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

NCT01028781 | Terminated Phase 1 DMC

• 1 other identifier: 65681
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• pain report

  6 months

Study Arms (1)

Thalidomide

OTHER

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

Drug: Thalidomide

Interventions

Thalidomide 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.

Also known as: Thalomid

Thalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Celgene Corporation: collaborator

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Denniz Zolnoun, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: October 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 20, 2011

Record last verified: 2011-12

Locations

US (1)