Vulvodynia | A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response
Vulvodynia research study
What is the primary objective of this study?
The Specific aims of this project are to (1) test the prediction that pain from tampon insertion (primary outcome measure) is lower in PVD patients when treated with gabapentin compared to when treated with placebo. Secondary outcome measures include intercourse pain and 24-hour pain and (2)perform a mechanism-based analysis of gabapentin effectiveness, and to gain insight into the underlying pathophysiology of subtypes of PVD that may lead to more specific treatment options.
Who is eligible to participate?
Inclusion Criteria: 1. Women who are 18 years of age and older, as long as no vaginal atrophy is present. If vaginal atrophy is present, then topical hormone replacement can be provided for a minimum of 6 weeks and then she must be re-screened to be eligible, 2. Greater than 3 continuous months of insertional (entryway) dyspareunia, pain to touch, or both with tampon insertion (modified 'Friedrich's Criteria', and 3. an average pain level of \"4\" or greater on the 11-point tampon test (0 = no pain at all; 10 = worse pain ever) during the 2-week screening period must be exhibited. (One tampon will be inserted each week). 4.) Must report pain with the \"Tampon Insertion Pain\" Test at visit 1 Exclusion Criteria: 1. Other vulvar conditions, including dermatoses, vulvitis, vulvar papillomatosis, or atrophic vaginitis (presence of a maturation index) 2. previous vestibulotomy 3. active vaginal infection (positive Affirm ™ VPIII microbial identification test) 4. pregnancy or at risk for pregnancy and not using a reliable birth control method for at least 3 months prior to entering the study 5. any unstable medical condition, including renal impairment (creatinine clearance of ≤60 mL/min, BUN > 30mg/dL, serum creatinine > 2 mg/dL), significant hematological disease (leukopenia [WBC < 3.0 x 10-3µl, leukocytosis [WBC >20.0 x 10-3μl], neutropenia [ABS < 1.50 x 10-3 μl, <20%]), (thrombocytopenia [platelets < 100,000 μl], anemia [HCT < 27%, HBG <8 g/dL, RBC <3 x 10-6]), cardiovascular disease (cardiac conduction disturbance, CHF, hypertension [140/90]), hepatic insufficiency (serum AST, ALT, or ALP ≥ 3 times upper limit of normal), neurological disorder (seizures, syncopal episodes, peripheral neuropathy, severe pain other than that caused by vulvodynia), autoimmune disease, or respiratory illness 6. psychiatric disorder, including history of major depressive disorder or substance abuse disorder within the past 6 months, a score of > 12 on the depression subscale of the Hospital Anxiety and Depression Scale (HADS), indicting a major depressive episode (35,36), a serious risk of suicide, or lifetime history of psychosis, hypomania or mania 7. multiple allergies 8. use of benzodiazepines, opiates, muscle relaxants, tricyclic antidepressants (TCAs), serotonin-norepinephrine reuptake inhibitors (SNRIs) or CNS stimulants (including methylphenidate, amphetamine dextroamphetamine) within 2 weeks of randomization and during the study 9. use of certain herbal agents within 2 weeks of randomization and during the study, including ginkgo biloba, evening primrose, St. John's Wort, Valerian, kava kava) 10. topical lidocaine use 11. Subjects, who are diagnosed with coexisting vaginismus, fibromyalgia and/or interstitial cystitis, must have greater vulvar pain than their coexisting conditions or they will not be eligible for study participation 12. Subject who have previously taken gabapentin or Lyrica but discontinued the medication due to side effects are not eligible 13. Subjects with active infections (Candida, BV, trichomonas, chlamydia, GC and HSV via Affirm/culture) must be treated and re-screened to eligible for participation 14. Subjects with 10% or greater parabasal cells and/or vaginal atrophy can be provided with topical hormone replacement for a minimum of 6 weeks and then must be re-screened to be eligible 15. Subjects who have had gastric bypass surgery are ineligible for study participation due to drug absorption problems 16. HPV/abnormal Pap is not exclusionary 17. Ongoing counseling and/or physical therapy is not exclusionary 18. Subjects who report signs of mixed Vulvodynia (spontaneous/provoked, localized, generalized) during prescreening will not be excluded
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Placebo oral capsulePlacebo 2 capsules am and 3 capsules pm
Drug:GabapentinGabapentin 1200 mg am and 1800 mg pm
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Placebo oral capsulePlacebo capsule daily in first intervention period and Gabapentin capsule 3000 mg daily in in second intervention (after washout period)
GabapentinGabapentin capsule 3000 mg daily in first intervention period and Placebo capsule in second intervention (after washout period)
Start Date: August 2012
Completed Date: January 2016
Primary Outcome: The primary outcome measure of this project are to test the prediction that pain from tampon insertion is lower in PVD patients when treated with gabapentin compared to when treated with placebo.
Secondary Outcome: The secondary outcome measure is to perform a mechanism-based analysis of gabapentin effectiveness, and to gain insight into the underlying pathophysiology of subtypes of PVD that may lead to more specific treatment options.
Study sponsors, principal investigator, and references
Principal Investigator: Candace S Brown, MSN, PharmD
Lead Sponsor: University of Tennessee
Collaborator: University of Tennessee Health Science Center