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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01028781
• Other study ID #: 65681
• Status: Terminated
• Phase: Phase 1
• First received: December 7, 2009
• Last updated: December 19, 2011
• Start date: October 2006
• Est. completion date: August 2009

Study information

• Verified date: December 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis
• Pelvic Pain

Intervention

Drug:
• Thalidomide
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.

Locations

Country	Name	City	State
United States	UNC Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain report		6 months	No