PERCUTANEOUS ESTRADIOL GEL WITH AN INTRAUTERINE LEVONORGESTREL RELEASING DEVICE OR NATURAL PROGESTERONE IN HORMONE REPLACEMENT THERAPY

Objective: To evaluate the bleeding patterns and clinical compliance a ssociated with postmenopausal amenorrhea-inducing forms of hormone rep lacement therapy using either percutaneous estradiol-gel and a levonor gestrel-releasing intrauterine device or an oral/vaginal natural proge sterone. Methods: Sixty postmenopausal women with an intact uterus wer e followed over 12 months in this open, non-randomised, parallel group study. All patients continuously received a gel containing 1.5 mg of estradiol daily. The women were divided into three groups on the basis of progestin administration. Twenty women (group I) had a levonorgest rel-releasing device (LNG-IUD) inserted at the beginning of the study. Twenty-one women (group II) received oral natural micronised progeste rone (oral P) 100 mg daily during 25 calendar days each month, and 19 women (group III) used vaginal natural micronised progesterone (vagina l P) 100-200 mg daily during 25 calendar days each month (higher dose if spotting occurred). Clinic visits were at 0, 3, 6 and 12 months. Bl eeding patterns were recorded by the patient in a diary and clinical c ompliance was evaluated at control visits during the treatment. Sympto ms were recorded using a modified Kuppermann index. The serum estradio l concentration was determined at the 0, 6 and 12 month control visits . Results: 80% (n = 16) of the patients in the LNG-IUD group, 67% (n = 14) in the oral P group II and 53% (n = 10) in the vaginal P group we re without bleeding at 12 months. Spotting was common during the first 3 months. Symptom relief was good in each group. The LNG-IUD did not cause any serious side-effects. Compliance was good for LNG-IUD and or al progesterone but not for vaginal progesterone. Conclusions: Percuta neous estradiol-gel associated with LNG-IUD is an appropriate method o f hormone replacement therapy. The combination of oral natural progest erone with estradiol-gel is also useful, although bleeding episodes co mplicated the treatment in one third of the patients. The vaginal admi nistration of natural progesterone was impractical due to bleeding dis orders. (C) 1997 Elsevier Science Ireland Ltd.