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

Stopped early · Phase 1

Conditions studied: Endometriosis

In brief

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.

Key facts

Study ID

NCT01028781

Run by

University of North Carolina, Chapel Hill

People needed

9

Starts

2006-10-01

Expected to finish

2009-08-01

Last updated by the study team

2011-12-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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/mm\^3)
• Any severe physical or metal illness that would interfere with the completion of the protocol
• Illicit drug or alcohol abuse

Where it is running

• UNC Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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