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

Sponsor

Kaiser Permanente (Other)

Overall Status

Completed

CT.gov ID

NCT00350480

Collaborator

(none)

240

Enrollment

Location

Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

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 :

Apr 1, 2003

Study Completion Date :

Jun 1, 2005

Outcome Measures

Primary Outcome Measures

The avoidance of unscheduled surgery in the 28-day follow-up period. []
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

The assessment of pad and tampon counts. []
The assessment of hemoglobin levels, symptoms and side effects (ie: cramping, nausea and bloating) and patient satifaction with medical therapy. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant Non-hemodynamically stable <18 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Sunset	Los Angeles	California	United States	90027

Sponsors and Collaborators

Kaiser Permanente

Investigators

Principal Investigator: Malcolm G Munro, M.D., Southern California Permanente Medical Group
Principal Investigator: Romie Basu, MD, Southern California Permanente Medical Group