To prove efficacy of an immunomodulator called pentoxifylline in the treatment of endometriosis in infertile patients undergoing laparoscopy...
Date First Received: March 4, 2008
Last Updated: March 10, 2008
Verified by: Hospital Clinic of Barcelona, March 2008
Clinical Trial Phase: Phase 3 | Start Date: October 2001
Overall Status: Completed
Estimated Enrollment: 104
Brief Summary
Official Title: “Combined Laparoscopic Surgery and Pentoxifylline Therapy for Treatment of Endometriosis-Associated Infertility: A Preliminary Study”
Condition Keyword(s):
Intervention(s):
To prove efficacy of an immunomodulator called pentoxifylline in the treatment of endometriosis in infertile patients undergoing laparoscopy surgery
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Study Primary Completion Date: December 2006
Intervention(s) in this Clinical Trial
- Drug: pentoxifylline
- 800 mg daily for six months
- Drug: placebo
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Placebo Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Pregnancy rate
- Time Frame: 6 months follow-up
Safety Issue?: No
- Time Frame: 6 months follow-up
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 40 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Hospital Clinic of Barcelona
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00632697
Study ID Number: LETS
ClinicalTrials.gov Identifier: NCT00632697
Health Authority: Spain: Comité Ético de Investigación Clínica
Clinical Trials Authorship and Review
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