STUDY OBJECTIVE: To compare uterine size reduction obtained with three monthly subcutaneous injections of 3.6 mg of goserelin versus a single subcutaneous injection of 10.8 mg. DESIGN: Prospective, randomized clinical trial (Canadian Task Force classification I). SETTING: Department of Gynecology and Obstetrics at the Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo. PATIENTS: Forty-five premenopausal women with uterine leiomyomas and uterine size greater than 600 cm(3) randomized to one of two groups. INTERVENTION: Group A: 23 women received three monthly subcutaneous 3.6-mg doses of goserelin. Group B: 22 women received a single subcutaneous injection of 10.8 mg of goserelin. Follicle-stimulating hormone (FSH), estradiol, and hemoglobin levels were measured monthly. After 3 months, uterine size was determined by transvaginal and/or abdominal ultrasound. MEASUREMENTS AND MAIN RESULTS: In group A, mean reduction of uterine size was 43% (426 cm(3)) at the end of treatment. In Group B, mean reduction of uterine size was 54% (494 cm(3)). Serum levels of FSH and estradiol were in postmenopausal range during treatment. Hemoglobin level improvement was equivalent in both groups. CONCLUSION: Use of single injection of 10.8 mg of goserelin promoted significantly greater reduction in uterine size than three monthly 3.6-mg injections in patients with voluminous uterine leiomyomas.
RCT Entities:
STUDY OBJECTIVE: To compare uterine size reduction obtained with three monthly subcutaneous injections of 3.6 mg of goserelin versus a single subcutaneous injection of 10.8 mg. DESIGN: Prospective, randomized clinical trial (Canadian Task Force classification I). SETTING: Department of Gynecology and Obstetrics at the Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo. PATIENTS: Forty-five premenopausal women with uterine leiomyomas and uterine size greater than 600 cm(3) randomized to one of two groups. INTERVENTION: Group A: 23 women received three monthly subcutaneous 3.6-mg doses of goserelin. Group B: 22 women received a single subcutaneous injection of 10.8 mg of goserelin. Follicle-stimulating hormone (FSH), estradiol, and hemoglobin levels were measured monthly. After 3 months, uterine size was determined by transvaginal and/or abdominal ultrasound. MEASUREMENTS AND MAIN RESULTS: In group A, mean reduction of uterine size was 43% (426 cm(3)) at the end of treatment. In Group B, mean reduction of uterine size was 54% (494 cm(3)). Serum levels of FSH and estradiol were in postmenopausal range during treatment. Hemoglobin level improvement was equivalent in both groups. CONCLUSION: Use of single injection of 10.8 mg of goserelin promoted significantly greater reduction in uterine size than three monthly 3.6-mg injections in patients with voluminous uterine leiomyomas.
Authors: Rafael M Moroni; Wellington P Martins; Rui A Ferriani; Carolina S Vieira; Carolina O Nastri; Francisco José Candido Dos Reis; Luiz Gustavo Brito Journal: Cochrane Database Syst Rev Date: 2015-03-20