Dysfunctional Uterine Bleeding
Conditions
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.
Interventions
Medroxyprogesterone 20mg orally 3 times a day for 3 days
DRUGmedroxyprogesterone acetate
Depo Provera 150mg Intramuscular injection
Sponsors
Women's Health Care Clinic, Torrance, California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cessation of Bleeding Within 5 Days | 3-5 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Perception of the Acceptability of the Treatment | End of the trial; up to day 5 | 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 | End of the trial; up to day 5 | Participants were asked whether they would recommend this treatment to a friend |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the GYN clinic at the Harbor-UCLA Medical Center.
Pre-assignment details
Women were excluded if they were pregnant, hemodynamically unstable, had a known endometrial or cervical carcinoma, required immediate surgery, had hemoglobin less than 8, or had failed an earlier hormonal treatment for the current episode of bleeding.
Participants by arm
| Arm | Count |
|---|---|
| DMPA + MPA | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | DMPA + MPA |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants |
| Age, Continuous | 40.7 years STANDARD_DEVIATION 9.35 |
| BMI | 34.9 kg/m^2 STANDARD_DEVIATION 8.09 |
| Hemoglobin baseline | 10.9 g/dL STANDARD_DEVIATION 1.58 |
| Region of Enrollment United States | 48 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
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
Time frame: 3-5 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DMPA + MPA | Cessation of Bleeding Within 5 Days | 48 participants |
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.
Time frame: End of the trial; up to day 5
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DMPA + MPA | Patient Perception of the Acceptability of the Treatment | 3 units on a scale |
Secondary
Satisfaction and Willingness to Recommend Treatment
Participants were asked whether they would recommend this treatment to a friend
Time frame: End of the trial; up to day 5
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DMPA + MPA | Satisfaction and Willingness to Recommend Treatment | Participants who would recommend this treatment | 48 participants |
| DMPA + MPA | Satisfaction and Willingness to Recommend Treatment | Participants who would not recommend it | 0 participants |