ABSTRACT
OBJECTIVE: To investigate tolerability and efficacy of nomegestrol acetate, a new 19-nor-progesterone derivative, in the treatment of oligomenorrhea and amenorrhea; to compare this drug with didrogesteron, a widely-used spatial isomer of progesterone. METHODS: 56 women, aged 22 to 50, affected by menstrual disorders or premenstrual syndrome, entered the study. They were divided in two homogeneous groups by randomization. In the first group nomegestrol acetate was administered 5 mg daily per os; in the second group patients were treated by the usual didrogesteron dose, that is 10 mg twice a day per os; both treatments were administered for 10 days from day 16, during three consecutive menstrual cycles. Efficacy, compliance and biological tolerance were evaluated. RESULTS: 24 patients in the group treated by nomegestrol acetate and 22 in the group treated by didrogesteron completed the study. After the first cycle of therapy, nomegestrol acetate showed a higher efficacy in reducing menstrual loss; results are statistically homogeneous in the two groups at the end of the study. There were no reports of pain in both the groups. Evaluation of biological and clinical parameters at the end of the study did not show significant modifications in any subject. CONCLUSIONS: Nomegestrol acetate is an innovative and efficient molecule in the treatment of menstrual disorders. A good response to the drug is evident in a short time and with very low doses; its good compliance, if compared with other progesteron-derivatives, indicates nomegestrol acetate as a first-line therapy for polymenorrhea, olygomenorrhea and premenstrual syndrome.