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| Descriptive Information Fields | |||||||||
| Brief Title † | SH T00186 in the Treatment of Primary Dysmenorrhea | ||||||||
| 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 Ethinylestradiol as Beta-Cyclodextrin Clathrate and 3 mg Drospirenone) Compared to the Conventional Regimen of SH T00186D in the Treatment of Primary Dysmenorrhea | ||||||||
| 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 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. |
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| Detailed Description | |||||||||
| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Number of days with dysmenorrheic pain [ Time Frame: 140 days ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Use of rescue medication [ Time Frame: 140 days ] [ Designated as safety issue: No ] Interference with daily activity [ Time Frame: 140 days ] [ Designated as safety issue: No ] Number of days: with at least moderate dysmenorrheic pain; [ Time Frame: 140 days ] [ Designated as safety issue: No ] Number of days with pelvic pain [ Time Frame: 140 days ] [ Designated as safety issue: No ] Number of days with dysmenorrheic pain associated with withdrawal bleeding [ Time Frame: 140 days ] [ Designated as safety issue: No ] Number of days with dysmenorrheic pain associated with unscheduled bleeding [ Time Frame: 140 days ] [ Designated as safety issue: No ] Bleeding patterns [ Time Frame: Whole treatment period ] [ Designated as safety issue: Yes ] Assessment of treatment [ Time Frame: Whole treatment period ] [ Designated as safety issue: No ] |
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| Condition † | Primary Dysmenorrhea | ||||||||
| Intervention † | Drug: YAZ flex (SH T00186D) Drug: YAZ (SH T00186D) |
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| MEDLINE PMIDs | |||||||||
| Links | Click here and search for drug information provided by the FDA  Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product Click here to find results for studies related to marketed products |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 216 | ||||||||
| Start Date † | December 2007 | ||||||||
| Completion Date | December 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 40 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Germany, United Kingdom | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00569244 | ||||||||
| Organization ID | 91587 | ||||||||
| Secondary IDs †† | EudraCT No.: 2006-004899-13, 310882 | ||||||||
| Study Sponsor † | Bayer | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Bayer | ||||||||
| Verification Date | October 2008 | ||||||||
| First Received Date † | December 5, 2007 | ||||||||
| Last Updated Date | October 30, 2008 | ||||||||
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