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

This study has been terminated.
(Difficulty finding eligible participants and lack of funding.)
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01028781
First received: December 7, 2009
Last updated: December 19, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Endometriosis
Drug: Thalidomide
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • pain report [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: October 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Thalidomide
Thalidomide was administered and pain reports were recorded over the course of 6 months.
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.
Other Name: Thalomid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 years
  2. Histologically/laparoscopically confirmed endometriosis
  3. Chronic pelvic pain defined as non-menstrual pain for at least two weeks in the previous month for at least 6 months
  4. VAS of 6 or more at baseline
  5. Failure, completion or intolerance of standard treatment modalities (oral contraceptive therapy, danazol, Depo-Provera, Depo-Lupron)
  6. Patients must give written informed consent.
  7. Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program.

Exclusion Criteria:

  1. Pregnant and/or lactating female
  2. Users of other angiogenesis inhibitors
  3. Current use of Rifampin, rifabutin, barbiturates, glucocorticoids, phenytoin, carbamazepine, chlorpromazine, reserpine, penicillin derivatives, or St. Johns Wart in user of oral contraceptive therapy
  4. Use of aromatase inhibitors, Etanercept (Enbrel), GnRH agonists (Depo-Lupron), and Danazol within the past 3 months
  5. Use of norethindrone acetate (Aygestin) in the prior month
  6. Seizure disorder
  7. Hepatitis, or any active infection (upper respiratory infection, PID, etc)
  8. History of thromboembolic disease.
  9. Baseline neutropenia (ANC < 1000/mm^3)
  10. Any severe physical or metal illness that would interfere with the completion of the protocol
  11. Illicit drug or alcohol abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028781

Locations
United States, North Carolina
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Celgene Corporation
Investigators
Principal Investigator: Denniz Zolnoun, MD, MPH University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01028781     History of Changes
Other Study ID Numbers: 65681
Study First Received: December 7, 2009
Last Updated: December 19, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Endometriosis
Pelvic Pain
Genital Diseases, Female
Pain
Signs and Symptoms
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 15, 2014