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Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis

NCT01028781 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2011-12-20

No results posted yet for this study

Summary

Patients will undergo a standard history and physical examination detailing objective clinical exam findings performed by one of the co-investigators. The research coordinator will obtain baseline values for intensity of pain, quality of life, and coping strategies. Baseline serum levels inflammatory markers will then be measured. Over the course of 12 weeks Thalidomide will be titrated as tolerated to achieve a minimum of a 30% reduction of pain on VAS from week 2.

Conditions

  • Endometriosis

Interventions

DRUG

Thalidomide

Pill form, 50mgs with increasing dosage up to a maximum of 250 mg qd based on pain reports, taken once daily for 14-16 weeks with one 6 month follow-up appointment.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Denniz Zolnoun, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01028781 on ClinicalTrials.gov