Status:
COMPLETED
Continuous Oral Contraceptive Treatment in Premenstrual Dysphoric Disorder (PMDD)
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Premenstrual Dysphoric Disorder
Eligibility:
FEMALE
18-52 years
Phase:
PHASE4
Brief 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 (on...
Detailed Description
Premenstrual Dysphoric Disorder (PMDD) describes the cyclic appearance of affective symptoms and resultant impairment during the luteal phase of the menstrual cycle. The objective of this trial is to ...
Eligibility Criteria
Inclusion
- meets prospective criteria for PMDD, AND
- English speaking and reading skills.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00927095
Start Date
July 1 2008
End Date
July 1 2014
Last Update
August 24 2016
Active Locations (1)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599