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New treatment option for Provoked Vestibulodynia
Official title IncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction
ClinicalTrials.gov ID: NCT07486830
What this study is testing
What is Incobotulinum Toxin A?
Incobotulinum Toxin A is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for provoked vestibulodynia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a double-blind, placebo-controlled study evaluating the safety and efficacy of incobotulinumtoxinA (Merz) for the treatment of provoked vestibulodynia (PVD) associated with overactive pelvic floor muscle dysfunction. Eligible participants are premenopausal females aged 18 years and older with a confirmed diagnosis of PVD with hypertonic pelvic floor muscles, established by both an expert physician and an expert pelvic floor physical therapist.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female, 18 years or older.
- Willing to provide a written informed consent prior to any study related procedures.
- Premenopausal.
- Have vulvodynia with provoked vestibulodynia with overactive pelvic floor muscle dysfunction for at least 3 months duration and for no more than 15...
- Have provoked pain at the posterior vestibule on a cotton swab test, with pain at positions 4, 6 and 8 o'clock (must be bilateral pain) at the...
You likely can't join if
- Have provoked pain on a cotton swab test at the anterior vestibule (anywhere between 9 and 3 o'clock or more anteriorly) at the Baseline Visit.
- Able to tolerate the 6th (diameter 1 1⁄4 inches) dilator size (i.e. agree to the next successive dilator size to be tested for pain response) at the...
- Genitourinary or gastrointestinal conditions/history which, according to the investigator's judgment may interfere with treatment or impact outcome...
- Skin disease at the vestibule such as lichen sclerosus, lichen planus, vaginal or vulvar atrophy, desquamative inflammatory vaginitis, allergic...
- Severe endometriosis (as defined as requiring regular medications other than hormonal contraceptives and NSAIDS to manage the endometriosis symptoms).
- Pudendal neuralgia (as defined as greater than minimal tenderness to palpation of the pudendal nerves at the ischial spine).
See the full eligibility criteria
Who can join
- Female, 18 years or older.
- Willing to provide a written informed consent prior to any study related procedures.
- Premenopausal.
- Have vulvodynia with provoked vestibulodynia with overactive pelvic floor muscle dysfunction for at least 3 months duration and for no more than 15 years.
- Have provoked pain at the posterior vestibule on a cotton swab test, with pain at positions 4, 6 and 8 o'clock (must be bilateral pain) at the Baseline Visit.
- Have independently confirmed diagnoses of provoked vestibulodynia PVD with overactive pelvic floor muscle dysfunction (hypertonic pelvic floor muscles) confirmed by both an expert physician and expert pelvic floor...
- Are able to tolerate the smallest dilator size (diameter 0.5 inches) at the Baseline Visit, i.e. agree to the next successive dilator size to be tested for pain response (i.e. the two smallest sized dilators (#1 and 2)...
- Pain score ≥5 on an 11-point Numeric Rating Scale (NRS) for the Dilator Maximum Tested Size (DMTS) at the Baseline Visit.
- Willing and able to comply with study restrictions, able to attend the clinic for the required duration of assessments during the study period and willing to return to the clinic for the follow-up evaluation as...
- If the subject has received oral antidepressants, anxiolytics or anti-epileptics, then the dose of these medications should have been stable for at least 3 months prior to the Baseline Visit and expected to remain...
- If the subject is currently undergoing pelvic floor physical therapy then the frequency of visits should be stable for at least 8 weeks prior to the Baseline visit and expected to remain stable throughout the study.
- If the subject has vaginal/vulvar infections (bacterial vaginosis, presence of candidiasis or trichomoniasis) at Baseline Visit (provider will take a vaginal culture swab to test for infection), they may still...
What rules you out
- Have provoked pain on a cotton swab test at the anterior vestibule (anywhere between 9 and 3 o'clock or more anteriorly) at the Baseline Visit.
- Able to tolerate the 6th (diameter 1 1⁄4 inches) dilator size (i.e. agree to the next successive dilator size to be tested for pain response) at the Baseline Visit with a pain score less than 5 (i.e. blue dilator).
- Genitourinary or gastrointestinal conditions/history which, according to the investigator's judgment may interfere with treatment or impact outcome assessment, including but not limited to:
- Skin disease at the vestibule such as lichen sclerosus, lichen planus, vaginal or vulvar atrophy, desquamative inflammatory vaginitis, allergic vulvitis, etc.
- Severe endometriosis (as defined as requiring regular medications other than hormonal contraceptives and NSAIDS to manage the endometriosis symptoms).
- Pudendal neuralgia (as defined as greater than minimal tenderness to palpation of the pudendal nerves at the ischial spine).
- Genitourinary or rectal cancer.
- Congenital urogenital abnormalities (e.g. vaginal septa, imperforate hymen, urethral diverticulum).
- Pain in urethra (diagnosis based on subject's interview and physical examination).
- Symptomatic urogenital prolapse at physical examination.
- History of traumatic or post radiotherapy vulvar lesions.
- Previous surgery that according to the investigator's judgment may impact on study outcome including but not limited to vaginal hysterectomy, vestibulectomy, urolxogic surgery (slings, colporrhaphy, etc.), perianal...
- Current vaginal/vulvar infections (bacterial vaginosis, candidiasis, or trichomoniasis) and are unwilling or unable to take oral medication to treat this infection.
- Clinically significant history of alcohol/drug abuse the last 24 weeks prior to Baseline or clinically significant alcohol/drug dependence within 2 years prior to Baseline. Exceptions include caffeine or nicotine...
- Has received any of the following:
- Pelvic floor physical therapy initiated, stopped or modified (frequency or type of physical therapy) during the last 8 weeks prior to Baseline (physical therapy includes but is not limited to: internal/external...
- Treatment with any muscle relaxants in the past 2 weeks.
- Treatment for anterior vestibular pain, with hormonal creams, in the last 1 week prior to Baseline unless continued at the same dosing regimen throughout the study.
- Currently receiving treatment for stress or urge urinary incontinence.
- Injections of steroids in the vulva within the last 4 weeks prior to the Baseline Visit or planned use during the study.
- Injection of BoNT in the genitopelvic area within the last 12 months prior to the Baseline visit.
- Treatment with an investigational drug within the last 4 weeks prior to Baseline or scheduled treatment with such a drug during the study period.
- Is likely to require treatment during the study with drugs that are not permitted by the study protocol.
- Any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude, as judged by the investigator.
- Women who are pregnant or planning to become pregnant during the study, or who are currently lactating (breastfeeding). Participants should either not have sexual intercourse with a male partner or should use a method...
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.