EndometriosisPhase 1NCT01028781
Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis
A Phase 1 study testing Thalidomide in people with Endometriosis, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Thalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Aug 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Thalidomide
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Also called Thalomid
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.
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide | Other | Thalidomide was administered and pain reports were recorded over the course of 6 months. Receives: Drug: Thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain report
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startOct 2006
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Difficulty finding eligible participants and lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Denniz Zolnoun, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028781
- Sponsor's protocol ID
- 65681
- Status last verified
- Dec 2011
- First submitted
- 7 Dec 2009
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis
- ClinicalTrials.gov ID
- NCT01028781
- Acronym / sponsor ID
- 65681
- Conditions
- Endometriosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty finding eligible participants and lack of funding.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Oct 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thalidomide | Other | Drug: ThalidomideThalidomide was administered and pain reports were recorded over the course of 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThalidomideAlso: ThalomidPill 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. | Drug | Thalidomide |
Primary outcome
pain report
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Difficulty finding eligible participants and lack of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denniz Zolnoun, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thalidomide in people with Endometriosis, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty finding eligible participants and lack of funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain report (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2011.