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 morphologic features and withdrawal bleeding

Michelle P. Warren, Beverly M. K. Biller, Mona M. Shangold
In: American Journal of Obstetrics and Gynecology · 1999 · vol. 180(1) , pp. 42–48 · doi:10.1016/s0002-9378(99)70147-x · PMID:9914576 · W2045944726
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Cyclic administration of sustained-release vaginal progesterone gel (Crinone 4% and 8%) successfully induced endometrial changes and withdrawal bleeding in women experiencing secondary amenorrhea.

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Abstract

ObjectiveThe objective of this study was to evaluate the safety and efficacy of 2 doses of a transvaginal polycarbophil-based progesterone gel (4% and 8%) in hormone replacement therapy.Study designThis multicenter, randomized, parallel-group, open-label 3-month study included 127 women with secondary amenorrhea. Estrogenized patients applied transvaginal progesterone (4% or 8%) every other day for 6 doses per month. Efficacy was based on endometrial biopsy findings and withdrawal bleeding. McNemar's test was used to compare incidence of adverse events before and during treatment.ResultsProgestational changes were found in 92% (Crinone 4%) and 100% (Crinone 8%) of patients with evaluable biopsies. Withdrawal bleeding was experienced by 81% (Crinone 4%) and 82% (Crinone 8%) of the patients. No patient experienced any serious side effect related to treatment. The incidence of most side effects, including psychologic symptoms, decreased with progesterone treatment compared with estrogen alone therapy. Compliance exceeded 98% for both doses.ConclusionsCrinone is a novel, effective, and well-tolerated option for hormone replacement therapy in women with secondary amenorrhea.

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