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

Abstract

To 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. Design Single-centre, double-blind, randomized, placebo-controlled study. Population Two hundred and twenty-three healthy postmenopausal women, aged between 40 and 60 years and complaining of severe menopausal symptoms were recruited through newspaper advertisements. Women were randomly allocated to progestelle progesterone cream 60, 40, 20, 5 mg or placebo, to be applied daily for six months. Main outcome measures The 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. Adverse events were sought and recorded and followed up to resolution. There were no statistically significant differences between any of the treatment groups and placebo for any of the components of the Greene Score. A statistically significant difference between the 20 mg group and placebo was found for the physical functioning (95% confidence interval [CI] 1.7-12.3; P=0.01) and social functioning (95% CI 1.9-16.7; P=0.01) scales of SF-36 after six months. No other statistically significant differences were found between any treatment group and placebo for any of the other secondary efficacy variables. There appeared to be a higher incidence of headache in the groups treated with progesterone cream. Progesterone cream was no more effective than placebo for relief of menopausal symptoms.