Pentoxifylline and Endometriosis (LETS1)

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. Identifier: NCT00632697
Recruitment Status : Completed
First Posted : March 11, 2008
Last Update Posted : March 11, 2008
Information provided by:
Hospital Clinic of Barcelona

Brief Summary:
To prove efficacy of an immunomodulator called pentoxifylline in the treatment of endometriosis in infertile patients undergoing laparoscopy surgery

Condition or disease Intervention/treatment Phase
Endometriosis-Associated Infertility Drug: pentoxifylline Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
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
Study Start Date : October 2001
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: pentoxifylline
800 mg daily for six months
Placebo Comparator: 2 Drug: placebo

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

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

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

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 identifier (NCT number): NCT00632697

Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00632697     History of Changes
Other Study ID Numbers: LETS
First Posted: March 11, 2008    Key Record Dates
Last Update Posted: March 11, 2008
Last Verified: March 2008

Keywords provided by Hospital Clinic of Barcelona:
laparoscopic surgery

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
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