Intrauterine release of levonorgestrel--a new way of adding progestogen in hormone replacement therapy.

Forty perimenopausal women with climacteric complaints were randomly allocated to one of two estrogen-progestogen regimens. One group was treated cyclically for 3-week periods with 2 mg of estradiol (E2) valerate; during the last 10 days 250 micrograms of levonorgestrel was added. Another group was given 2 mg of E2 valerate a day and had a 20-micrograms/24-hour levonorgestrel-releasing intrauterine device (IUD) inserted. The study period was 1 year. Climacteric symptoms, bleeding patterns, and endometrial histopathology were recorded during the study. Subjective symptoms were equally diminished in both groups. In the IUD group, bleeding disturbances were gradually reduced, and 15 of 18 women became amenorrheic after 12 months, compared with the group given cyclic treatment in which all women bled regularly. No endometrial proliferation was found in any woman after 12 months. Thus, intrauterine release of 20 micrograms of levonorgestrel per day, in combination with orally administered E2, prevented endometrial proliferation and reduced uterine bleeding. This new approach to continuous combined hormone replacement therapy may be a well-tolerated treatment alternative in perimenopausal women.

RCT Entities:   Population Interventions Outcomes