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

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic

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
Drug: placebo
ACTIVE_COMPARATOR: 1
Drug: pentoxifylline
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

Hospital Clinic of Barcelona

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.

General Publications

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

Keywords

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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