Provoked VestibulodyniaPhase 2NCT07486830
IncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction
A Phase 2 study testing Incobotulinum Toxin A in people with Provoked Vestibulodynia, run by Center for Vulvovaginal Disorders at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Provoked Vestibulodynia
- What is being tested?
- Incobotulinum Toxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Feb 2026to 3 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 physical therapist.
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- 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) are to be tested).
- 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 specified in the protocol.
- 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 stable throughout the study.
- 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 participate as long as they undergo treatment for the infection (as prescribed by study provider).
Who cannot join
- 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).
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- 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 surgery or genital trauma or mutilation/cutting.
- 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 abuse/dependence.
- 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 myofascial release by physical therapist, biofeedback, home pelvic floor exercises, self-taught exercises, use of vaginal dilators, etc.).
- 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 of birth control that is acceptable to them and the study doctor during the time that they participate in the protocol. Acceptable forms of contraceptives include: progestin and/or estrogen-containing hormonal contraceptives, contraceptive patch, contraceptive implant, contraceptive injection, condoms, or progestin or copper-containing intrauterine device (IUD), tubal sterilization, vasectomy of all sexual partners.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Centers for Vulvovaginal Disorders, NY
New York, New York, 10036
Andrew Goldstein, MD, 4102790209, obstetrics@yahoo.com
Analea Beckman, analea@vulvodynia.com
- Recruiting
Center for VulvoVaginal Disorders
Washington D.C., District of Columbia, 21012
Andrew T Goldstein, MD, 202-887-0568
Ruth Bradford, 202-887-0568
About this study
Official title: A Double Blind, Placebo Controlled Study of IncobotulinumtoxinA in Patients With Provoked Vestibulodynia Associated With Overactive Pelvic Floor Muscle Dysfunction
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. Participants must have bilateral provoked pain at the posterior vestibule on cotton swab testing and a pain score of 5 or greater on an 11-point Numeric Rating Scale (NRS) during standardized dilator testing at baseline. Key outcome measures include change in pain during dilator testing and Patient Global Impression of Change (PGI-C). Participants with anterior vestibular pain, prior botulinum toxin injection in the genitopelvic area within the past 12 months, or significant genitourinary conditions that may confound assessment are excluded.
- Conditions
- Provoked Vestibulodynia
- Being tested
- Incobotulinum Toxin A, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incobotulinum Toxin ADrug
injections into pelvic floor muscles
PlaceboDrug
placebo saline injection into pelvic floor muscles
| Study group | Role | What they receive |
|---|---|---|
| INA group | Experimental | Not described Receives: Drug: Incobotulinum Toxin A |
| Placebo Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dilator Maximum Tested Size
maximum dilator size tolerated
Measured: baseline, week 24-30 (final visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start27 Feb 2026
- Primary completion20 Dec 2026 (estimated)
- Study completion3 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Provoked VestibulodyniaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Vulvovaginal Disorders
- Sponsor type
- University, hospital or other
- Collaborators
- Merz Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486830
- Sponsor's protocol ID
- CCVD-INA-PVD-001
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled Study of IncobotulinumtoxinA in Patients With Provoked Vestibulodynia Associated With Overactive Pelvic Floor Muscle Dysfunction
- ClinicalTrials.gov ID
- NCT07486830
- Acronym / sponsor ID
- CCVD-INA-PVD-001
- Conditions
- Provoked Vestibulodynia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Center for Vulvovaginal DisordersUniversity, hospital or other
- Collaborators
- Merz Pharmaceuticals
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 3 Mar 2027 (estimated)
- First posted
- 23 Mar 2026 (actual)
- 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.
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. Participants must have bilateral provoked pain at the posterior vestibule on cotton swab testing and a pain score of 5 or greater on an 11-point Numeric Rating Scale (NRS) during standardized dilator testing at baseline. Key outcome measures include change in pain during dilator testing and Patient Global Impression of Change (PGI-C). Participants with anterior vestibular pain, prior botulinum toxin injection in the genitopelvic area within the past 12 months, or significant genitourinary conditions that may confound assessment are excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INA group | Experimental | Drug: Incobotulinum Toxin A |
| Placebo Group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female, 18 years or older.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incobotulinum Toxin Ainjections into pelvic floor muscles | Drug | INA group |
| Placeboplacebo saline injection into pelvic floor muscles | Drug | Placebo Group |
Primary outcome
Dilator Maximum Tested Size
Time frame: baseline, week 24-30 (final visit)
maximum dilator size tolerated
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Incobotulinum Toxin A in people with Provoked Vestibulodynia, run by Center for Vulvovaginal Disorders at 2 sites 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 12 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Goldstein, MD (202-887-0568, obstetrics@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dilator Maximum Tested Size (time frame: baseline, week 24-30 (final visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2026.