VulvodyniaPhase 2NCT00814632
CC-10004 For The Treatment Of Vulvodynia
A Phase 2 study testing CC-10004 in people with Vulvodynia, run by Kenneth Peters, MD at 1 site in United States.
Trial summary
Vulvodynia is characterized by persistent vulvar pain, which often occurs upon touch or pressure. The cause of vulvodynia is unknown but is presumed to involve many factors. Some of these factors may include altered immune response, infections, altered vaginal acid-base balance, allergic reactions and psychosexual… Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Vulvodynia
- What is being tested?
- CC-10004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Feb 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must understand and voluntarily sign and date the appropriate Informed Consent document.
- Female who is ≥ 18 years of age and <70 years of age.
- Participant must be able to adhere to the study visit schedule and other protocol requirements.
- Participant must have vulvodynia--vulvar pain at 2 or more sites tested of at least 3 or greater on a 0-10 Likert scale.
- Subject -reported vulvar pain for at least 3 months prior to enrollment.
- Participant who is currently taking narcotics for pelvic pain must be on a stable regimen for 3 months prior to enrollment in the study.
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- Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening/baseline (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception while on study medication: oral, injectable, or implantable hormonal contraceptives; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner. A FCBP must agree to have pregnancy tests every 28 days while on study medication.
- Subject must meet the following laboratory criteria:
- Hemoglobin > 9 g/dL
- Hematocrit ≥ 27%
- White blood cell (WBC) count ≥ 3000 /mL (≥ 3.0 X 109/L) and < 20,000/mL (< 20 X 109/L)
- Neutrophils ≥ 1500 /mL (≥ 1.5 X 109/L)
- Platelets ≥ 100,000 /mL (≥ 100 X 109/L)
- Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
- Total bilirubin £ 2.0 mg/dL
- Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) < 1.5x upper limit of normal (ULN)
Who cannot join
- Pregnant or lactating females
- History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic conditions, or other major diseases
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- History of active Mycobacterium tuberculosis infection (any subspecies) within 3 years prior to the screening visit. Infections that occurred > 3 years prior to entry must have been effectively treated.
- Positive TB skin test (Mantoux test)
- History of incompletely treated latent Mycobacterium tuberculosis infection as indicated by a positive positive Purified Protein Derivative [PPD] skin test or in vitro test [T-SPOT®. TB, QuantiFERON Gold®] or chest x-ray.
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- Clinically significant abnormality on the chest x-ray (CXR) at screening.
- Use of any investigational medication within 28 days prior to randomization or 5 half-lives if known (whichever is longer)
- Any clinically significant abnormality on 12-lead ECG at screening
- Positive human immunodeficiency virus (HIV), hepatitis B, or hepatitis C laboratory test result indicating active infection at screening.
- History of malignancy within previous 5 years (except for treated basal-cell skin carcinoma(s) and/or fewer than 3 treated squamous-cell skin carcinomas)
- History of a vestibulectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: A Clinical Trial Of CC-10004 For The Treatment Of Vulvodynia
Vulvodynia is characterized by persistent vulvar pain, which often occurs upon touch or pressure. The cause of vulvodynia is unknown but is presumed to involve many factors. Some of these factors may include altered immune response, infections, altered vaginal acid-base balance, allergic reactions and psychosexual disorders. Women are generally treated with medications such as anti-histamines, anti-depressants and anti-inflammatories, or with physical therapy to minimize symptoms. Other therapies for vulvodynia include topical agents (lidocaine, or compounded medications such as baclofen, gabapentin and amitriptyline), oral medications (gabapentin, pregabalin, calcium citrate), complementary therapies (yoga, guided imagery, cognitive behavioral therapy) or a low-oxalate diet, but these are often ineffective. Surgery for vulvodynia may be helpful in the hard to manage cases, but is utilized as a last resort.
Read the detailed description
CC-10004 is a well-tolerated, selective PDE4 inhibitor with a demonstrated inhibitory effect on inflammatory mediators and is under development for the treatment of inflammatory and immune mediated conditions.
This is an open-label, one arm, phase II study at William Beaumont Hospital. Twenty female subjects aged 18 or older meeting criteria for diagnosis of vulvodynia or vulvar vestibulitis (vestibulodynia) will be treated with CC-10004 at 20mg orally twice a day for 12 weeks.The patient will be seen for a total of ten visits by the study coordinator.
- Conditions
- Vulvodynia
- Being tested
- CC-10004
- Keywords
- vulvodynia, pelvic pain, vulvar pain
- Medical subject headings
- Vulvodynia, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-10004Drug
Also called Study Drug
CC-10004 20 mg. twice a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Study Drug CC 10004 | Experimental | Study drug CC-10004 20mg taken orally twice a day. Receives: Drug: CC-10004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Response Assessment
The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms. The GRA is a 7-point scale the allows the subject to respond to the question: "As compared to when you started the study, overall how do you feel? The responses are: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1.
The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth Peters, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor-investigator, Kenneth Peters, MD, Corewell Health East
- Investigators
- Kenneth M Peters, M.D., Principal investigator, Beaumont Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814632
- Sponsor's protocol ID
- 2007-134
- Status last verified
- Aug 2015
- First submitted
- 23 Dec 2008
- Last updated
- 13 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Of CC-10004 For The Treatment Of Vulvodynia
- ClinicalTrials.gov ID
- NCT00814632
- Acronym / sponsor ID
- 2007-134
- Conditions
- Vulvodynia
- Keywords
- vulvodynia, pelvic pain, vulvar pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kenneth Peters, MDUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Dec 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 25 Dec 2008 (estimated)
- Results
- Posted 29 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vulvodynia is characterized by persistent vulvar pain, which often occurs upon touch or pressure. The cause of vulvodynia is unknown but is presumed to involve many factors. Some of these factors may include altered immune response, infections, altered vaginal acid-base balance, allergic reactions and psychosexual disorders. Women are generally treated with medications such as anti-histamines, anti-depressants and anti-inflammatories, or with physical therapy to minimize symptoms. Other therapies for vulvodynia include topical agents (lidocaine, or compounded medications such as baclofen, gabapentin and amitriptyline), oral medications (gabapentin, pregabalin, calcium citrate), complementary therapies (yoga, guided imagery, cognitive behavioral therapy) or a low-oxalate diet, but these are often ineffective. Surgery for vulvodynia may be helpful in the hard to manage cases, but is utilized as a last resort.
Detailed description
CC-10004 is a well-tolerated, selective PDE4 inhibitor with a demonstrated inhibitory effect on inflammatory mediators and is under development for the treatment of inflammatory and immune mediated conditions.
This is an open-label, one arm, phase II study at William Beaumont Hospital. Twenty female subjects aged 18 or older meeting criteria for diagnosis of vulvodynia or vulvar vestibulitis (vestibulodynia) will be treated with CC-10004 at 20mg orally twice a day for 12 weeks.The patient will be seen for a total of ten visits by the study coordinator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Drug CC 10004 | Experimental | Drug: CC-10004Study drug CC-10004 20mg taken orally twice a day. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participant must understand and voluntarily sign and date the appropriate Informed Consent document.
- Female who is ≥ 18 years of age and <70 years of age.
- Participant must be able to adhere to the study visit schedule and other protocol requirements.
- Participant must have vulvodynia--vulvar pain at 2 or more sites tested of at least 3 or greater on a 0-10 Likert scale.
- Subject -reported vulvar pain for at least 3 months prior to enrollment.
Key exclusion criteria (12 listed)
- Pregnant or lactating females
- History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic conditions, or other major diseases
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- History of active Mycobacterium tuberculosis infection (any subspecies) within 3 years prior to the screening visit. Infections that occurred > 3 years prior to entry must have been effectively treated.
- Positive TB skin test (Mantoux test)
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 |
|---|---|---|
| CC-10004Also: Study DrugCC-10004 20 mg. twice a day for 12 weeks | Drug | Study Drug CC 10004 |
Primary outcome
Global Response Assessment
Time frame: 12 weeks
The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms. The GRA is a 7-point scale the allows the subject to respond to the question: "As compared to when you started the study, overall how do you feel? The responses are: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1. The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Vulvodynia
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
Vulvodynia
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Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Active, not recruiting
Vestibulectomy Surgical Techniques Comparison Study
Vulvar Pain, Vulvodynia
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Not yet recruitingPhase 2
A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia
Vulvodynia
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.
Kenneth M Peters, M.D. principal investigator
Beaumont Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CC-10004 in people with Vulvodynia, run by Kenneth Peters, MD 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 16 inclusion and 12 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: finished, as of the sponsor's last update on 13 Aug 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Global Response Assessment (time frame: 12 weeks). 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 13 Aug 2015.