Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea

Phase 3

Completed

• Conditions: Dysmenorrhea
• Interventions: Drug: Norethisterone,Ethinylestradiol; Drug: Sugar pill

• Registration Number: NCT00212342
• Lead Sponsor: Nobelpharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2006-01
• Study Completion: 2006-03
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-06
• Last Update Posted: 2010-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• dysmenorrhea associated with endometriosis

Exclusion Criteria

• severe hepatopathy
• pregnant woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Norethisterone,Ethinylestradiol	Norethisterone,Ethinylestradiol	-
Sugar pill	Sugar pill	-

Primary Outcome Measures

Name	Time	Method
patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS

Secondary Outcome Measures

Name	Time	Method
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.