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

NCT ID: NCT01028781

Last Updated: 2011-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thalidomide

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

Group Type OTHER

Thalidomide

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Thalomid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Celgene Corporation

INDUSTRY

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denniz Zolnoun, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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UNC Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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65681

Identifier Type: -

Identifier Source: org_study_id