Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis
TerminatedPhase 1NCT01028781
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis
- Conditions
- Interventions
- Drug: Thalidomide
- Sponsor
- University of North Carolina, Chapel Hill
- Collaborators
- Celgene Corporation
- Start date
- 2006-10
- Primary completion
- 2009-08
- Sex
- Female
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01028781