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

University of North Carolina (UNC)

Status and phase: Terminated; Phase 1

Conditions: Endometriosis

Treatments: Drug: Thalidomide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01028781

65681

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Thalidomide

Other group

Description:

Thalidomide was administered and pain reports were recorded over the course of 6 months.

Treatment:

Drug: Thalidomide