SH T00186 in the Treatment of Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigational drug SH T00186D is an oral contraceptive. The investigational drug used
      in this study contains the estrogen ethinylestradiol (EE) and the progestogen drospirenone
      (DRSP).

      The aim of the present study is to evaluate efficacy and safety of the investigational drug
      in the treatment of menstrual pain (pelvic pain occurring shortly before, at onset, during
      menstruation). Two different regimens of intake of the same investigational product will be
      compared.

      Patients have to undergo 2 -3 Baseline cycles (depending on whether the patient was an OC
      user before), during which menstrual pain, bleeding events, and pain killer intake have to be
      documented. During this observation period, the intake of hormonal contraceptives is not
      allowed. Other contraceptive methods (condoms with spermicide, pessary with spermicide) have
      to be used. If the patient is eligible for the study, she will be randomly assigned to one of
      the two treatment groups. Treatment group A will take the medication according to an extended
      flexible regimen, i.e., tablet intake will be triggered by bleeding events. Treatment group B
      will take the study medication in the 24 + 4 days regimen. That means, tablets to be taken on
      cycle days 1 - 24 contain the hormone combination, whereas tablets 25 - 28 do not contain any
      active ingredients, i.e., these are so called placebo tablets.

      Treatment will last at least 140 days, but can be prolonged in Treatment Group A depending of
      occurrence of menstrual bleeding. The overall study duration will be 10 months for each
      patient.

      During the whole study period, 5 visits are planned. At Screening and Final examination, a
      thorough physical examination and a gynecological examination (including breath palpation and
      cervical smear ) will be performed. Blood samples will be taken for safety laboratory
      parameters.

      Additional examinations can be performed any time, if this becomes necessary for medical
      reasons.

      Patients will be provided with a patient diary to document the intake of study medication,
      any bleeding events and days without bleeding, pregnancy test results, any dysmenorrheic
      (menstrual) pain and its intensity and its interference with daily activity, and intake of
      pain medication. The pain medication (ibuprofen) will be provided.
    


Intervention name(s): Drug: YAZ flex (SH T00186D); YAZ (SH T00186D)
Intervention type(s): Drug; Drug
Intervention description(s): Extended flexible regimen of YAZ (SH T00186D); triggered by bleeding events(Tablet p.o. (oral)); YAZ (SH T 00186D) administered in the conventional regimen (24 days active + 4 days placebo) (Tablet p.o. (oral))
Intervention MeSH terms: Drospirenone and ethinyl estradiol combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary Dysmenorrhea; Menstrual Pain; Oral Contraception