Endometriosis
Conditions
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.
Interventions
DRUGThalidomide
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
Celgene Corporation
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain report | 6 months |
Countries
United States
Outcome results
None listed