Oral medroxyprogesterone acetate and combination oral contraceptives for acute uterine bleeding: a randomized controlled trial.
Author(s): Munro MG, Mainor N, Basu R, Brisinger M, Barreda L
Affiliation(s): Department of Obstetrics, Kaiser Permanente Southern California Los Angeles Medical Center, Los Angeles, Los Angeles, California, USA. M.G.Munro@kp.org
Publication date & source: 2006-10, Obstet Gynecol., 108(4):924-9.
Publication type: Randomized Controlled Trial
OBJECTIVE: To compare the efficacy of multidose medroxyprogesterone acetate and a multidose monophasic combined oral contraceptive (OC) for hemodynamically stable women with nongestational, acute uterine bleeding. METHODS: Hemodynamically stable patients with acute uterine bleeding sufficient to justify immediate medical or surgical intervention were enrolled in an open-label, randomized trial comparing oral medroxyprogesterone acetate 20 mg and a monophasic combination OC containing 1 mg norethindrone and 35 mug of ethinyl estradiol, each administered three times per day. Doses were reduced after 1 week to 20 mg per day and one tablet per day for the next 3 weeks for the medroxyprogesterone acetate and OC groups, respectively. Following baseline assessment, patients completed daily treatment and symptom logs collected at 14 and 28 days after initiation of therapy. RESULTS: Forty patients were randomly assigned, 20 in each group; 33 were evaluated at the 14-day visit. Emergency surgical procedures were avoided in 100% of those women taking medroxyprogesterone acetate and 95% of the OC group. Cessation of bleeding had occurred in 88% of the OC group and 76% of those receiving medroxyprogesterone acetate, with a median time to bleeding cessation of 3 days for both groups. Compliance with therapy was higher in the medroxyprogesterone acetate group than the OC group, but there was no overall difference in the incidence of treatment-related nausea and bloating. CONCLUSION: This randomized trial is limited by sample size but suggests that both regimens may be effective and reasonably well tolerated. CLINICAL TRIAL REGISTRATION: Current Clinical Trials (clinicaltrials.gov, www.clinicaltrials.gov) Identifier: NCT00350480 LEVEL OF EVIDENCE: II-1.
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