Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02733172
Other study ID # 13-001113
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2013
Est. completion date June 30, 2018

Study information

Verified date October 2019
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Vulvodynia (VD) is a chronic pain disorder affecting up to 15% of women and resulting in substantial impairment in health-related quality-of-life. The treatment of the disorder is hampered by a lack of knowledge regarding its neurobiological basis. The proposed study is based on the general hypothesis that like other persistent pain conditions, VD clinical phenotypes (characteristic of the disorder) are composed of multiple biological endophenotypes (such as an hereditary characteristic that is normally associated with a condition but not a direct symptom of that condition) and that meaningful subgroups can be identified.

In the current proposal, the investigators plan to extensively phenotype a large sample of VD patients using functional and structural brain imaging together with genetic, physiological, and biological parameters. The hypothesis is that central mechanisms (including alterations in the processing/modulation of interoceptive signals from the external genitals) are important determinants of the clinical presentation, and that differences in these brain signatures could play an important role in treatment responsiveness. Such phenotyping has considerable implications for future drug development.

There will be a total of 100 females diagnosed with either generalized vulvodynia (GVD) or provoked vestibulodynia (PVD) which is similar however more localized to just the vestibule area of the vulva enrolled. It will be a total of 140 with PVD and 60 with GVD.

The study will involve 2 visits total over about 1-3 weeks depending on schedules and menstrual cycle. The investigators will not scan a person if menstruating AND having abdominal cramps/emotional liability as this may confound analysis.

The participant will be screened for inclusion /exclusion criteria. After signing the consent the participant will have a history and physical and brief psychological interview to evaluation for any psychological problems present (using standard DSM-IV (diagnostic and statistical manual for mental disorders) criteria. The participant will completed questionnaires to assess mood, pain, pain related behavior and sexual functioning on Survey Monkey. The participant will have a neuro-sensory evaluation of the perineum performed by a qualified gynecologist Medical Doctor or Nurse Practitioner. During the examination the clinician will swab the vaginal canal using 2 sterile swabs (vaginal fluid) for microbiota (normal vaginal healthy bacteria). There will be 1 venous blood draw of about 2 teaspoons via venipuncture by the nurse, to look at blood metabolites and genes. Then the participant will have discomfort threshold testing of the right and left shin and upper arm muscle with an algometer.

Following screening the participant will return within 1-3 weeks to have brain scanning done which involves both functional (resting state) and structural scans. The investigators will measure changes in the autonomic nervous system simultaneously through electrodes on finger tips which measure minute changes in sweat glands. Saliva samples will be collected for analysis of polymorphism in genes controlling inflammation, pain, and nerve functioning. Prior to the scanning the participant will be asked to complete questionnaires to assess current (state) mood and symptoms on Survey Monkey.

The length of time of each visit is assessed to be about 90 minutes each.


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date June 30, 2018
Est. primary completion date June 27, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

1. Sex: Female (VD is a disorder that affects women only).

2. Age: 18 to 55 years of age.

3. 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.

4. 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.

5. Generally healthy without current neurological, cardiovascular, hepatic, renal, autoimmune diseases, diabetes or cancer.

6. Willingness to use acceptable contraceptive methods (e.g., hormonal, barrier, or sterilization) if sexually active.

7. 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.

Exclusion Criteria:

1. 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.

2. 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.

3. Heavy tobacco smokers will be excluded to avoid confounding effects of nicotine withdrawal or recent smoking on assessments during functional MRI.

4. 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.

5. 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.

6. 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.

7. Pregnancy: subjects will be required to have a pregnancy test on the day of the MRI scan.

8. 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.

9. Postmenopausal women defined as no menses for 12 consecutive months.

10. 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.

11. Oral opiates/anxiolytics and steroids are never allowed due to changes in the brain that would confound analysis.

12. Morbid Obesity (BMI > 35%)

13. Current use of certain oral contraceptives, nuvaring, Intrauterine devices (IUD) or spermicide as contraceptive method.

14. Use of antibiotics, antifungal or probiotics within 6 weeks of study enrollment.

15. Engaging in vaginal penetration (such as sexual intercourse, douches, tampons) or use of fragranced feminine hygiene products within 7 days of study enrollment.

16. Recent or active bacterial or fungal infections within 6 weeks of study enrollment.

17. Menstrual cycle beginning within 1 week of study participation.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of California, Los Angeles (UCLA) Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Genotyping for candidate gene polymorphism Genotyping for candidate gene polymorphism related to hypothalamic-pituitary-adrenal (HPA) axis function. 5 minutes at screening for saliva sample collecteion
See also
  Status Clinical Trial Phase
Completed NCT05478746 - Effects of Flourish HEC on Localized Provoked Vulvodynia N/A
Completed NCT02404961 - Women's Health Study: Immunological Factors and Risk of Vulvodynia
Completed NCT00751010 - Relationship: Interstitial Cystitis & Vulvodynia-Part 2 N/A
Completed NCT00607490 - A Randomized Clinical Trial for Women With Vulvodynia N/A
Recruiting NCT03640624 - Multidisciplinary Treatment of Chronic Vulvar Pain N/A
Recruiting NCT05343182 - Vestibulectomy Surgical Techniques Comparison Study N/A
Recruiting NCT05518630 - An Investigation of Nomothetic Versus Idiographic Assessment in Chronic Pain
Recruiting NCT05597358 - Efficacy of High Intensity Laser for Provoked Vestibulodynia N/A
Completed NCT01304589 - Savella in Treatment for Provoked Vestibulodynia Phase 3
Completed NCT00590590 - Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort Phase 2
Recruiting NCT06138171 - Personality, Defences, Central Sensitization, and Trauma in Women With Chronic Migraine, Fibromyalgia, and Vulvodynia
Completed NCT01996384 - Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study Phase 1
Completed NCT01664962 - Search for Genetic Basis of Vulvodynia N/A
Recruiting NCT05955313 - Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia Phase 2
Completed NCT02773641 - Placebo-controlled RCT of Botulinum Toxin A as a Treatment for Provoked Vestibulodynia Phase 3
Completed NCT00501774 - A Search for Helicobacter Pylori in Localized Vulvodynia N/A
Completed NCT04057755 - Botulinum Toxin A as a Treatment for Provoked Vestibulodynia Phase 3
Terminated NCT04016467 - Effect of Spinal Manipulation on Vulvar Pain N/A
Completed NCT01935063 - Study to Compare the Efficacy of Cognitive-behavioral Couple Therapy and Lidocaine for Provoked Vestibulodynia N/A
Completed NCT02809612 - An Internet-based Information Platform for Vulvodynia Patients N/A