Endometriosis Clinical Research Study

What is the purpose of this study?

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.

Can I participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions: Endometriosis
• Age: Between 18 - 100 Years
• Gender: Female
• +

  Inclusion Criteria:

  Age > 18 years

  Histologically/laparoscopically confirmed endometriosis

  Chronic pelvic pain defined as non-menstrual pain for at least two weeks in the

  previous month for at least 6 months

  VAS of 6 or more at baseline

  Failure, completion or intolerance of standard treatment modalities (oral

  contraceptive therapy, danazol, Depo-Provera, Depo-Lupron)

  Patients must give written informed consent.

  Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.®

  program.
• +

  Exclusion Criteria:

  Pregnant and/or lactating female

  Users of other angiogenesis inhibitors

  Current use of Rifampin, rifabutin, barbiturates, glucocorticoids, phenytoin,

  carbamazepine, chlorpromazine, reserpine, penicillin derivatives, or St. Johns Wart

  in user of oral contraceptive therapy

  Use of aromatase inhibitors, Etanercept (Enbrel), GnRH agonists (Depo-Lupron), and

  Danazol within the past 3 months

  Use of norethindrone acetate (Aygestin) in the prior month

  Seizure disorder

  Hepatitis, or any active infection (upper respiratory infection, PID, etc)

  History of thromboembolic disease.

  Baseline neutropenia (ANC < 1000/mm3)

  Any severe physical or metal illness that would interfere with the completion of the

  protocol

  Illicit drug or alcohol abuse

Detail Study Description

Study Treatments

Thalidomide

Last Updated: December 2009