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

Primary Purpose

Endometriosis

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • UNC Chapel Hill

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Thalidomide

Arm Description

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

Outcomes

Primary Outcome Measures

pain report

Secondary Outcome Measures

Full Information

First Posted
December 7, 2009
Last Updated
December 19, 2011
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01028781
Brief Title
Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis
Official Title
Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Terminated
Why Stopped
Difficulty finding eligible participants and lack of funding.
Study Start Date
October 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Celgene Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thalidomide
Arm Type
Other
Arm Description
Thalidomide was administered and pain reports were recorded over the course of 6 months.
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Other Intervention Name(s)
Thalomid
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain report
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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/mm^3) Any severe physical or metal illness that would interfere with the completion of the protocol Illicit drug or alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denniz Zolnoun, MD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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