DMPA & High Dose Oral Progestin (MPA) Tablets in Outpatient Treatment of Acute Excessive Vaginal Bleeding
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|ClinicalTrials.gov Identifier: NCT01148420|
Recruitment Status : Completed
First Posted : June 22, 2010
Results First Posted : February 11, 2014
Last Update Posted : March 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Dysfunctional Uterine Bleeding||Drug: Medroxyprogesterone 17-Acetate Drug: medroxyprogesterone acetate||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Trial of Use of DMPA Injection and High Dose MPA Tablets in Outpatient|
|Study Start Date :||January 2009|
|Primary Completion Date :||October 2010|
|Study Completion Date :||July 2012|
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:Drug: medroxyprogesterone acetate
Depo Provera 150mg Intramuscular injection
Other Name: Depo Provera Injection
- Cessation of Bleeding Within 5 Days [ Time Frame: 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
- Patient Perception of the Acceptability of the Treatment [ Time Frame: 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 [ Time Frame: End of the trial; up to day 5 ]Participants were asked whether they would recommend this treatment to a friend
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148420
|United States, California|
|Harbor-UCLA Urgent Care|
|Torrance, California, United States, 90502|
|Principal Investigator:||Anita L. Nelson, M.D.||University of California, Los Angeles|