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Clinical Trial Name - Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea
| Original Study ID : IKH-01-4 |
| NCT ID : NCT00212342 |
| Brief Title : Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea |
| Official Title : Phase 3,Placebo Controlled,Randomized,Double-Blinded,NSAID-Add-on,Clinical Trial of Mono-Phase Low Dose Oral Contraceptive Pill for Treatment of Dysmenorrhea Associated With Endometriosis. |
| Brief Summary : The purpose of this study is to determine whether combination oral contraceptive pill of Norethindrone & Ethinyl estradiol is effective in the treatment of dysmenorrhea associated with endometriosis. |
| Source : Nobelpharma |
| Overall Status : Completed |
| Official Title : Phase 3 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Verification Date : May 2009 |
| First Received Date : September 13, 2005 |
| Trial Eligibility |
| Criteria : Inclusion Criteria: - dysmenorrhea associated with endometriosis Exclusion Criteria: - severe hepatopathy - pregnant woman |
| Gender : Female |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| OutComes |
| Primary OutComes |
| Measure : patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS |
| Secondary OutComes |
| Measure : changes in the VAS of dysmenorrhea. |
| Measure : changes in the VRS of non-menstrual pain. |
| Measure : changes in the VAS of non-menstrual pain. |
| Measure : changes in the clinical evaluation of pelvic induration. |
| Measure : changes in the size of ovarian endometrioma. |
| Interventions |
| Type : Drug |
| Name : Norethindrone,Ethinyl Estradiol |
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