Clinical trial NCT01148420: DMPA & High Dose Oral Progestin (MPA) Tablets in Outpatient Treatment of Acute Excessive Vaginal Bleeding
Official title: Pilot Trial of Use of DMPA Injection and High Dose MPA Tablets in Outpatient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dysfunctional Uterine Bleeding
Lead sponsor: Women's Health Care Clinic, Torrance, California
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cessation of Bleeding Within 5 Days
timeFrame: 3-5 days
Secondary outcomes:
measure: Patient Perception of the Acceptability of the Treatment
timeFrame: End of the trial; up to day 5
measure: Satisfaction and Willingness to Recommend Treatment
timeFrame: End of the trial; up to day 5
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Harbor-UCLA Urgent Care
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Anita L. Nelson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Speroff L, Fritz MA. Clinical Gynecologic Endocrinology and Infertility, 7th ed. Philadelphia: Lippincott Williams & Wilkins, 2005
citation: 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.
citation: Munro MG, New Concepts in nongestational acute uterine bleeding.Contemporary Ob-GYN;53(1):52-57