Combining an estrogen-progesterone oral contraceptive pill (OCP) with the anti-androgen bicalutamide is more effective than an OC alone in treating severe hirsutism in women with polycystic ovary syndrome (PCOS), according to a double-blind randomized controlled trial from Italy.

Drug treatment for severe hirsutism is largely based on using OCP as monotherapy or in association with anti-androgens, note Dr. Costanzo Moretti from the University of Rome TorVergata and colleagues in their report, online in the Journal of Clinical Endocrinology & Metabolism.

“However, the treatment of patients suffering from significant hirsutism with combined estro-progestin plus anti-androgen therapy is still a subject for debate because of a lack of double-blind controlled studies designed to establish the required length, effectiveness, and safety of treatment to reduce hirsutism,” they point out.

In the current trial, women with classic PCOS (severe hirsutism, oligo-anovulation, and ovarian PCO morphology) were randomly allocated to a combined OCP plus 50 mg/day bicalutamide (BC) or OCP plus placebo for 12 months. There were 35 women in each group. They were evaluated at baseline and at six and 12 months during treatment – and six months after treatment ended.

To correctly assess the efficacy of anti-androgen therapy in hirsutism, note the researchers, they used a novel videodermoscopy technique to quantify the number and density of hair follicles in androgen-dependent skin areas by establishing a “videodermoscopic index” (VDI) score.

“This study shows that both OCP and anti-androgen bicalutamide in association with OCP were effective in reversing severe hirsutism in hyperandrogenic women affected by PCOS,” the investigators report. Through hair follicle, count and VDI score they were able to show that when BC is added to OCP the efficacy is “significantly improved” compared to OCP alone, they add.

They also say the overall condition of the women “seemed to improve not only because of the remission of the androgen excess symptoms, which was statistically significant but also because of relief from psychological distress.”

Bicalutamide used in combination with OCP was well tolerated, they say, based on monitoring the women for 18 months for blood pressure, fasting insulin and glucose, waist circumference, with blood tests for liver and kidney function and all the metabolic parameters. “The only important parameter to be monitored is cholesterol,” they say, which increased more in women treated with OCP and BC.

During the 12 months of treatment, there were no significant statistical changes in fat mass and percentage of trunk fat between the two study groups, and no statistically significant weight gain.

Dr. Moretti et al. conclude, this study provides evidence that either OCP alone and in combination with an anti-androgen are “useful therapeutic options” to reduce hirsutism. “The anti-androgen bicalutamide combined with OCP seems to be more efficacious compared to OCP alone and is suggested as an excellent treatment for severe hirsutism,” they add.