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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMPA & MPA | Experimental | 150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medroxyprogesterone 17-Acetate | Drug | Medroxyprogesterone 20mg orally 3 times a day for 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Satisfaction and Willingness to Recommend Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anita L. Nelson, M.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbor-UCLA Urgent Care | Torrance | California | 90502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Speroff L, Fritz MA. Clinical Gynecologic Endocrinology and Infertility, 7th ed. Philadelphia: Lippincott Williams & Wilkins, 2005 | ||
| 17012455 | 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. | |
| Background | Munro MG, New Concepts in nongestational acute uterine bleeding.Contemporary Ob-GYN;53(1):52-57 |
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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 were recruited from the GYN clinic at the Harbor-UCLA Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | DMPA + MPA | 150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| medroxyprogesterone acetate | Drug | Depo Provera 150mg Intramuscular injection |
|
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Participants were asked whether they would recommend this treatment to a friend |
| End of the trial; up to day 5 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DMPA + MPA |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||||
| Hemoglobin baseline | Mean | Standard Deviation | g/dL |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Full Range | units on a scale | End of the trial; up to day 5 |
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| ||||||||||||||||||||||||||
| Secondary | Satisfaction and Willingness to Recommend Treatment | Participants were asked whether they would recommend this treatment to a friend | Posted | Number | participants | End of the trial; up to day 5 |
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| |||||||||||||||||||||||||||
| 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 | Posted | Number | participants | 3-5 days |
|
|
Five days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DMPA & High Dose MPA | DMPA & High Dose MPA | 0 | 48 | 15 | 48 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloating | Reproductive system and breast disorders | Systematic Assessment | Potentially attributable to bleeding or anemia rather than to study medication. |
| |
| Fatigue | Reproductive system and breast disorders | Systematic Assessment | Potentially attributable to bleeding or anemia rather than to study medication. |
| |
| Cramping | Reproductive system and breast disorders | Systematic Assessment | Potentially attributable to bleeding or anemia rather than to study medication. |
| |
| Mood changes | Reproductive system and breast disorders | Systematic Assessment | Potentially attributable to bleeding or anemia rather than to study medication. |
| |
| Nausea | Reproductive system and breast disorders | Systematic Assessment | Potentially attributable to bleeding or anemia rather than to study medication. |
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| Increased appetite | Reproductive system and breast disorders | Systematic Assessment | Potentially attributable to bleeding or anemia rather than to study medication. |
| |
| Bone Pain | Reproductive system and breast disorders | Systematic Assessment | Potentially attributable to bleeding or anemia rather than to study medication. |
|
This was a single-arm, noncomparative pilot clinical trial. Impacts on bleeding beyond 5 days were not prospectively documented.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anita Nelson | Harbor - UCLA Medical Center | 310-222-3871 | anitanelsonwhc@earthlink.net |
| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017258 | Medroxyprogesterone Acetate |
| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Categories |
|---|
| Participants who would recommend this treatment |
| |||||
| Participants who would not recommend it |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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