Official Title: “Two-Dose Methotrexate for Ectopic Pregnancy”

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

The regimen is an attempt to create a middle ground between the 2 commonly used regimens - "single dose" and "multi dose". The "multi dose" regimen is more effective, but the "single dose" regimen is more convenient for patients and has fewer side effects.

Intervention(s) in this Clinical Trial

• Drug: Methotrexate
  • Two dose methotrexate

Primary Measures

• Prevalence of side effects
  • Time Frame: Till quantitative bhCG values fall to zero or below 5mIU/mL
    Safety Issue?: Yes

Secondary Measures

• Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention)
  • Time Frame: Till quantitative bhCG values fall to zero or below 5mIU/mL
    Safety Issue?: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pennsylvania

Overall Clinical Trial Officials and Contacts

Kurt T Barnhart, MD, MSCE Principal Investigator University of Pennsylvania  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00194272

Study ID Number: 701460

ClinicalTrials.gov Identifier: NCT00194272

Health Authority: United States: Food and Drug Administration