Effect on Primary Dysmenorrhea

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.

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