Treatment of Non-Gestational Acute Uterine Bleeding: A Randomized Trial
NCT ID: NCT00350480
Last Updated: 2015-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2003-04-30
2005-06-30
Brief Summary
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Detailed Description
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(c) Non-pregnant, hemodynamically-stable, reproductive-aged, women, over the age of IS, who present either to the emergency area or to KP practitioner's offices with acute uterine bleeding, will be considered for eligibility. If, following a full exam and medically appropriate investigations medical management is deemed appropriate, they will be approached by a member of the investigating team for possible inclusion into the study. Following informed consent, patients will be randomized to receive either medroxyprogesterone acetate (20 mg three times daily for 7 days) or monophasic oral contraceptive containing I mg of norethindrone and 35 ug of ethinyl estradiol (three dines daily for seven days). Following the seven days of therapy, those randomized to MPA will continue with 20 mg per day for three weeks while those randomized to oral contraceptives will take one pill per day for three weeks, each completing a total of four weeks of therapy. The primary outcome will be the number of days until cessation of bleeding. Other outcomes measured will include pad and tampon counts, and hemoglobin levels. Chi square tests and student t will be used to evaluate differences between the two treatment groups. The hope is that this study will elucidate on the efficacy of the two regimens.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Provera
Combination Birth Control pills
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
FEMALE
No
Sponsors
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Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Malcolm G Munro, M.D.
Role: PRINCIPAL_INVESTIGATOR
Southern California Permanente Medical Group
Romie Basu, MD
Role: PRINCIPAL_INVESTIGATOR
Southern California Permanente Medical Group
Locations
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Kaiser Permanente Sunset
Los Angeles, California, United States
Countries
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References
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Munro MG, Mainor N, Basu R, Brisinger M, Barreda L. Oral medroxyprogesterone acetate and combination oral contraceptives for acute uterine bleeding: a randomized controlled trial. Obstet Gynecol. 2006 Oct;108(4):924-9. doi: 10.1097/01.AOG.0000238343.62063.22.
Other Identifiers
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Uterine Bleeding
Identifier Type: -
Identifier Source: org_study_id
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