Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea
This study has been completed.
Information provided by:
First received: September 13, 2005
Last updated: September 6, 2010
Last verified: September 2010
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.
Drug: Sugar pill
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Nobelpharma:
Primary Outcome Measures:
- patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS
Secondary Outcome Measures:
- 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.
|Study Start Date:||December 2004|
|Study Completion Date:||March 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
|Experimental: Norethisterone,Ethinylestradiol||Drug: Norethisterone,Ethinylestradiol|
|Placebo Comparator: Sugar pill||Drug: Sugar pill|
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