NCT00350480

Brief Summary

To determine the relative efficacy of multidose medroxyprogesterone acetate (MPA, Provera) and a multidose, monophasic combination oral contraceptive in the treatment of hemodynamically stable women with non-gestational, acute uterine bleeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2003

Typical duration for not_applicable

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

April 1, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

First QC Date

July 6, 2006

Last Update Submit

March 10, 2015

Conditions

Uterine HemorrhageMenorrhagia

Keywords

acute uterine bleeding

Outcome Measures

Primary Outcomes (2)

  • The avoidance of unscheduled surgery in the 28-day follow-up period.

  • To calculate the time requred from initiation of medical therapy until the cessation bleeding, comparing MPA to monophasic combination oral contraceptive pills.

Secondary Outcomes (2)

  • The assessment of pad and tampon counts.

  • The assessment of hemoglobin levels, symptoms and side effects (ie: cramping, nausea and bloating) and patient satifaction with medical therapy.

Interventions

ProveraDRUG
Combination Birth Control pillsDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-pregnant Hemodynamically stable Reproductive-aged women \>18 years Present with acute uterine bleeding

You may not qualify if:

  • Pregnant Non-hemodynamically stable \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Sunset

Los Angeles, California, 90027, United States

Location

Related Publications (1)

  • 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: 17012455DERIVED

MeSH Terms

Conditions

Uterine HemorrhageMenorrhagia

Interventions

Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Intervention Hierarchy (Ancestors)

MedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Malcolm G Munro, M.D.

    Southern California Permanente Medical Group

    PRINCIPAL INVESTIGATOR

  • Romie Basu, MD

    Southern California Permanente Medical Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 10, 2006

Study Start

April 1, 2003

Study Completion

June 1, 2005

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations

US(1)