DMPA & High Dose Oral Progestin (MPA) Tablets in Outpatient Treatment of Acute Excessive Vaginal Bleeding
Condition: Dysfunctional Uterine Bleeding
MeSH terms: Uterine Hemorrhage; Metrorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      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
    

Detailed description: 
      Excessive vaginal bleeding is a frequent problem for reproductive age women and accounts for
      many office and emergency room visits. This bleeding is caused by cancer, endocrinologic
      problems, liver failure, benign tumors of the uterus, and cervix, as well as hormone
      imbalances, such as anovulatory cycling.

      Even though excessive vaginal bleeding is very common, there has been very little research
      into ways to manage it. For non-pregnant women who have stable vital signs and are not
      hemorrhaging or experiencing severe anemia, outpatient therapy is generally attempted.
      Textbooks recommend treatment with high dose oral contraceptives pills (one tablet orally 2
      times a day for 5 days). Recently, Munro et al published a small study using high doses of
      oral progestin (MPA 20mg 3 times daily for 7 days then one daily for 21 days). The median
      time to bleeding cessation was 3 days. Munro reported having difficulty enrolling adequate
      numbers of patients to achieve the statistical significance.

      The investigators propose a pilot project to study clinical responses to a new hormonal
      therapy the blends the high dose oral therapy with the longer acting injectable progestin.
      The pilot clinical trial is designed to study 50 women who are bleeding and whose treatment
      is amenable to outpatient therapy. Routine care will be provided to each of the women before
      she is approached for study enrollment.

      This study, therefore, is designed to provide short term proven therapy of 20 mg MPA tablets
      3 times a day for 3 days combined with the injectable progestin (DMPA) that lasts for 3
      months.

      Patients will be 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 may be experiencing. Patients will be asked to return to the clinic on day 3 for
      a repeat hemoglobin and interval history. Those women who are still having any bleeding on
      day 3 will be contacted on day 5.

      The primary outcome measures of the part of the study will be the time elapsed to slowing
      acute bleeding as well as compliance with study medications. The patient's time to complete
      cessation of bleeding and percent of women having complete bleeding cessation will also be
      calculated. Results of the biopsies done before randomization will also be evaluated to see
      if they had any influence on study outcomes. From the degree of responses seen in this pilot
      study, a larger clinical trial may be designed.
    

Intervention name(s): Medroxyprogesterone 17-Acetate; medroxyprogesterone acetate
Intervention type(s): Drug; Drug
Intervention description(s): Medroxyprogesterone 20mg orally 3 times a day for 3 days; Depo Provera 150mg Intramuscular injection
Other intervention name(s): Provera; Cycrin; Depo Provera Injection
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment