NCT00632697

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2008

Completed
Last Updated

March 11, 2008

Status Verified

March 1, 2008

Enrollment Period

5.2 years

First QC Date

March 4, 2008

Last Update Submit

March 10, 2008

Conditions

Endometriosis-Associated Infertility

Keywords

endometriosisimmunomodulationinfertilitylaparoscopic surgerypentoxifylline

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    6 months follow-up

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: pentoxifylline

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

pentoxifyllineDRUG

800 mg daily for six months

1
placeboDRUG
2

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Infertile patients having early endometriosis as the only factor of their infertility

You may not qualify if:

  • Previous treatment for endometriosis or patients having pelvic disorders in addition to endometriosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

  • Creus M, Fabregues F, Carmona F, del Pino M, Manau D, Balasch J. Combined laparoscopic surgery and pentoxifylline therapy for treatment of endometriosis-associated infertility: a preliminary trial. Hum Reprod. 2008 Aug;23(8):1910-6. doi: 10.1093/humrep/den167. Epub 2008 May 16.

    PMID: 18487215DERIVED

MeSH Terms

Conditions

EndometriosisInfertility

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 4, 2008

First Posted

March 11, 2008

Study Start

October 1, 2001

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

March 11, 2008

Record last verified: 2008-03

Locations

ES(1)