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

Dysfunctional Uterine Bleeding Clinical Trial

Official title:

Pilot Trial of Use of DMPA Injection and High Dose MPA Tablets in Outpatient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148420
• Other study ID #: 13530-01
• Status: Completed
• Phase: Phase 4
• First received: June 21, 2010
• Last updated: February 12, 2014
• Start date: January 2009
• Est. completion date: July 2012

Study information

• Verified date: February 2014
• Source: Women's Health Care Clinic, Torrance, California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysfunctional Uterine Bleeding
• Metrorrhagia
• Uterine Hemorrhage

Intervention

Drug:
• Medroxyprogesterone 17-Acetate
Medroxyprogesterone 20mg orally 3 times a day for 3 days
• medroxyprogesterone acetate
Depo Provera 150mg Intramuscular injection

Locations

Country	Name	City	State
United States	Harbor-UCLA Urgent Care	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Women's Health Care Clinic, Torrance, California

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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