DMPA & High Dose Oral Progestin (MPA) Tablets in Outpatient Treatment of Acute Excessive Vaginal Bleeding

NCT ID: NCT01148420

Last Updated: 2014-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-07-31

Brief 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.

Conditions

Dysfunctional Uterine Bleeding

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DMPA & MPA

150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days

Group Type: EXPERIMENTAL

Medroxyprogesterone 17-Acetate

Intervention Type: DRUG

Medroxyprogesterone 20mg orally 3 times a day for 3 days

medroxyprogesterone acetate

Intervention Type: DRUG

Depo Provera 150mg Intramuscular injection

Interventions

Medroxyprogesterone 17-Acetate

Medroxyprogesterone 20mg orally 3 times a day for 3 days

Intervention Type: DRUG

medroxyprogesterone acetate

Depo Provera 150mg Intramuscular injection

Intervention Type: DRUG

Other Intervention Names

Provera; Cycrin; Depo Provera Injection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Women's Health Care Clinic, Torrance, California

OTHER

Sponsor Role: lead

Responsible Party

Anita Nelson

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anita L. Nelson, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Harbor-UCLA Urgent Care

Torrance, California, United States

Countries

United States

References

Speroff L, Fritz MA. Clinical Gynecologic Endocrinology and Infertility, 7th ed. Philadelphia: Lippincott Williams & Wilkins, 2005

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 17012455 (View on PubMed)

Munro MG, New Concepts in nongestational acute uterine bleeding.Contemporary Ob-GYN;53(1):52-57

Reference Type: BACKGROUND

Other Identifiers

13530-01

Identifier Type: -

Identifier Source: org_study_id