Clinical Trial: SH T00186 in the Treatment of Primary Dysmenorrhea

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-center, Open-label, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of an Extended Flexible Regimen of the Combined Oral Contraceptive SH T00186D (0.02 mg Ethinylest

Brief 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 cer

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: Number of days with dysmenorrheic pain [ Time Frame: 140 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Use of rescue medication [ Time Frame: 140 days ]
  • Interference with daily activity [ Time Frame: 140 days ]
  • Number of days: with at least moderate dysmenorrheic pain [ Time Frame: 140 days ]
  • Number of days with pelvic pain [ Time Frame: 140 days ]
  • Number of days with dysmenorrheic pain associated with withdrawal bleeding [ Time Frame: 140 days ]
  • Number of days with dysmenorrheic pain associated with unscheduled bleeding [ Time Frame: 140 days ]
  • Bleeding patterns [ Time Frame: Whole treatment period ]
  • Assessment of treatment [ Time Frame: Whole treatment period ]


Original Secondary Outcome:

  • Use of rescue medication [ Time Frame: 140 days ]
  • Interference with daily activity [ Time Frame: 140 days ]
  • Number of days: with at least moderate dysmenorrheic pain; with pelvic pain; associated with withdrawal bleeding; associated with unscheduled bleeding [ Time Frame: 140 days ]


Information By: Bayer

Dates:
Date Received: December 5, 2007
Date Started: December 2007
Date Completion:
Last Updated: October 28, 2014
Last Verified: October 2014