A double-blind placebo-controlled study to evaluate the effect of progestelle progesterone cream on postmenopausal women

ObjectiveTo evaluate the effect on climacteric symptoms and quality of life, and the safety of four doses of progestelle progesterone cream administered for 24 weeks to postmenopausal women complaining of moderate to severe menopausal symptoms.DesignSingle-centre, double-blind, randomized, placebo-controlled study.PopulationTwo hundred and twenty-three healthy postmenopausal women, aged between 40 and 60 years and complaining of severe menopausal symptoms were recruited through newspaper advertisements.MethodsWomen were randomly allocated to progestelle progesterone cream 60, 40, 20, 5 mg or placebo, to be applied daily for six months.Main outcome measuresThe primary efficacy variable was the psychological, somatic and vasomotor components of the Greene Climacteric Scale after six months. Secondary endpoints were incidence of hot flushes and night sweats, the nine subscales of the Medical Outcome Survey Short Form-36 (SF-36), serum progesterone, endometrial thickness and histology after six months. Advers...