Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT01148420
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.
Study:
NCT01148420
Study Brief:
Protocol Section:
NCT01148420