Principal Investigator: Karen Grewen, PhD, Department of Psychiatry, University of North Carolina, Chapel Hill

Recruitment Length: June 2013

Study Brief: Women with severe PMS or PMDD may be more sensitive to the normal hormonal fluctuations associated with their menstrual cycle. This study is designed to examine whether suppression of hormonal fluctuations with a continuous low-dose oral contraceptive will alleviate the cyclical fluctuations in mood symptoms that are triggered by increasing hormones in the premenstrual week. Women enrolled in this study will receive one of three interventions for three months: 1) continuous low dose oral contraceptive; 2) intermittent low dose oral contraceptive (three weeks of active pills and one week of inactive pills); or 3) placebo (all inactive pills). Women will have equal odds of being assigned to one of these three treatments. This study involves multiple study visits lasting 15 – 45 minutes. These visits may occur at UNC or at the participant’s home.

You may be qualified if the following applies to you:

1) you have cardiovascular disease

2) you have used either cocaine and/or marijuana and/or alcohol and/or nicotine (smoked cigarettes)

3) you have not used any drugs during pregnancy

4) you are pregnant or no more than 4 weeks postpartum

Factors that may exclude you from participating:

1) you have cardiovascular disease

2) you delivered before 36 weeks or later than 42 weeks gestation

3) your baby weighed less than 5.5 lbs

4) your pregnancy was multiple birth

Point of Contact: For more information, contact 919-966-2549 or motherbabylab@unc.edu

Compensation Available: Up to $300 or equivalent in Wal-Mart gift cards