DMPA & High Dose Oral Progestin (MPA) Tablets in Outpatient Treatment of Acute Excessive Vaginal Bleeding

• Sponsor: Women's Health Care Clinic, Torrance, California (Other)
• Overall Status: Completed
• CT.gov ID: NCT01148420
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arm: 1
• Duration (Months): 42
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dysfunctional Uterine Bleeding	Drug: Medroxyprogesterone 17-Acetate; Drug: medroxyprogesterone acetate	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Trial of Use of DMPA Injection and High Dose MPA Tablets in Outpatient
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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: Provera Cycrin ; Drug: medroxyprogesterone acetate; Depo Provera 150mg Intramuscular injection; Other Names: Depo Provera Injection

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harbor-UCLA Urgent Care	Torrance	California	United States	90502

Sponsors and Collaborators

• Women's Health Care Clinic, Torrance, California

Investigators

• Principal Investigator: Anita L. Nelson, M.D., University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Munro MG, New Concepts in nongestational acute uterine bleeding.Contemporary Ob-GYN;53(1):52-57
• Speroff L, Fritz MA. Clinical Gynecologic Endocrinology and Infertility, 7th ed. Philadelphia: Lippincott Williams & Wilkins, 2005

• Responsible Party: Anita Nelson, Medical Director, Women's Health Care Clinic, Torrance, California
• ClinicalTrials.gov Identifier: NCT01148420
• Other Study ID Numbers: 13530-01
• First Posted: Jun 22, 2010
• Last Update Posted: Mar 13, 2014
• Last Verified: Feb 1, 2014

• Additional relevant MeSH terms: Uterine Hemorrhage; Metrorrhagia; Hemorrhage; Medroxyprogesterone Acetate; Medroxyprogesterone

Study Results

Participant Flow

Recruitment Details	Participants were recruited from the GYN clinic at the Harbor-UCLA Medical Center.
Pre-assignment Detail	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.

Arm/Group Title	DMPA + MPA
Arm/Group Description	150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
Period Title: Overall Study
STARTED	48
COMPLETED	48
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	DMPA + MPA
Arm/Group Description
Overall Participants	48
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	48 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.7 (9.35)
Sex: Female, Male (Count of Participants)
Female	48 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	48 100%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	34.9 (8.09)
Hemoglobin baseline (g/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [g/dL]	10.9 (1.58)

Outcome Measures

1. Secondary Outcome

Title	Patient Perception of the Acceptability of the Treatment
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DMPA + MPA
Arm/Group Description	150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
Measure Participants	48
Median (Full Range) [units on a scale]	3

2. Secondary Outcome

Title	Satisfaction and Willingness to Recommend Treatment
Description	Participants were asked whether they would recommend this treatment to a friend
Time Frame	End of the trial; up to day 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DMPA + MPA
Arm/Group Description	150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
Measure Participants	48
Participants who would recommend this treatment	48 100%
Participants who would not recommend it	0 0%

3. Primary Outcome

Title	Cessation of Bleeding Within 5 Days
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DMPA + MPA
Arm/Group Description
Measure Participants	48
Number [participants]	48 100%

Adverse Events

Time Frame	Five days
Arm/Group Title	DMPA & High Dose MPA
Arm/Group Description	DMPA & High Dose MPA
All Cause Mortality
	DMPA & High Dose MPA
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	DMPA & High Dose MPA
	Affected / at Risk (%)	# Events
Total	0/48 (0%)
Other (Not Including Serious) Adverse Events
	DMPA & High Dose MPA
	Affected / at Risk (%)	# Events
Total	15/48 (31.3%)
Reproductive system and breast disorders
Bloating	7/48 (14.6%)
Fatigue	6/48 (12.5%)
Cramping	3/48 (6.3%)
Mood changes	2/48 (4.2%)
Nausea	1/48 (2.1%)
Increased appetite	1/48 (2.1%)
Bone Pain	1/48 (2.1%)

Limitations/Caveats

This was a single-arm, noncomparative pilot clinical trial. Impacts on bleeding beyond 5 days were not prospectively documented.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.