Back to resultsEfficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea
Primary Purpose
Dysmenorrhea
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Norethisterone,Ethinylestradiol
Sugar pill
Sponsored by
About this trial
This is an interventional treatment trial for Dysmenorrhea
Eligibility Criteria
Inclusion Criteria: dysmenorrhea associated with endometriosis Exclusion Criteria: severe hepatopathy pregnant woman
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Norethisterone,Ethinylestradiol
Sugar pill
Arm Description
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nobelpharma
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Norethisterone,Ethinylestradiol
Arm Type
Experimental
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Norethisterone,Ethinylestradiol
Intervention Type
Drug
Intervention Name(s)
Sugar pill
Primary Outcome Measure Information:
Title
patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS
Secondary Outcome Measure Information:
Title
changes in the VAS of dysmenorrhea.
Title
changes in the VRS of non-menstrual pain.
Title
changes in the VAS of non-menstrual pain.
Title
changes in the clinical evaluation of pelvic induration.
Title
changes in the size of ovarian endometrioma.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
dysmenorrhea associated with endometriosis
Exclusion Criteria:
severe hepatopathy
pregnant woman
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naoki Terakawa, M.D.,Ph.D.
Organizational Affiliation
Tottori University,Tottori,Japan
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea
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