Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea
Sponsor
Nobelpharma (Industry)
Overall Status
Completed
CT.gov ID
NCT00212342
Collaborator
(none)
100
2
14.9
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, 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.
Study Start Date
:
Dec 1, 2004
Actual Primary Completion Date
:
Jan 1, 2006
Actual Study Completion Date
:
Mar 1, 2006
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Norethisterone,Ethinylestradiol
|
Drug: Norethisterone,Ethinylestradiol
|
| Placebo Comparator: Sugar pill
|
Drug: Sugar pill
|
Outcome Measures
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. []
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:
NCT00212342
Other Study ID Numbers:
- IKH-01-4
First Posted:
Sep 21, 2005
Last Update Posted:
Sep 8, 2010
Last Verified:
Sep 1, 2010