VulvodyniaVulvodyniaNCT02733172
Profiling Vulvodynia Based on Neurobiological and Behavioral Endophenotypes
An observational study of Vulvodynia, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Vulvodynia
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles (UCLA)
Los Angeles, California, 90025
About this study
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.
Read the detailed 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.
- Conditions
- Vulvodynia
- Keywords
- Vulvodynia, Endophenotypes, functional MRI
- Medical subject headings
- Vulvodynia
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain morphometry measured by magnetic resonance imaging (MRI)
Structural MRI collected to quantify these measures
Measured: 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
Measured: Length of the brain imaging scans is 35 minutes; assessed 1 time
Secondary outcomes (1)
Genotyping for candidate gene polymorphism
Genotyping for candidate gene polymorphism related to hypothalamic-pituitary-adrenal (HPA) axis function.
Measured: 5 minutes at screening for saliva sample collecteion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startJul 2013
- Primary completion27 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Labus, PhD, University of California, Los Angeles
- Investigators
- Jennifer Labus, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733172
- Sponsor's protocol ID
- 13-001113
- Acronym
- Vulvodynia
- Status last verified
- Oct 2019
- First submitted
- 2 Dec 2015
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 35972459
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling Vulvodynia Based on Neurobiological and Behavioral Endophenotypes
- ClinicalTrials.gov ID
- NCT02733172
- Acronym / sponsor ID
- Vulvodynia / 13-001113
- Conditions
- Vulvodynia
- Keywords
- Vulvodynia, Endophenotypes, functional MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- 27 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain morphometry measured by magnetic resonance imaging (MRI)
Time frame: Length of the brain imaging scans is 35 minutes; assessed 1 time
Structural MRI collected to quantify these measures
Functional connectivity measured by magnetic resonance imaging (MRI)
Time frame: Length of the brain imaging scans is 35 minutes; assessed 1 time
Functional MRI collected to quantify these measures
1 secondary outcome
Genotyping for candidate gene polymorphism
Time frame: 5 minutes at screening for saliva sample collecteion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Derived from this study: PubMed 35972459Oughourlian 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.
- Individual participant dataSharing planned: Yes
Related trials for Vulvodynia
Active, not recruiting
Vestibulectomy Surgical Techniques Comparison Study
Vulvar Pain, Vulvodynia
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Not yet recruitingPhase 2
A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia
Vulvodynia
Not yet recruiting
CPP Among Somali Women in Norway: SCED
Chronic Pelvic Pain
Active, not recruiting
Lasertherapy for Vulvodynia
Vulvodynia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Labus, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvodynia, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain morphometry measured by magnetic resonance imaging (MRI) (time frame: Length of the brain imaging scans is 35 minutes; assessed 1 time). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02733172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2019.