Oral medroxyprogesterone acetate and combination oral contraceptives for acute uterine bleeding: a randomized controlled trial.

Abstract

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: Malcolm G Munro, Nakia Mainor, Romie Basu, Mikael Brisinger, Lorena Barreda
• Journal: Obstetrics and gynecology (Obstet Gynecol) Vol. 108 Issue 4 Pg. 924-9 (Oct 2006) ISSN: 0029-7844 [Print] United States
• PMID: 17012455 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Contraceptive Agents, Female
• Contraceptives, Oral, Combined
• Medroxyprogesterone Acetate

Topics

• Adult
• Contraceptive Agents, Female (administration & dosage)
• Contraceptives, Oral, Combined (administration & dosage)
• Female
• Humans
• Medroxyprogesterone Acetate (administration & dosage)
• Patient Satisfaction
• Patient Selection
• Uterine Hemorrhage (drug therapy, surgery)