Phase 3 N=115 Randomized Triple-blind Treatment

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

Dysmenorrhea

Bottom Line

View on ClinicalTrials.gov: NCT00746096 ↗

Enrolled (actual)

115

Serious AEs

0.0%

Results posted

Jun 2014

Primary outcome: Primary: Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) — 3.8; 3.6; 1.2; 2.2 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: IKH-01 (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: Female
Sponsor: Nobelpharma
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)	3.8; 3.6; 1.2; 2.2	—
SECONDARY Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment)	57.2; 60.0; 21.2; 39.2	—

Summary

The purpose of this study is to determine whether combination oral contraceptive pill of norethindrone and ethinyl estradiol is effective in the treatment of primary dysmenorrhea.

Eligibility Criteria

Inclusion Criteria

primary dysmenorrhea

Exclusion Criteria

severe hepatopathy
pregnant woman

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00746096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.