Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea
|ClinicalTrials.gov Identifier: NCT00212342|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 8, 2010
|Condition or disease||Intervention/treatment||Phase|
|Dysmenorrhea||Drug: Norethisterone,Ethinylestradiol Drug: Sugar pill||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||March 2006|
|Experimental: Norethisterone,Ethinylestradiol||Drug: Norethisterone,Ethinylestradiol|
|Placebo Comparator: Sugar pill||Drug: Sugar pill|
- patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS
- changes in the VAS of dysmenorrhea.
- changes in the VRS of non-menstrual pain.
- changes in the VAS of non-menstrual pain.
- changes in the clinical evaluation of pelvic induration.
- changes in the size of ovarian endometrioma.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212342
|Study Director:||Naoki Terakawa, M.D.,Ph.D.||Tottori University,Tottori,Japan|