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Treatment of Non-Gestational Acute Uterine Bleeding: A Randomized Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00350480
Recruitment Status : Completed
First Posted : July 10, 2006
Last Update Posted : March 11, 2015
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
To determine the relative efficacy of multidose medroxyprogesterone acetate (MPA, Provera) and a multidose, monophasic combination oral contraceptive in the treatment of hemodynamically stable women with non-gestational, acute uterine bleeding.

Condition or disease Intervention/treatment Phase
Uterine Hemorrhage Menorrhagia Drug: Provera Drug: Combination Birth Control pills Not Applicable

Detailed Description:

Acute uterine bleeding, unrelated to pregnancy, is a relatively common problem that causes many reproductive-aged women to requite emergent medical and/or surgical intervention. Although the traditional approaches have generally been surgical in nature, many practitioners utilize medical methods to arrest the bleeding. However, despite widespread use, there exists a paucity of information regarding the effectiveness, side-effects, and patient satisfaction associated with the commonly-used medical regimens. (b) The purpose of the study is to compare the efficacy of multidose medroxyprogesterone acetate and a multidose, monophasic combined oral contraceptive in the treatment of hemodvnamically-stable women with non-gestational, acute uterine bleeding.

(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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Non-Gestational Acute Uterine BleedingComparing Oral Medroxyprogesterone Acetate and Monophasic Oral Contraceptives Containing Norethindrone and Ethinyl Estradiol
Study Start Date : April 2003
Study Completion Date : June 2005

Primary Outcome Measures :
  1. The avoidance of unscheduled surgery in the 28-day follow-up period.
  2. To calculate the time requred from initiation of medical therapy until the cessation bleeding, comparing MPA to monophasic combination oral contraceptive pills.

Secondary Outcome Measures :
  1. The assessment of pad and tampon counts.
  2. The assessment of hemoglobin levels, symptoms and side effects (ie: cramping, nausea and bloating) and patient satifaction with medical therapy.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Non-pregnant Hemodynamically stable Reproductive-aged women >18 years Present with acute uterine bleeding

Exclusion Criteria:

Pregnant Non-hemodynamically stable <18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00350480

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United States, California
Kaiser Permanente Sunset
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Kaiser Permanente
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Principal Investigator: Malcolm G Munro, M.D. Southern California Permanente Medical Group
Principal Investigator: Romie Basu, MD Southern California Permanente Medical Group
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kaiser Permanente Identifier: NCT00350480    
Other Study ID Numbers: Uterine Bleeding
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015
Keywords provided by Kaiser Permanente:
acute uterine bleeding
Additional relevant MeSH terms:
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Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Menstruation Disturbances
Medroxyprogesterone Acetate
Contraceptives, Oral
Contraceptives, Oral, Combined
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents