Continuous Oral Contraceptive Treatment in Premenstrual Dysphoric Disorder (PMDD)

Completed · Phase 4 · Has a placebo group

Conditions studied: Premenstrual Dysphoric Disorder

In brief

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.

Key facts

Study ID: NCT00927095
Run by: University of North Carolina, Chapel Hill
People needed: 67
Starts: 2008-07-01
Expected to finish: 2014-07-01
Last updated by the study team: 2016-08-24

Who can join

Age: 18 and older, up to 52. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

meets prospective criteria for PMDD, AND
English speaking and reading skills.

You may not qualify if…

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.

Where it is running

University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.