Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT00517556
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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT00517556
Study Brief:
Protocol Section:
NCT00517556