Phase 3
N=507
Effect on Primary Dysmenorrhea
Primary Dysmenorrhea
Bottom Line
View on ClinicalTrials.gov: NCT00909857 ↗Enrolled (actual)
507
Serious AEs
0.9%
Results posted
Feb 2012
Primary outcome: Primary: Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain — -4.6; -4.2 Days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) (Drug); Ethinyl estradiol, Levonorgestrel (Miranova) (Drug); Placebo Match to SH T00658ID (Drug); Placebo Match to SH D593B (Drug)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- Female
- Sponsor
- Bayer
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain |
-4.6; -4.2 | — |
| SECONDARY Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain |
-10.6; -10.0 | — |
| SECONDARY Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding |
-4.0; -3.7 | — |
| SECONDARY Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding |
0.3; 0.1 | — |
| 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) |
-6.2; -6.6 | — |
| SECONDARY Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used) |
-4.5; -5.6 | — |
| 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) |
92.3; 91.3; 90.6; 89.6; 51.7; 56.5 | — |
| SECONDARY Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used) |
93.2; 92.2; 92.3; 90.0; 54.7; 60.0 | — |
| SECONDARY Percentage of Participants Satisfied With Study Treatment |
0.9; 1.3; 53.4; 50.4; 32.1; 30.0 | — |
| SECONDARY Number of Days With Bleeding or Spotting |
20.0; 23.6 | — |
| SECONDARY Number of Episodes With Bleeding or Spotting |
3.9; 4.1 | — |
| SECONDARY Mean Length of Bleeding or Spotting Episodes |
5.17; 5.83 | — |
| SECONDARY Maximum Length of Bleeding or Spotting Episodes |
7.1; 8.4 | — |
| SECONDARY Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode |
3.6; 4.6 | — |
| SECONDARY Number of Days With Spotting-only |
7.3; 7.6 | — |
| SECONDARY Number of Episodes With Spotting-only |
0.5; 0.4 | — |
| SECONDARY Mean Length of Spotting Only Episodes |
3.29; 3.26 | — |
| SECONDARY Maximum Length of Spotting Only Episodes |
3.9; 3.6 | — |
| SECONDARY Difference in Duration Between Longest and Shortest Spotting Only Episode |
1.2; 0.7 | — |
| SECONDARY Percentage of Participants With Withdrawal Bleeding at Cycle 1 |
91.2; 93.2 | — |
| SECONDARY Percentage of Participants With Withdrawal Bleeding at Cycle 3 |
68.1; 79.3 | — |
| SECONDARY Length of Withdrawal Bleeding Episodes at Cycle 1 |
5.2; 5.4 | — |
| SECONDARY Length of Withdrawal Bleeding Episodes at Cycle 3 |
4.5; 5.2 | — |
| SECONDARY Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 |
3.7; 4.0 | — |
| SECONDARY Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 |
3.7; 4.1 | — |
| SECONDARY Onset of Withdrawal Bleeding Episodes at Cycle 1 |
4.8; 4.9 | — |
| SECONDARY Onset of Withdrawal Bleeding Episodes at Cycle 3 |
3.1; 4.3 | — |
| SECONDARY Percentage of Participants With Intracyclic Bleeding at Cycle 1 |
19.0; 16.7 | — |
| SECONDARY Percentage of Participants With Intracyclic Bleeding at Cycle 3 |
10.8; 11.6 | — |
| SECONDARY Number of Intracyclic Bleeding Episodes at Cycle 1 |
0.2; 0.2 | — |
| SECONDARY Number of Intracyclic Bleeding Episodes at Cycle 3 |
0.1; 0.1 | — |
| SECONDARY Maximum Length of Intracyclic Bleeding Episodes at Cycle 1 |
6.0; 6.2 | — |
| SECONDARY Maximum Length of Intracyclic Bleeding Episodes at Cycle 3 |
5.5; 4.9 | — |
| SECONDARY Number of Intracyclic Bleeding Days at Cycle 1 |
1.2; 1.0 | — |
| SECONDARY Number of Intracyclic Bleeding Days at Cycle 3 |
0.6; 0.6 | — |
| SECONDARY Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 |
53.5; 62.2; 30.2; 10.8; 9.3; 13.5 | — |
| SECONDARY Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 |
45.5; 30.4; 27.3; 21.7; 13.6; 30.4 | — |
| SECONDARY Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening |
0.4; 0.0; 38.0; 40.4; 16.2; 16.1 | — |
| SECONDARY Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle |
0.0; 0.0; 47.9; 51.7; 13.2; 11.7 | — |
| SECONDARY Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2 |
0.0; 0.0; 78.6; 72.6; 8.5; 6.5 | — |
| SECONDARY Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination |
0.4; 0.0; 85.9; 85.2; 5.6; 2.6 | — |
| SECONDARY Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire |
0.00; 0.00 | — |
| SECONDARY Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire |
5.46; 5.04 | — |
| SECONDARY Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire |
0.00; 0.00 | — |
| SECONDARY Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire |
0.00; 0.00 | — |
| SECONDARY Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire |
0.00; 0.00 | — |
| SECONDARY Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire |
0.00; 0.00 | — |
| SECONDARY Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire |
0.00; 0.00 | — |
| SECONDARY Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire |
0.00; 0.00 | — |
| SECONDARY Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire |
0.00; 0.00 | — |
| SECONDARY Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression |
0; 0; 1; 1; 63; 42 | — |
| SECONDARY Participants With Improvement in Participants' Assessment in the Clinical Global Impression |
1; 0; 1; 1; 60; 46 | — |
| SECONDARY Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle |
90.2; 89.6 | — |
| SECONDARY Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination |
93.7; 92.5 | — |
| SECONDARY Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle |
78.85; 77.35 | — |
| SECONDARY Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination |
85.95; 84.79 | — |
| SECONDARY Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle |
73.6; 72.6 | — |
| SECONDARY Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination |
77.3; 76.4 | — |
| SECONDARY Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle |
62.6; 62.2 | — |
| SECONDARY Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination |
68.2; 67.2 | — |
| SECONDARY General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle |
75.8; 72.7 | — |
| SECONDARY General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination |
77.2; 76.5 | — |
| SECONDARY Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle |
77.8; 79.4 | — |
| SECONDARY Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination |
89.6; 87.9 | — |
| SECONDARY Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle |
81.91; 79.18 | — |
| SECONDARY Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination |
88.64; 83.87 | — |
| SECONDARY Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle |
50.7; 51.8 | — |
| SECONDARY Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination |
77.0; 74.0 | — |
Summary
To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.
Eligibility Criteria
Inclusion Criteria
- Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of >/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score
- Age: 14 - 50 years (inclusive; smokers must not be older than 30 years) at the time point of informed consent
- Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at the screening visit, or a normal result has to be available that was documented within the last 6 months before the screening visit)
- Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to visit 1.
- Able to tolerate ibuprofen and willing to use only Ibuprofen supplied for the study.
Exclusion Criteria
- Pregnancy or lactation (delivery, abortion, or lactation within three cycles before the start of treatment)
- Obesity: body mass index (BMI) > 32 kg/m2
- Hypersensitivity to any of the study drug ingredients
- Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- Presence or a history of venous or arterial thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris), and conditions that could increase the risk of suffering from any of the above mentioned disorders, e.g. a family history indicating a hereditary predispositionUndiagnosed abnormal genital bleeding
- Abuse of alcohol, drugs, or medicines (e.g. laxatives)
- Other contraceptive methods:
- Sterilization
- Oral, vaginal or transdermal hormonal contraception during treatment
- Intra-uterine devices (IUD) with or without hormone release still in place within 30 days of visit 1
- Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator
- Major surgery scheduled for the study period
Data sourced from ClinicalTrials.gov (NCT00909857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.