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.
RCT Entities:
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.
Authors: Kristen A Matteson; Christina A Raker; Stephanie B Pinto; Dana Marie Scott; Gary N Frishman Journal: J Reprod Med Date: 2012 Jan-Feb Impact factor: 0.142
Authors: Anne Lethaby; Michelle R Wise; Maria Aj Weterings; Magdalena Bofill Rodriguez; Julie Brown Journal: Cochrane Database Syst Rev Date: 2019-02-11
Authors: Ozgul Muneyyirci-Delale; Anuja Gupta; Cynthia Abraham; Ashadeep Chandrareddy; Charles H Bowers; Jed B Cutler Journal: Int J Womens Health Date: 2010-09-01