Trial of Use of Injectable Progestin (DMPA) Injection and High Dose Oral Progestin (MPA) Tablets in Outpatient Treatment of Acute Excessive Vaginal Bleeding.
Recruitment status was Recruiting
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 (such as thyroid dysfunction), liver failure, benign tumors of the uterus (fibroids), and cervix (polyps), 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, Munroe 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). Using this, 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.
Dysfunctional Uterine Bleeding
Drug: Medroxyprogesterone 17-Acetate
Drug: medroxyprogesterone acetate
|Study Design:||Allocation: Non-Randomized
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|
- Slowing of acute bleeding. [ Time Frame: 24-28 hours ] [ Designated as safety issue: Yes ]
- Complete cessation of bleeding [ Time Frame: 24-120hours ] [ Designated as safety issue: Yes ]
- Compliance with study medication. [ Time Frame: 24-72 hours ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||October 2010|
|Estimated Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Drug: Medroxyprogesterone 17-Acetate
|Contact: Anita L Nelson, MDemail@example.com|
|United States, California|
|Harbor-UCLA Urgent Care||Recruiting|
|Torrance, California, United States, 90502|
|Contact: Anita L. Nelson, M.D. 310-222-8110 firstname.lastname@example.org|
|Principal Investigator: Anita L. Nelson, M.D.|
|Principal Investigator:||Anita L. Nelson, M.D.||University of California, Los Angeles|