Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Contraceptive Agents; Contraceptives, Oral; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Gestodene; Polyestradiol phosphate

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.