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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 11, 2014

Completed
Last Updated

March 13, 2014

Status Verified

February 1, 2014

Enrollment Period

1.7 years

First QC Date

June 21, 2010

Results QC Date

July 19, 2012

Last Update Submit

February 12, 2014

Conditions

Dysfunctional Uterine Bleeding

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Patient Perception of the Acceptability of the Treatment

    End of the trial; up to day 5

  • Satisfaction and Willingness to Recommend Treatment

    End of the trial; up to day 5

Study Arms (1)

DMPA & MPA

EXPERIMENTAL

150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days

Drug: Medroxyprogesterone 17-AcetateDrug: medroxyprogesterone acetate

Interventions

Medroxyprogesterone 17-AcetateDRUG

Medroxyprogesterone 20mg orally 3 times a day for 3 days

Also known as: Provera, Cycrin
DMPA & MPA
medroxyprogesterone acetateDRUG

Depo Provera 150mg Intramuscular injection

Also known as: Depo Provera Injection
DMPA & MPA

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harbor-UCLA Urgent Care

Torrance, California, 90502, United States

Location

Related Publications (3)

  • Speroff L, Fritz MA. Clinical Gynecologic Endocrinology and Infertility, 7th ed. Philadelphia: Lippincott Williams & Wilkins, 2005

    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.

    PMID: 17012455BACKGROUND

  • Munro MG, New Concepts in nongestational acute uterine bleeding.Contemporary Ob-GYN;53(1):52-57

    BACKGROUND

MeSH Terms

Conditions

Metrorrhagia

Interventions

Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Limitations and Caveats

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

Results Point of Contact

Title
Anita Nelson
Organization
Harbor - UCLA Medical Center
anitanelsonwhc@earthlink.net
310-222-3871

Study Officials

  • Anita L. Nelson, M.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

June 21, 2010

First Posted

June 22, 2010

Study Start

January 1, 2009

Primary Completion

October 1, 2010

Study Completion

July 1, 2012

Last Updated

March 13, 2014

Results First Posted

February 11, 2014

Record last verified: 2014-02

Locations

US(1)