Back to resultsEfficacy and Safety,Long-term Study of Low-dose Oral Contraceptive Pill to Treat Dysmenorrhea.
Primary Purpose
Dysmenorrhea
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Norethindrone,Ethinyl Estradiol
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
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00212277
Brief Title
Efficacy and Safety,Long-term Study of Low-dose Oral Contraceptive Pill to Treat Dysmenorrhea.
Official Title
Phase3,Open-label,Long-term,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
February 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nobelpharma
4. Oversight
5. Study Description
Brief Summary
The purpose of this long-term study is to determine whether combination oral contraceptive pill of Norethindrone & Ethinyl estradiol is effective in the treatmentof 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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Norethindrone,Ethinyl Estradiol
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,Long-term Study of Low-dose Oral Contraceptive Pill to Treat Dysmenorrhea.
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