Ectopic PregnancyPhase 3NCT00194272
Two-Dose Methotrexate for Ectopic Pregnancy
A Phase 3 study testing Methotrexate in people with Ectopic Pregnancy, run by University of Pennsylvania at 3 sites in United States.
Trial summary
This study examines the safety and acceptability of a novel "two dose" regimen of methotrexate to treat ectopic pregnancy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- Methotrexate
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2001to Jun 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Southern California Women's and Children's Hospital
Los Angeles, California, 90033
University of Miami
Miami, Florida, 33101
University of Pennsylvania Reproductive Research Unit
Philadelphia, Pennsylvania, 19104
About this study
This study examines the safety and acceptability of a novel "two dose" regimen of methotrexate to treat ectopic pregnancy.
Read the detailed description
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.
- Conditions
- Ectopic Pregnancy
- Being tested
- Methotrexate
- Keywords
- Ectopic pregnancy, Methotrexate
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called Rheumatrex Dose Pack, Trexall
Two dose methotrexate
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of side effects
Measured: 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)
Measured: Till quantitative bhCG values fall to zero or below 5mIU/mL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMar 2001
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ectopic PregnancyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Investigators
- Kurt T Barnhart, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194272
- Sponsor's protocol ID
- 701460
- Other IDs
- RRU001
- Status last verified
- Aug 2011
- First submitted
- 13 Sep 2005
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Dose Methotrexate for Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT00194272
- Acronym / sponsor ID
- 701460
- Conditions
- Ectopic Pregnancy
- Keywords
- Ectopic pregnancy, Methotrexate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Mar 2001
- Study completion
- Jun 2007 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the safety and acceptability of a novel "two dose" regimen of methotrexate to treat ectopic pregnancy.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Confirmed diagnosis of ectopic pregnancy via
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateAlso: Rheumatrex Dose Pack, TrexallTwo dose methotrexate | Drug | – |
Primary outcome
Prevalence of side effects
Time frame: Till quantitative bhCG values fall to zero or below 5mIU/mL
1 secondary outcome
Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention)
Time frame: Till quantitative bhCG values fall to zero or below 5mIU/mL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt T Barnhart, MD, MSCE principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methotrexate in people with Ectopic Pregnancy, run by University of Pennsylvania at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of side effects (time frame: Till quantitative bhCG values fall to zero or below 5mIU/mL). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2011.