Effect on Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Intervention: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027); Ethinyl estradiol, Levonorgestrel (Miranova); Placebo Match to SH T00658ID; Placebo Match to SH D593B
Intervention description: Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval; Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval; Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.; Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
Intervention MeSH terms: Dienogest; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Levonorgestrel; Ethinyl Estradiol; Estradiol; Polyestradiol phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 507.0
Sex: Female
Minimum age: 14 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Primary Dysmenorrhea; Oral Contraception

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