Dysfunctional Uterine Bleeding Clinical Trial
Official title:
Pilot Trial of Use of DMPA Injection and High Dose MPA Tablets in Outpatient
The purpose of this study is to investigate the effectiveness and acceptability of high dose MPA (20mg oral 3 times a day) for 3 days combined with an injection of DMPA 150 mg intramuscularly in the treatment of acute heavy, prolonged uterine bleeding who have been identified as being eligible for outpatient management
Status | Completed |
Enrollment | 48 |
Est. completion date | July 2012 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Age 18- 50 - Non-pregnant - Candidate for outpatient management - Able to understand and follow instructions - Vital signs stable - No severe anemia - No medical conditions requiring transfusion Exclusion Criteria: - Pregnancy - Breast cancer current or in last 5 years - Allergy to MPA or DMPA - Previous hormonal therapies - Unstable vital signs - Bleeding excessive enough to require surgical therapy or hospital admission - Desire for pregnancy in next 6 months |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Harbor-UCLA Urgent Care | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
Women's Health Care Clinic, Torrance, California |
United States,
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. — View Citation
Munro MG, New Concepts in nongestational acute uterine bleeding.Contemporary Ob-GYN;53(1):52-57
Speroff L, Fritz MA. Clinical Gynecologic Endocrinology and Infertility, 7th ed. Philadelphia: Lippincott Williams & Wilkins, 2005
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cessation of Bleeding Within 5 Days | Patients were called within 24 hours and 48 hours following their first study visit to ascertain their bleeding status and their use of medication, as well as any significant side effects they msy have been experiencing. Patients were asked to return to the clinic on day 3 for a repeat hemoglobin and interval history. Those women who were still having any bleeding on day 3 were contacted on day 5 | 3-5 days | Yes |
Secondary | Patient Perception of the Acceptability of the Treatment | Results from a survey question that assessed the subjects' satisfaction with the therapy on a scale of 1-3. 1 = poor; 2 = good; 3 = excellent. | End of the trial; up to day 5 | No |
Secondary | Satisfaction and Willingness to Recommend Treatment | Participants were asked whether they would recommend this treatment to a friend | End of the trial; up to day 5 | No |
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