Efficacy and Safety,Long-term Study of Low-dose Oral Contraceptive Pill to Treat Dysmenorrhea.
Sponsor
Nobelpharma (Industry)
Overall Status
Completed
CT.gov ID
NCT00212277
Collaborator
(none)
24
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date
:
Feb 1, 2005
Actual Primary Completion Date
:
Sep 1, 2006
Actual Study Completion Date
:
Feb 1, 2007
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- dysmenorrhea associated with endometriosis
Exclusion Criteria:
-
severe hepatopathy
-
pregnant woman
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Nobelpharma
Investigators
- Study Director: Naoki Terakawa, M.D.,Ph.D., Tottori University,Tottori,Japan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00212277
Other Study ID Numbers:
- IKH-01-5
First Posted:
Sep 21, 2005
Last Update Posted:
Sep 10, 2010
Last Verified:
Sep 1, 2010
Additional relevant MeSH terms: