Profiling Vulvodynia Based on Neurobiological and Behavioral Endophenotypes

Completed

Conditions studied: Vulvodynia

In brief

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.

Key facts

Study ID

NCT02733172

Run by

University of California, Los Angeles

People needed

168

Starts

2013-07-01

Expected to finish

2018-06-30

Last updated by the study team

2019-10-18

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

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…

• Psychiatric disease: Psychiatric criteria (DSM-IV) will be used to determine exclusion of volunteers with psychiatric illnesses. A psychological interview by a trained clinician to determine diagnoses. We will exclude participants with any disorders or psychiatric diagnoses, including, but not limited to; schizophrenia, bipolar disorder, current/active and untreated depression or generalized anxiety, post traumatic stress disorder, attention deficit hyperactive disorder, past history of eating disorders without successful treatment within 3 yrs, will not be allowed.
• History of Drug Abuse (including major nicotine dependence): We will also exclude volunteers who give self- reports or other evidence of recent (within 6 months) use of psychotropic agents (other than light marijuana or alcohol). Meeting diagnostic criteria for current abuse or dependence on alcohol or any illicit drugs of abuse will be exclusionary.
• 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.
• Menstrual cycle beginning within 1 week of study participation.

Where it is running

• University of California, Los Angeles (UCLA) — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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