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Pentoxifylline and Endometriosis (LETS1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00632697
First Posted: March 11, 2008
Last Update Posted: March 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Clinic of Barcelona
  Purpose
To prove efficacy of an immunomodulator called pentoxifylline in the treatment of endometriosis in infertile patients undergoing laparoscopy surgery

Condition Intervention Phase
Endometriosis-Associated Infertility Drug: pentoxifylline Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Combined Laparoscopic Surgery and Pentoxifylline Therapy for Treatment of Endometriosis-Associated Infertility: A Preliminary Study

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: 6 months follow-up ]

Enrollment: 104
Study Start Date: October 2001
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: pentoxifylline
800 mg daily for six months
Placebo Comparator: 2 Drug: placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632697


Locations
Spain
Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00632697     History of Changes
Other Study ID Numbers: LETS
First Submitted: March 4, 2008
First Posted: March 11, 2008
Last Update Posted: March 11, 2008
Last Verified: March 2008

Keywords provided by Hospital Clinic of Barcelona:
endometriosis
immunomodulation
infertility
laparoscopic surgery
pentoxifylline

Additional relevant MeSH terms:
Infertility
Endometriosis
Genital Diseases, Male
Genital Diseases, Female
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants