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

Dysmenorrhea Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212342
• Other study ID #: IKH-01-4
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 6, 2010
• Start date: December 2004
• Est. completion date: March 2006

Study information

• Verified date: September 2010
• Source: Nobelpharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• dysmenorrhea associated with endometriosis

Exclusion Criteria:

• severe hepatopathy

• pregnant woman

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Drug:
• Norethisterone,Ethinylestradiol

• Sugar pill

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nobelpharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS
Secondary	changes in the VAS of dysmenorrhea.
Secondary	changes in the VRS of non-menstrual pain.
Secondary	changes in the VAS of non-menstrual pain.
Secondary	changes in the clinical evaluation of pelvic induration.
Secondary	changes in the size of ovarian endometrioma.