NCT00194272

Brief Summary

This study examines the safety and acceptability of a novel "two dose" regimen of methotrexate to treat ectopic pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 9, 2011

Status Verified

August 1, 2011

First QC Date

September 13, 2005

Last Update Submit

August 8, 2011

Conditions

Ectopic Pregnancy

Keywords

Ectopic pregnancyMethotrexate

Outcome Measures

Primary Outcomes (1)

  • Prevalence of side effects

    Till quantitative bhCG values fall to zero or below 5mIU/mL

Secondary Outcomes (1)

  • Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention)

    Till quantitative bhCG values fall to zero or below 5mIU/mL

Interventions

MethotrexateDRUG

Two dose methotrexate

Also known as: Rheumatrex Dose Pack, Trexall

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of ectopic pregnancy via
  • D\&E without products of conception identified on frozen pathology or
  • VABRA without products of conception identified with pathologic evaluation or
  • Ultrasound visualization of a gestational sac in the adnexa, with definitive visualization of a yolk sac or fetal pole
  • the subject is hemodynamically stable without signs of hemoperitoneum
  • laparoscopy has not been performed
  • the subject is able to return for frequent follow-up care
  • normal renal and liver function have been documented within 2 days
  • normal white blood count and platelet count have been documented as per laboratory standard
  • normal chest x-ray was obtained if the subject has a history of pulmonary disease
  • no history of allergy or sensitivity to methotrexate or any component of its formulation

You may not qualify if:

  • breastfeeding
  • laboratory evidence of immunodeficiency
  • alcoholism or chronic liver disease
  • the concomitant use of non-steroidal anti-inflammatory drugs
  • blood dyscrasia such as leukopenia, thrombocytopenia, or severe anemia
  • active pulmonary disease
  • hepatic, renal, or hematological dysfunction
  • adnexal mass \> or = 3.5 cm
  • presence of fetal cardiac motion
  • active major psychiatric disorder such as major depression, bipolar disease, psychotic disorder, or drug addiction
  • subjects unable or unwilling to comply with study procedures or illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Southern California Women's and Children's Hospital

Los Angeles, California, 90033, United States

Location

University of Miami

Miami, Florida, 33101, United States

Location

University of Pennsylvania Reproductive Research Unit

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Kurt T Barnhart, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

March 1, 2001

Study Completion

June 1, 2007

Last Updated

August 9, 2011

Record last verified: 2011-08

Locations

US(3)