Official Title: “Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis”

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.

Study Type: Interventional

Study Design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Study Primary Completion Date: January 2010

Intervention(s) in this Clinical Trial

• Drug: Thalidomide
  • Pill form, 50mgs with increasing dosage based on pain reports, taken once daily for 14-16 weeks with one 6 month follow-up appointment.

Arms, Groups and Cohorts in this Clinical Trial

• Other: Thalidomide
  • Thalidomide will be administered and pain report will be recorded over the course of 6 months.

Primary Measures

• pain report
  • Time Frame: 6 months
    Safety Issue?: 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/mm3)
• 10. Any severe physical or metal illness that would interfere with the completion of the protocol
• 11. Illicit drug or alcohol abuse

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of North Carolina, Chapel Hill

Overall Clinical Trial Officials and Contacts

Overall Contact: Denniz Zolnoun, MD, MPH 919 966 9189 zolnound@med.unc.edu

Information obtained from ClinicalTrials.gov on September 01, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01028781

Study ID Number: 65681

ClinicalTrials.gov Identifier: NCT01028781

Health Authority: United States: Food and Drug Administration