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CompletedNCT00814632Updated Aug 13, 2015Results posted

CC-10004 For The Treatment Of Vulvodynia

A Phase 2 interventional study of CC-10004 in Vulvodynia, sponsored by Kenneth Peters, MD. Completed at 1 site in United States. Open to female participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2015-08-13.

Sponsored by Kenneth Peters, MD · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 69 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Vulvodynia

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Keywords

  • vulvodynia
  • pelvic pain
  • vulvar pain
03

In context

Vulvodynia

106 studies on the registry are indexed under Vulvodynia; 21 are open to participants now.

This study's enrollment of 10 is below the median of 44 across 79 interventional studies indexed under Vulvodynia.

Browse Vulvodynia studies →

Lead sponsor

Kenneth Peters, MD is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Participant must understand and voluntarily sign and date the appropriate Informed Consent document.
  2. Female who is ≥ 18 years of age and \<70 years of age.
  3. Participant must be able to adhere to the study visit schedule and other protocol requirements.
  4. Participant must have vulvodynia--vulvar pain at 2 or more sites tested of at least 3 or greater on a 0-10 Likert scale.
  5. Subject -reported vulvar pain for at least 3 months prior to enrollment.
  6. Participant who is currently taking narcotics for pelvic pain must be on a stable regimen for 3 months prior to enrollment in the study.
  7. 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.
  8. 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)

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or lactating females
  2. History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic conditions, or other major diseases
  3. 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
  4. 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.
  5. Positive TB skin test (Mantoux test)
  6. 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.
  7. Clinically significant abnormality on the chest x-ray (CXR) at screening.
  8. Use of any investigational medication within 28 days prior to randomization or 5 half-lives if known (whichever is longer)
  9. Any clinically significant abnormality on 12-lead ECG at screening
  10. Positive human immunodeficiency virus (HIV), hepatitis B, or hepatitis C laboratory test result indicating active infection at screening.
  11. 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)
  12. History of a vestibulectomy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Study Drug CC 10004

    Study drug CC-10004 20mg taken orally twice a day.

    Drug: CC-10004

Interventions

  • DrugCC-10004

    CC-10004 20 mg. twice a day for 12 weeks

    Also known as: Study Drug

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

07

Results

Posted Sep 29, 2014
Limitations and caveats
Small pilot study without placebo arm. Only 7 subjects completed treatment.

Participant flow

Participant flow — Overall Study
MilestoneStudy Drug CC 10004
Started9
Completed7
Not completed2
Withdrew: Lack of efficacy2

Outcome measures

PrimaryGlobal 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.

Time frame:
12 weeks
Reported as:
Number · participants
Global Response Assessment
participantsStudy Drug CC 10004
Global Response Assessment5

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Study Drug CC 10004—0/9 (0%)0/9 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Study Drug CC 10004
<=18 years0
Between 18 and 65 years7
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Study Drug CC 10004
Female7
Male0
Region of Enrollment
Region of Enrollment(participants)Study Drug CC 10004
United States7
08

Study locations

1 site
  • William Beaumont Hospital
    Royal Oak, Michigan 48073, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00814632
Lead sponsor
Kenneth Peters, MD
Collaborators
Celgene Corporation
Responsible party
Kenneth Peters, MD (Principal Investigator, William Beaumont Hospitals) — Sponsor-investigator
First posted
Dec 25, 2008
Start date
Dec 2008
Primary completion
Feb 2011
Completion
Feb 2011
Results posted
Sep 29, 2014
Last update
Aug 13, 2015

Study contacts

Kenneth M Peters, M.D.
principal investigator · Beaumont Hospitals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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