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J Clin Endocrinol Metab. 2018 Mar 1;103(3):824-838. doi: 10.1210/jc.2017-01186.

Combined Oral Contraception and Bicalutamide in Polycystic Ovary Syndrome and Severe Hirsutism: A Double-Blind Randomized Controlled Trial.

Author information

Department of Systems' Medicine, Unit of Endocrinology, Section of Reproductive Endocrinology, "San Giovanni Calibita" Hospital, University of Rome Tor Vergata, Rome, Italy.
Service of Medical Statistics & Information Technology, Fatebenefratelli Foundation for Health Research and Education, Rome, Italy.
Department of Surgery, Unit of Obstetrics and Gynecology, University of Rome Tor Vergata, Rome, Italy.
Unit of Endocrinology, Sant'Andrea Hospital, II Faculty of Medicine, University of Rome "Sapienza," Rome, Italy.
Unit of Obstetrics and Gynecology, "Santa Maria alle Scotte" Hospital, University of Siena, Siena, Italy.
Department of Experimental Medicine, Unit of Endocrinology, "Policlinico Umberto I" Hospital, University of Rome "Sapienza," Rome, Italy.



Hirsutism often occurs in women with polycystic ovary syndrome (PCOS). The efficacy of oral contraceptive pill (OCP) plus antiandrogens in the treatment of its severe expression is controversial due to the lack of randomized, double-blind, long-term studies.


The primary outcome was the reduction of hirsutism in PCOS women objectively measured by videodermoscopy on the androgen-sensitive skin areas assessed by the modified Ferriman and Gallwey (mF&G) total score, after 12 months of therapy with OCP + bicalutamide (BC) vs OCP plus placebo (P). The secondary outcomes were to evaluate tolerability of BC and body composition as well as the occurrence of adverse events.


An experimental, phase 3, prospective, multicenter, randomized, double-blind, P-controlled trial. Patients were evaluated at the baseline visit, at 6 and 12 months during treatment, and 6 months' posttreatment.


Seventy women with classic PCOS (severe hirsutism, oligoanovulation, and ovarian polycystic ovarian morphology).


Patients received OCP + BC (50 mg/d) or OCP + P for 12 months.


The repeated measures analysis of variance showed that both treatments were effective in reducing hirsutism: The OCP + BC group had a higher reduction compared with the OCP + P group. No adverse effects were described during treatment except an increase in total cholesterol and low-density lipoprotein in the OCP + BC group.


The association of OCP + BC is well tolerated and significantly more effective than OCP alone in treating severe hirsutism. We suggest a combined use of the videodermoscopic index and mF&G to evaluate the effects of androgen deprivation therapy for hirsutism.

[Indexed for MEDLINE]

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