A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response

NCT01301001 | Completed Results DMC

• 1 other identifier: 10-00985-FB CSBrown Vulvodynia
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Vulvodynia

Keywords

Vulvodynia

Outcome Measures

Primary Outcomes (1)

• Tampon Test Pain Intensity

  Tampon pain on a 11-point Numeric Rating Scale (0 = no pain at all; 10 = worse pain ever). One tampon was inserted each week. Tampon pain was assessed during last week of maintenance phase (7 days).

  Week 6 for each treatment arm

Secondary Outcomes (2)

• Coital Pain

  Week 6 of each treatment arm

• Vulvodynia Pain

  Week 6 for each treatment arm

Study Arms (2)

Placebo oral capsule

PLACEBO COMPARATOR

Placebo capsule daily in first intervention period and Gabapentin capsule 3000 mg daily in in second intervention (after washout period)

Drug: Placebo oral capsule; Drug: Gabapentin

Gabapentin

ACTIVE COMPARATOR

Gabapentin capsule 3000 mg daily in first intervention period and Placebo capsule in second intervention (after washout period)

Drug: Placebo oral capsule; Drug: Gabapentin

Interventions

Placebo oral capsule DRUG

Placebo 2 capsules am and 3 capsules pm

Also known as: Sugar pill

Gabapentin; Placebo oral capsule

Gabapentin DRUG

Gabapentin 1200 mg am and 1800 mg pm

Also known as: Gralise 600 mg capsule

Gabapentin; Placebo oral capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• Greater than 3 continuous months of insertional (entryway) dyspareunia, pain to touch, or both with tampon insertion (modified 'Friedrich's Criteria', and
• 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

You may not qualify if:

• Other vulvar conditions, including dermatoses, vulvitis, vulvar papillomatosis, or atrophic vaginitis (presence of a maturation index)
• previous vestibulotomy
• active vaginal infection (positive Affirm ™ VPIII microbial identification test)
• pregnancy or at risk for pregnancy and not using a reliable birth control method for at least 3 months prior to entering the study
• 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
• 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
• multiple allergies
• 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
• 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)
• topical lidocaine use
• 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
• Subject who have previously taken gabapentin or Lyrica but discontinued the medication due to side effects are not eligible
• Subjects with active infections (Candida, BV, trichomonas, chlamydia, GC and HSV via Affirm/culture) must be treated and re-screened to eligible for participation
• 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
• Subjects who have had gastric bypass surgery are ineligible for study participation due to drug absorption problems

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (3)

Rutgers - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901-1962, United States

Location

University of Rochester School of Medicine and Dentistry

Rochester, New York, 14642-0002, United States

Location

Clinical Research Center

Memphis, Tennessee, 38104, United States

Location

Related Publications (1)

• Brown CS, Bachmann GA, Wan J, Foster DC; Gabapentin (GABA) Study Group. Gabapentin for the Treatment of Vulvodynia: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jun;131(6):1000-1007. doi: 10.1097/AOG.0000000000002617.

  PMID: 29742655 DERIVED

MeSH Terms

Conditions

Vulvodynia

Interventions

Sugars; Gabapentin

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Candace Brown
• Organization: University of Tennessee Health Science Center

CSBROWN@TENNESSEE.EDU

9014124341

Study Officials

• Candace S Brown, MSN, PharmD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

• David C Foster, M.D.

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Gloria A Bachmann, M.D.

  Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: February 23, 2011
• Study Start: August 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: November 8, 2017
• Results First Posted: November 8, 2017

Record last verified: 2016-04

Locations

US (3)