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

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: NCT01028781
Recruitment Status : Terminated (Difficulty finding eligible participants and lack of funding.)
First Posted : December 9, 2009
Last Update Posted : December 20, 2011
Celgene Corporation
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Thalidomide Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis
Study Start Date : October 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Thalidomide
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. pain report [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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): NCT01028781

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
Principal Investigator: Denniz Zolnoun, MD, MPH University of North Carolina, Chapel Hill

Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT01028781     History of Changes
Other Study ID Numbers: 65681
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: December 20, 2011
Last Verified: December 2011

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