UNC Testing Oral Contraceptives for Severe PMS

The University of North Carolina (UNC) at Chapel Hill has been granted $3 million from the National Institute of Mental Health to undertake a five-year clinical trial of a low-dose contraceptive as treatment for premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome (PMS) that affects between 5% and 10% of all women reporting symptoms of PMS. PMDD can cause major disruptions to a woman’s life, in ways that resemble people battling major depressive episodes, anxiety disorders, and even post-traumatic stress disorder (PTSD).

Every month, women with PMDD experience uncomfortable physical conditions that include low energy, heart palpitations, bloating, and pain in the joints and muscles. Perhaps even more distressing are the emotional symptoms which include anxiety, depression, difficulty focusing, irritability, mood swings, and sleep disruptions. Women with PMDD experience no less than five of these symptoms during the week before menstruation begins. Once menstruation begins each month, the symptoms go away.

It is believed that women with PMDD do not necessarily have extreme levels of reproductive hormones but that they are more sensitive to the normal fluctuations of hormones that occur over the course of the menstrual cycle. The UNC research team suggests it’s the sensitivity to the fluctuation that generates the emotional symptoms.

David Rubinow, MD, will lead the study involving three groups of 27 women each. Rubinow is a professor and chair of psychiatry at UNC’s School of Medicine.

Each woman in the study will take one of three treatment options – a 28-day cycle of oral contraceptives designed to be taken every day, a 21-7 cycle of contraceptives designed to mimic the natural hormone cycle, and a placebo – for a three-month study period. Researchers will measure hormone levels throughout the women’s cycles and they will measure progesterone metabolites, as well.

Progesterone metabolites are active regulators of emotion and mood. The research team suggests eliminating the metabolites may bring tremendous benefits to women suffering from PMDD. One theory held by the research team is that eliminating the cycling of reproductive hormones will eliminate the debilitating symptoms of PMDD.

Current treatment for PMDD often involves selective serotonin reuptake inhibitors (SSRIs) and other forms of antidepressants but as many as 40% of the women who try antidepressants don’t get significant relief of symptoms. The research team hopes to find an alternative treatment that comes with fewer risks than antidepressant medications do.

Source: University of North Carolina School of Medicine