Combined Oral Contraception and Bicalutamide in Polycystic Ovary Syndrome and Severe Hirsutism - a Double-blind RTC.

Combined Oral Contraception and Bicalutamide in Polycystic Ovary Syndrome and Severe Hirsutism - a Double-blind RTC.

J Clin Endocrinol Metab. 2017 Dec 01;:

Authors: Moretti C, Guccione L, Di Giacinto P, Simonelli I, Exacoustos C, Toscano V, Motta C, De Leo V, Petraglia F, Lenzi A

Abstract
Background: Hirsutism is frequently expressed in women affected by polycystic ovary syndrome (PCOS). The efficacy of oral contraceptive pill (OC) plus anti-androgens in the treatment of its severe expression is controversial due to the lack of randomized double-blind long-term studies.
Aim: The primary outcome was the reduction of hirsutism in PCOS women objectively measured by videodermoscopy (VD) on the androgen-sensitive skin areas assessed by the modified Ferriman&Gallwey (mF&G) total score, after 12 months of therapy with OC+Bicalutamide (BC) versus OC plus placebo (P). The secondary outcomes were to evaluate tolerability of bicalutamide and body composition as well as the occurrence of adverse events.
Design: This was an experimental, phase III, prospective, multicenter, randomized, double-blind, placebo-controlled trial. Patients were evaluated at the baseline visit, at the sixth and twelfth month during treatment and six months after its end.
Population study: 70 women with classic PCOS (severe hirsutism, oligo-anovulation and ovarian PCO morphology) were evaluated.
Treatment protocols: Patients received a therapy with OCP+BC (50mg/die) or OCP+P for 12 months.
Results: The RM-ANOVA showed that both treatments were effective in reducing hirsutism: the OCP+BC group had a higher reduction compared to the OCP+P group. No adverse effects were described during treatment except an increase in total cholesterol and LDL in the OCP+BC group.
Conclusions: The association of OCP+BC is well tolerated and significantly more effective than OCP alone in treating severe hirsutism. Furthermore, we suggest a combined use of VDI and mF&G to evaluate correctly the effects of androgen deprivation therapy for hirsutism.

PMID: 29211888 [PubMed - as supplied by publisher]

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