To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)
Condition: Contraception
Intervention: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027); Ortho Tri Cyclen Lo
Intervention description: Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated BAY86-5027 for 28 days per Cycle, for 13 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo; Dose--Ethinylestradiol (EE) + Norgestimate (NGM) Triphasic 21-day regimen. Daily oral administration of one encapsulated Ortho Tri-Cyclen Lo for 28 days per Cycle, for 13 treatment cycles: Days 1-7, 0.025 mg EE+0.180 NGM; Days 8-14, 0.025 mg EE+0.215 NGM; Days 15-21, 0.025 mg EE+0.250 NGM; Days 27-28, placebo
Intervention MeSH terms: Moxifloxacin; Dienogest; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norgestimate, ethinyl estradiol drug combination; Estradiol; Polyestradiol phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 409.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Oral contraceptive; Estradiol valerate and dienogest; EV/DNG; comparative tolerability

Summary:

      The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho
      Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50 years
      of age who request oral contraceptive protection. Subjects on a levonorgestrel (LNG),
      norgestimate (NGM), norethindrone or norethindrone acetate containing oral contraceptive in a
      21-day regimen suffering from hormone withdrawal-associated symptoms such as pelvic pain or
      headache or both, and willing to continue OC use but to switch to SH T00658ID or Ortho
      Tri-Cyclen Lo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent

          -  Age between 18 and 50 years (inclusive), smokers maximum age of 35 years (inclusive)
             at Visit 1

          -  Otherwise healthy female subjects requesting contraception and currently using a LNG,
             NGM, or norethindrone/norethindrone acetate containing OC in a 21-day regimen and
             suffering from at least moderate pelvic pain, headache or both defined by an average
             of the highest 3 values of >/=35 mm on a VAS during cycle days 22-28 (35 mm VAS is the
             expected standard deviation of the population VAS reduction)

          -  Normal or clinically insignificant cervical smear not requiring further follow up (a
             cervical smear has to be taken at screening visit or a normal result has to be
             documented within the last 6 months before screening) Women with atypical squamous
             cell of undetermined significance (ASCUS) can be included if they have a negative
             human papilloma virus (HPV) test result. The laboratory will perform an HPV test if
             the Pap smear result is ASCUS.

          -  Able to tolerate ibuprofen and willing to use only ibuprofen supplied by the
             investigator

        Exclusion Criteria:

          -  Pregnancy or lactation (less than three cycles since delivery, abortion, or lactation
             before start of treatment)

          -  Body mass index (BMI) >32 kg/m2

          -  Hypersensitivity to any of the study drug ingredients

          -  Individuals not willing to consume pork and beef products. Women may be included if
             they are willing to take the capsules

          -  Safety relevant laboratory values, provided by the central laboratory, outside
             inclusion range before start of treatment

          -  Any diseases or conditions that can compromise the function of the body systems and
             could result in altered absorption, excessive accumulation, impaired metabolism, or
             altered excretion of the study medication (such as but not limited to duodenal ulcers,
             gastritis, gastrectomy or gastric resection surgery, or renal compromise)

          -  Any diseases or conditions that might interfere with the conduct of the study or the
             interpretation of the results

          -  Any disease or condition that may worsen under hormonal treatment

          -  Undiagnosed abnormal genital bleeding

          -  Abuse of alcohol, drugs, or medicines (eg, laxatives)

          -  Other contraceptive methods

          -  Any medication that could result in excessive accumulation, impaired metabolism, or
             altered excretion of the study drug or interfere with the conduct of the study or the
             interpretation of the results

          -  Simultaneous 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

          -  Subject is a dependent person, eg: a family member or member of the Investigator's
             staff

          -  Inability to cooperate with the study procedures for any reason, including language
             comprehension, psychiatric illness, inability to get to the study site