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Effect on Primary Dysmenorrhea

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ClinicalTrials.gov Identifier: NCT00909857
Recruitment Status : Completed
First Posted : May 29, 2009
Results First Posted : February 27, 2012
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Primary Dysmenorrhea
Interventions: Drug: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Drug: Ethinyl estradiol, Levonorgestrel (Miranova)
Drug: Placebo Match to SH T00658ID
Drug: Placebo Match to SH D593B

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants aged 14 to 50 years with a need for oral contraception suffering from primary dysmenorrhea were recruited at specialized study sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 771 participants screened, 264 failed screening, mostly due to not meeting in-/exclusion criteria (155), withdrawal of consent (49), loss to follow-up (36) or pregnancy (10). Thus, 507 participants were randomized (253 to Estradiol valerate/Dienogest and 254 to Ethinyl estradiol/Levonorgestrel).

Reporting Groups
  Description
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Ethinyl Estradiol, Levonorgestrel (Miranova) Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles

Participant Flow:   Overall Study
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)   Ethinyl Estradiol, Levonorgestrel (Miranova)
STARTED   253   254 
Treated   234   230 
COMPLETED   217   209 
NOT COMPLETED   36   45 
Withdrawal by Subject                6                10 
Adverse Event                5                5 
Lost to Follow-up                2                5 
Protocol Violation                2                1 
Pregnancy                1                0 
Other                1                0 
Did not receive study medication                19                24 



  Baseline Characteristics

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
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Ethinyl Estradiol, Levonorgestrel (Miranova) Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Total Total of all reporting groups

Baseline Measures
   Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)   Ethinyl Estradiol, Levonorgestrel (Miranova)   Total 
Overall Participants Analyzed 
[Units: Participants]
 234   230   464 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.0  (7.9)   27.6  (8.0)   27.8  (7.9) 
Age, Customized 
[Units: Participants]
     
less than 18 years of age   11   13   24 
18 years of age or older   223   217   440 
Gender 
[Units: Participants]
     
Female   234   230   464 
Male   0   0   0 


  Outcome Measures

1.  Primary:   Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain   [ Time Frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) ]

2.  Secondary:   Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain   [ Time Frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) ]

3.  Secondary:   Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding   [ Time Frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) ]

4.  Secondary:   Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding   [ Time Frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) ]

5.  Secondary:   Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)   [ Time Frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) ]

6.  Secondary:   Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)   [ Time Frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) ]

7.  Secondary:   Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)   [ Time Frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) ]

8.  Secondary:   Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)   [ Time Frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) ]

9.  Secondary:   Percentage of Participants Satisfied With Study Treatment   [ Time Frame: From cycle 1 to cycle 3 (28 days per cycle) ]

10.  Secondary:   Number of Days With Bleeding or Spotting   [ Time Frame: From day 1 to day 90 ]

11.  Secondary:   Number of Episodes With Bleeding or Spotting   [ Time Frame: From day 1 to day 90 ]

12.  Secondary:   Mean Length of Bleeding or Spotting Episodes   [ Time Frame: From day 1 to day 90 ]

13.  Secondary:   Maximum Length of Bleeding or Spotting Episodes   [ Time Frame: From day 1 to day 90 ]

14.  Secondary:   Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode   [ Time Frame: From day 1 to day 90 ]

15.  Secondary:   Number of Days With Spotting-only   [ Time Frame: From day 1 to day 90 ]

16.  Secondary:   Number of Episodes With Spotting-only   [ Time Frame: From day 1 to day 90 ]

17.  Secondary:   Mean Length of Spotting Only Episodes   [ Time Frame: From day 1 to day 90 ]

18.  Secondary:   Maximum Length of Spotting Only Episodes   [ Time Frame: From day 1 to day 90 ]

19.  Secondary:   Difference in Duration Between Longest and Shortest Spotting Only Episode   [ Time Frame: From day 1 to day 90 ]

20.  Secondary:   Percentage of Participants With Withdrawal Bleeding at Cycle 1   [ Time Frame: At cycle 1 (28 days per cycle) ]

21.  Secondary:   Percentage of Participants With Withdrawal Bleeding at Cycle 3   [ Time Frame: At cycle 3 (28 days per cycle) ]

22.  Secondary:   Length of Withdrawal Bleeding Episodes at Cycle 1   [ Time Frame: At cycle 1 (28 days per cycle) ]

23.  Secondary:   Length of Withdrawal Bleeding Episodes at Cycle 3   [ Time Frame: At cycle 3 (28 days per cycle) ]

24.  Secondary:   Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1   [ Time Frame: At cycle 1 (28 days per cycle) ]

25.  Secondary:   Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3   [ Time Frame: At cycle 3 (28 days per cycle) ]

26.  Secondary:   Onset of Withdrawal Bleeding Episodes at Cycle 1   [ Time Frame: At cycle 1 (28 days per cycle) ]

27.  Secondary:   Onset of Withdrawal Bleeding Episodes at Cycle 3   [ Time Frame: At cycle 3 (28 days per cycle) ]

28.  Secondary:   Percentage of Participants With Intracyclic Bleeding at Cycle 1   [ Time Frame: At cycle 1 (28 days per cycle) ]

29.  Secondary:   Percentage of Participants With Intracyclic Bleeding at Cycle 3   [ Time Frame: At cycle 3 (28 days per cycle) ]

30.  Secondary:   Number of Intracyclic Bleeding Episodes at Cycle 1   [ Time Frame: At cycle 1 (28 days per cycle) ]

31.  Secondary:   Number of Intracyclic Bleeding Episodes at Cycle 3   [ Time Frame: At cycle 3 (28 days per cycle) ]

32.  Secondary:   Maximum Length of Intracyclic Bleeding Episodes at Cycle 1   [ Time Frame: At cycle 1 (28 days per cycle) ]

33.  Secondary:   Maximum Length of Intracyclic Bleeding Episodes at Cycle 3   [ Time Frame: At cycle 3 (28 days per cycle) ]

34.  Secondary:   Number of Intracyclic Bleeding Days at Cycle 1   [ Time Frame: At cycle 1 (28 days per cycle) ]

35.  Secondary:   Number of Intracyclic Bleeding Days at Cycle 3   [ Time Frame: At cycle 3 (28 days per cycle) ]

36.  Secondary:   Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1   [ Time Frame: At cycle 1 (28 days per cycle) ]

37.  Secondary:   Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3   [ Time Frame: At cycle 3 (28 days per cycle) ]

38.  Secondary:   Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening   [ Time Frame: At screening (28 days) ]

39.  Secondary:   Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle   [ Time Frame: At Baseline (28 days per cycle) ]

40.  Secondary:   Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2   [ Time Frame: At cycle 2 (28 days per cycle) ]

41.  Secondary:   Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination   [ Time Frame: At final examination (28 days) ]

42.  Secondary:   Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire   [ Time Frame: At screening (average over 3 months before screening) ]

43.  Secondary:   Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire   [ Time Frame: At screening (average over 3 months before screening) ]

44.  Secondary:   Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire   [ Time Frame: At screening (average over 3 months before screening) ]

45.  Secondary:   Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire   [ Time Frame: At screening (average over 3 months before screening) ]

46.  Secondary:   Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire   [ Time Frame: At screening (average over 3 months before screening) ]

47.  Secondary:   Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire   [ Time Frame: At screening (average over 3 months before screening) ]

48.  Secondary:   Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire   [ Time Frame: At screening (average over 3 months before screening) ]

49.  Secondary:   Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire   [ Time Frame: At screening (average over 3 months before screening) ]

50.  Secondary:   Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire   [ Time Frame: At screening (average over 3 months before screening) ]

51.  Secondary:   Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression   [ Time Frame: At cycle 2 (28 days per cycle) ]

52.  Secondary:   Participants With Improvement in Participants' Assessment in the Clinical Global Impression   [ Time Frame: At cycle 2 (28 days per cycle) ]

53.  Secondary:   Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle   [ Time Frame: At baseline cycle (28 days per cycle) ]

54.  Secondary:   Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination   [ Time Frame: at final examination (28 days) ]

55.  Secondary:   Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle   [ Time Frame: At baseline cycle (28 days per cycle) ]

56.  Secondary:   Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination   [ Time Frame: At final examination (28 days) ]

57.  Secondary:   Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle   [ Time Frame: At baseline cycle (28 days per cycle) ]

58.  Secondary:   Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination   [ Time Frame: At final examination (28 days) ]

59.  Secondary:   Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle   [ Time Frame: At baseline cycle (28 days per cycle) ]

60.  Secondary:   Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination   [ Time Frame: At final examination (28 days) ]

61.  Secondary:   General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle   [ Time Frame: At baseline cycle (28 days per cycle) ]

62.  Secondary:   General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination   [ Time Frame: At final examination (28 days) ]

63.  Secondary:   Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle   [ Time Frame: At baseline cycle (28 days per cycle) ]

64.  Secondary:   Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination   [ Time Frame: At final examination (28 days) ]

65.  Secondary:   Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle   [ Time Frame: At baseline cycle (28 days per cycle) ]

66.  Secondary:   Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination   [ Time Frame: At final examination (28 days) ]

67.  Secondary:   Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle   [ Time Frame: At baseline cycle (28 days per cycle) ]

68.  Secondary:   Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination   [ Time Frame: At final examination (28 days) ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00909857     History of Changes
Other Study ID Numbers: 91781
2008-005625-11 ( EudraCT Number )
312042 ( Other Identifier: Bayer )
First Submitted: April 24, 2009
First Posted: May 29, 2009
Results First Submitted: November 15, 2011
Results First Posted: February 27, 2012
Last Update Posted: August 24, 2015