Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|