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A Multi-center, Double-blind, Double-dummy, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of SH T00658ID Compared to SH D593B in the Treatment of Primary Dysmenorrhea
To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.
Details
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 507 |
| Start date | 2009-04 |
| Completion | 2010-11 |
Conditions
- Primary Dysmenorrhea
Interventions
- Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
- Ethinyl estradiol, Levonorgestrel (Miranova)
- Placebo Match to SH T00658ID
- Placebo Match to SH D593B
Primary outcomes
- Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain — baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Countries
United States, Canada, Chile, Germany, Italy, Philippines