| September 13, 2005 |
| February 12, 2009 |
| March 2001 |
| |
| Prevalence of side effects [ Time Frame: Till quantitative bhCG values fall to zero or below 5mIU/mL ] [ Designated as safety issue: Yes ] |
| Prevalence of side effects |
| Complete list of historical versions of study NCT00194272 on ClinicalTrials.gov Archive Site |
| Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention) [ Time Frame: Till quantitative bhCG values fall to zero or below 5mIU/mL ] [ Designated as safety issue: No ] |
| Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention) |
| |
| Two-Dose Methotrexate for Ectopic Pregnancy |
| 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. |
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. |
| Phase III |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Ectopic Pregnancy |
| Drug: Methotrexate |
| |
| |
| |
| Completed |
| 100 |
| June 2007 |
|
Inclusion Criteria:
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
|
| Female |
|
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00194272 |
| Kurt T Barnhart, MD, MSCE, University of Pennsylvania |
| 701460, RRU001 |
| University of Pennsylvania |
| Bill and Melinda Gates Foundation |
| Principal Investigator: |
Kurt T Barnhart, MD, MSCE |
University of Pennsylvania |
|
|
| University of Pennsylvania |
| February 2009 |