Phase 3
Completed N=115
Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea
Source: ClinicalTrials.gov NCT00746096 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: 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
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.
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 | — |
Eligibility Criteria
Inclusion Criteria
- primary dysmenorrhea
Exclusion Criteria
- severe hepatopathy
- pregnant woman
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. Informational only — not medical advice.