Profiling Vulvodynia Based on Neurobiological and Behavioral Endophenotypes

NCT02733172 | Completed

• 1 other identifier: 13-001113
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to extensively phenotype a large sample of Vulvodynia (VD) patients using functional and structural brain imaging together with genetic, physiological, and biological parameters.

Conditions

Vulvodynia

Keywords

Vulvodynia; Endophenotypes; functional MRI

Outcome Measures

Primary Outcomes (2)

• Brain morphometry measured by magnetic resonance imaging (MRI)

  Structural MRI collected to quantify these measures

  Length of the brain imaging scans is 35 minutes; assessed 1 time

• Functional connectivity measured by magnetic resonance imaging (MRI)

  Functional MRI collected to quantify these measures

  Length of the brain imaging scans is 35 minutes; assessed 1 time

Secondary Outcomes (1)

• Genotyping for candidate gene polymorphism

  5 minutes at screening for saliva sample collecteion

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women 18-55 yo with vestibulodynia, and or generalized vulvodynia, characterized by at least 3 months history of pain, burning, or irritation, with an intensity of 4/10 or greater, of the vulva localized to the vestibule (vestibulodynia) with or without pain located in outer region of the vulva (generalized VD). The pain must NOT be attributable to current bacterial, fungal, or yeast infections, a skin condition (eg; dermatitis), hormonal changes, or vaginitis.

You may qualify if:

• Sex: Female (VD is a disorder that affects women only).
• Age: 18 to 55 years of age.
• Language: Participants must be fluent in English, as demonstrated by verbal skills sufficient to participate in a conversation, including the ability to ask and answer questions at a level that assures adequate understanding of the study.
• History of VD: Participants will be required to meet criteria for VD based on history and examination: At least 3 month history of pain, burning, or irritation, with an intensity of 4/10 or greater of the vulva either localized to the vestibule and precipitated by contact of the vestibule (Provoked VD) or located in other regions of the vulva (called GVD). The pain must not be attributable to dermatitis, dermatosis, candida, hormonal changes, or vaginitis.
• Generally healthy without current neurological, cardiovascular, hepatic, renal, autoimmune diseases, diabetes or cancer.
• Willingness to use acceptable contraceptive methods (e.g., hormonal, barrier, or sterilization) if sexually active.
• Limited tobacco use allowed as described: must smoke less than 1/3 packs per day (5-6 cigarettes/day allowed) and also to be able to abstain from smoking for no less than 12 hours before MRI without any concern for nicotine craving.

You may not qualify if:

• Heavy tobacco smokers will be excluded to avoid confounding effects of nicotine withdrawal or recent smoking on assessments during functional MRI.
• Medications or treatments for VD, including psychological or physical therapy, that have been initiated less than 3 months prior to the study. Topical medication such as gabapentin or estrogens are allowed. Limited use of certain antidepressants (tricyclics and serotonin inhibitors) will be allowed.
• CNS disease: Evidence of central nervous system (CNS), cerebrovascular, and/or infectious disease, and history of neurological disease (e.g., stroke/epilepsy) or history of head trauma with loss of consciousness \>30 minutes, any history of post-traumatic amnesia, or more than one episode of head trauma, regardless of severity.
• Claustrophobia: Subjects will be questioned about their potential discomfort with enclosed spaces, such as an MRI scanner.
• Subjects reporting problems with enclosed spaces will be excluded.
• Pregnancy: subjects will be required to have a pregnancy test on the day of the MRI scan.
• Presence in the body of a metal device (e.g., pacemaker, infusion pump, aneurysm clip, metal prosthesis or plate) that could either interfere with the acquisition of the MRI scan of the brain or for whom the MRI scan would pose a potential risk will be excluded.
• Postmenopausal women defined as no menses for 12 consecutive months.
• Past medical history of other chronic pain disorders such as Irritable bowel syndrome, frequent migraines (weekly) or fibromyalgia; UNLESS vulvodynia is clearly the main pain disorder. The PI will determine if eligible.
• Oral opiates/anxiolytics and steroids are never allowed due to changes in the brain that would confound analysis.
• Morbid Obesity (BMI \> 35%)
• Current use of certain oral contraceptives, nuvaring, Intrauterine devices (IUD) or spermicide as contraceptive method.
• Use of antibiotics, antifungal or probiotics within 6 weeks of study enrollment.
• Engaging in vaginal penetration (such as sexual intercourse, douches, tampons) or use of fragranced feminine hygiene products within 7 days of study enrollment.
• Recent or active bacterial or fungal infections within 6 weeks of study enrollment.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles (UCLA)

Los Angeles, California, 90025, United States

Location

Related Publications (1)

• Oughourlian TC, Tun G, Antony KM, Gupta A, Mays VM, Mayer EA, Rapkin AJ, Labus JS. Symptom-associated alterations in functional connectivity in primary and secondary provoked vestibulodynia. Pain. 2023 Mar 1;164(3):653-665. doi: 10.1097/j.pain.0000000000002754. Epub 2022 Aug 15.

  PMID: 35972459 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

saliva samples

MeSH Terms

Conditions

Vulvodynia

Condition Hierarchy (Ancestors)

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

Study Officials

• Jennifer Labus, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: April 11, 2016
• Study Start: July 1, 2013
• Primary Completion: June 27, 2018
• Study Completion: June 30, 2018
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)