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

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.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00212342
Enrollment
100
Registered
2005-09-21
Start date
2004-12-31
Completion date
2006-03-31
Last updated
2010-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysmenorrhea

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.

Interventions

DRUGNorethisterone,Ethinylestradiol
DRUGSugar pill

Sponsors

Nobelpharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* dysmenorrhea associated with endometriosis

Exclusion criteria

* severe hepatopathy * pregnant woman

Design outcomes

Primary

MeasureTime frame
patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS—

Secondary

MeasureTime frame
changes in the VAS of non-menstrual pain.—
changes in the clinical evaluation of pelvic induration.—
changes in the size of ovarian endometrioma.—
changes in the VAS of dysmenorrhea.—
changes in the VRS of non-menstrual pain.—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026