Continuous Oral Contraceptive Treatment in Premenstrual Dysphoric Disorder (PMDD)

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to compare a low dose oral contraceptive (OC) given continuously (every day for three months) with the same low dose oral contraceptive given in an interrupted regimen (one week of inactive placebo pills each month) and with continuous placebo (inactive placebo given every day for three months). The primary hypothesis is that continuous OC will be significantly more effective in reducing premenstrual symptoms compared with either the interrupted OC or continuous placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Contraceptive Agents; Contraceptives, Oral; Drospirenone and ethinyl estradiol combination

Criteria

Inclusion Criteria:

• meets prospective criteria for PMDD, AND

• English speaking and reading skills.

Exclusion Criteria:

• current psychiatric disorder other than PMDD,

• history of venous thromboembolism,

• over 35 years of age and obese,

• uncontrolled hypertension or end-organ vascular disease,

• diabetes,

• migraine headache with aura,

• breastfeeding or pregnant,

• cigarette smoking,

• family history of premenopausal breast cancer or breast cancer in more than one first degree relative,

• elevated serum potassium levels, use of prescription medications (except stable thyroid supplementation),

• irregular menstrual cycles, OR

• history of: endometriosis, hepatic disease, breast carcinoma, pulmonary embolism or phlebothrombosis, malignant melanoma, cholecystitis or pancreatitis.