per cycle) ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4   [ Time Frame: From baseline up to Cycle 4 (28 days per cycle) ]
  Show Outcome Measure 8

9.  Secondary:   Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4   [ Time Frame: Cycle 4 (28 days per cycle) ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline in Endometrial Thickness After 4-cycle Treatment   [ Time Frame: From baseline to Cycle 4 (28 days per cycle) ]
  Show Outcome Measure 10

11.  Secondary:   Number of Bleeding / Spotting Episodes   [ Time Frame: For the first 90 days ]
  Show Outcome Measure 11

12.  Secondary:   Number of Bleeding / Spotting Days   [ Time Frame: For the first 90 days ]
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13.  Secondary:   Participants With Withdrawal Bleeding   [ Time Frame: At Cycle 4 (28 days per cycle) ]
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14.  Secondary:   Participants With Intracyclic Bleeding   [ Time Frame: At Cycle 4 (28 days per cycle) ]
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15.  Secondary:   Participants With Non-heavy Intracyclic Bleeding   [ Time Frame: At Cycle 4 (28 days per cycle) ]
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16.  Secondary:   Participants With Non-heavy Withdrawal Bleeding   [ Time Frame: At Cycle 4 (28 dyas per cycle) ]
  Show Outcome Measure 16

17.  Secondary:   Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment   [ Time Frame: From baseline to Cycle 4 (28 days per cycle) ]
  Show Outcome Measure 17

18.  Secondary:   Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment   [ Time Frame: From baseline to Cycle 4 (28 days per cycle) ]
  Show Outcome Measure 18

19.  Secondary:   Change From Baseline in Serum Estradiol Level After 4-cycle Treatment   [ Time Frame: From baseline to Cycle 4 (28 days per cycle) ]
  Show Outcome Measure 19

20.  Secondary:   Change From Baseline in Serum Progesterone Level at Cycle 4   [ Time Frame: From baseline to Cycle 4 (28 days per cycle) ]
  Show Outcome Measure 20

21.  Post-Hoc:   Change From Baseline for Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4   [ Time Frame: From baseline to Cycle 4(28 days per cycle) ]
  Show Outcome Measure 21

22.  Post-Hoc:   Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (1)   [ Time Frame: Baseline and up to Cycle 4 (28 days per cycle) ]
  Show Outcome Measure 22

23.  Post-Hoc:   Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (2)   [ Time Frame: Baseline and up to 4 Cycles (28 days per cycle) ]
  Show Outcome Measure 23

24.  Post-Hoc:   Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Patients Without Previous Medication   [ Time Frame: Baseline and up to 4 Cycles (28 days per cycle) ]
  Show Outcome Measure 24


  Serious Adverse Events
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  Other Adverse Events
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  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.


Limitations and Caveats
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.  


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: NCT00511797     History of Changes
Other Study ID Numbers: 91615, 310283
Study First Received: August 3, 2007
Results First Received: April 15, 2010
Last Updated: December 26, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare