A new clinical option for hormone replacement therapy in women with secondary amenorrhea: Effects of cyclic administration of progesterone from the sustained-release vaginal gel Crinone (4% and 8%) on endometrial morphologicfeatures and withdrawal bleeding

OBJECTIVE: The objective of this study was to evaluate the safety and effic acy of 2 doses of a transvaginal polycarbophil-based progesterone gel (4% a nd 8%) in hormone replacement therapy. STUDY DESIGN: This multicenter, randomized, parallel-group, open-label 3-mo nth study included 127 women with secondary amenorrhea. Estrogenized patien ts applied transvaginal progesterone (4% or 8%) every other day for 6 doses per month. Efficacy was based on endometrial biopsy findings and withdrawa l bleeding. McNemar's test was used to compare incidence of adverse events before and during treatment. RESULTS: Progestational changes were found in 92% (Crinone 4%) and 100% (Cr inone 8%) of patients with evaluable biopsies. Withdrawal bleeding was expe rienced by 81% (Crinone 4%) and 82% (Crinone 8%) of the patients. No patien t experienced any serious side effect related to treatment. The incidence o f most side effects, including psychologic symptoms, decreased with progest erone treatment compared with estrogen alone therapy. Compliance exceeded 9 8% for both doses. CONCLUSIONS: Crinone is a novel. effective, and well-tolerated option for h ormone replacement therapy in women with secondary amenorrhea.