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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anita Nelson, Women's Health Care Clinic, Torrance, California
ClinicalTrials.gov Identifier:
NCT01148420
First received: June 21, 2010
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Dysfunctional Uterine Bleeding
Drug: Medroxyprogesterone 17-Acetate
Drug: medroxyprogesterone acetate
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Trial of Use of DMPA Injection and High Dose MPA Tablets in Outpatient

Resource links provided by NLM:


Further study details as provided by Women's Health Care Clinic, Torrance, California:

Primary Outcome Measures:
  • Cessation of Bleeding Within 5 Days [ Time Frame: 3-5 days ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Patient Perception of the Acceptability of the Treatment [ Time Frame: End of the trial; up to day 5 ] [ Designated as safety issue: No ]
    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.

  • Satisfaction and Willingness to Recommend Treatment [ Time Frame: End of the trial; up to day 5 ] [ Designated as safety issue: No ]
    Participants were asked whether they would recommend this treatment to a friend


Enrollment: 48
Study Start Date: January 2009
Study Completion Date: July 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DMPA & MPA
150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days
Drug: Medroxyprogesterone 17-Acetate
Medroxyprogesterone 20mg orally 3 times a day for 3 days
Other Names:
  • Provera
  • Cycrin
Drug: medroxyprogesterone acetate
Depo Provera 150mg Intramuscular injection
Other Name: Depo Provera Injection

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148420

Locations
United States, California
Harbor-UCLA Urgent Care
Torrance, California, United States, 90502
Sponsors and Collaborators
Women's Health Care Clinic, Torrance, California
Investigators
Principal Investigator: Anita L. Nelson, M.D. University of California, Los Angeles
  More Information

Publications:
Responsible Party: Anita Nelson, Medical Director, Women's Health Care Clinic, Torrance, California
ClinicalTrials.gov Identifier: NCT01148420     History of Changes
Other Study ID Numbers: 13530-01
Study First Received: June 21, 2010
Results First Received: July 19, 2012
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Metrorrhagia
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Medroxyprogesterone
Medroxyprogesterone Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 22, 2014