Phase 2
N=38
Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea
Dysmenorrhea
Bottom Line
View on ClinicalTrials.gov: NCT00517556 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Change in Visual Analog Scale (VAS) Score — -74.8; -58.7 units on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CCOCP (Drug); Traditional OCP (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Visual Analog Scale (VAS) Score |
-74.8; -58.7 | 0.05 |
Summary
The primary hypothesis is that continuous administration of an OCP (CCOCP regimen) will result in more pain relief than a traditional 21/7 administration in primary dysmenorrhea (PD) patients.
Eligibility Criteria
Inclusion Criteria
- Healthy women ages 18-35 with a history of PD (onset < 3 years after menarche).
- Subjects must have had regular (25-31 day) menstrual cycles for the three month period preceding enrollment, with symptoms of moderate to severe PD during those cycles.
Exclusion Criteria
- Patients who have contraindications to OCP therapy.
- Known or suspected secondary dysmenorrhea (major abdominal or pelvic surgery, endometriosis, pelvic inflammatory disease (PID), ovarian cysts, pathological vaginal secretion, chronic abdominal pain, inflammatory bowel disease, irritable bowel syndrome).
- Concomitant treatment with oral contraceptives, GnRH agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs.
- The use of contraceptive implants, injectable contraceptives or intrauterine devices. The washout period on all these medications will be 3 months.
- Migraines, depression requiring hospitalization or associated with suicidal ideation during previous estrogen or ocp use.
- Known or suspected hypersensitivity to trial drug.
- Patients enrolled simultaneously into other investigative studies that require meds.
Data sourced from ClinicalTrials.gov (NCT00517556). 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.