- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00632697
Pentoxifylline and Endometriosis (LETS1)
March 10, 2008 updated by: Hospital Clinic of Barcelona
Combined Laparoscopic Surgery and Pentoxifylline Therapy for Treatment of Endometriosis-Associated Infertility: A Preliminary Study
To prove efficacy of an immunomodulator called pentoxifylline in the treatment of endometriosis in infertile patients undergoing laparoscopy surgery
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Barcelona, Spain, 08036
- Hospital Clínic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Infertile patients having early endometriosis as the only factor of their infertility
Exclusion Criteria:
- Previous treatment for endometriosis or patients having pelvic disorders in addition to endometriosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: 2
|
|
ACTIVE_COMPARATOR: 1
|
800 mg daily for six months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pregnancy rate
Time Frame: 6 months follow-up
|
6 months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2001
Primary Completion (ACTUAL)
December 1, 2006
Study Completion (ACTUAL)
December 1, 2006
Study Registration Dates
First Submitted
March 4, 2008
First Submitted That Met QC Criteria
March 10, 2008
First Posted (ESTIMATE)
March 11, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
March 11, 2008
Last Update Submitted That Met QC Criteria
March 10, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LETS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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