This study is designed to define optimal doses of Dysport and evaluate its efficacy and safety compared with placebo for the treatment of vulvodynia. The study will consist of a dose escalation stage (Stage 1) and a dose expansion stage (Stage 2). Both Stage 1 and Stage 2 will consist of a double-blind period (with treatment cycle 1; Dysport or placebo) followed by an open label treatment period. One or two optimally safe and effective doses of Dysport selected from Stage 1 will be further investigated in the Stage 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Botulinum Toxin Type A (Dysport) using a vial of 500 U will be injected intramuscularly across pelvic floor muscles.
The reconstituted solution will be injected intramuscularly across pelvic floor muscles.
James A. Simon, MD, PC
Washington D.C., District of Columbia, United States
The Center for Vulvovaginal Disorders
Washington D.C., District of Columbia, United States
New Age Medical Research Corporation
Miami, Florida, United States
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1)
For Stage 1, the primary endpoint was safety during the DB treatment period as assessed by the incidence of adverse events (AEs). An AE was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition could have been symptoms, signs or abnormal results of an investigation. A TEAE was an event with start date on or after the date of the first investigational medicinal product (IMP). Relatedness to treatment was assessed by the investigator. TEAEs of special interest included events suggesting a possible remote spread of effect of the toxin, events related to urinary incontinence or faecal incontinence and events assessed as a potential hypersensitivity reaction. Results for this outcome are reported as the number of participants experiencing at least one TEAE in each specified category.
Time frame: From Baseline (Cycle 1 Day 1) to Cycle 1 Week 12 (DB treatment period, Stage 1)
Mean Change From Baseline in Vaginal Dilator Induced Pain During the DB Treatment Period at Week 6 (Stage 2)
Time frame: Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 (DB treatment period, Stage 2)
Mean Change From Baseline in Vaginal Dilator Induced Pain as Reported on an 11-point Numeric Rating Scale (NRS) During the DB Treatment Period at Week 6 and Week 12 (Stage 1)
For the dilator test, a vaginal dilator was used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. The dilator test was used to assess the change from Baseline in the vaginal dilator induced pain (using the DMTS reported at Baseline). Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as change from Baseline during the DB treatment period at Week 6 and Week 12.
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University of Kansas Medical Center
Kansas City, Missouri, United States
Omaha OB-GYN Associates, PC
Omaha, Nebraska, United States
The Center for Vulvovaginal Disorders
New York, New York, United States
Women's Institute for Sexual Health (WISH)
Nashville, Tennessee, United States
Seattle Women's: Health, Research, Gynecology®
Seattle, Washington, United States
Clinique de Santé des Femmes
Québec, Canada
Time frame: Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, Stage 1)
Number of Participants Who Reported at Least a 50% Decrease From Baseline in Vaginal Dilator Induced Pain as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)
For the dilator test, a vaginal dilator was used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. The dilator test was used to assess the change from Baseline in the vaginal dilator induced pain (using the DMTS reported at Baseline). Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a ≥50% decrease from Baseline during the DB treatment period at Week 6 and Week 12.
Time frame: Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, Stage 1)
Number of Participants Who Reported at Least a 30% Decrease From Baseline in Vaginal Dilator Induced Pain as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)
For the dilator test, a vaginal dilator was used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. The dilator test was used to assess the change from Baseline in the vaginal dilator induced pain (using the DMTS reported at Baseline). Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a ≥30% decrease from Baseline during the DB treatment period at Week 6 and Week 12.
Time frame: Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, Stage 1)
Number of Participants Who Reported at Least a 2-point Decrease From Baseline in Vaginal Dilator Induced Pain as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)
For the dilator test, a vaginal dilator was used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. The dilator test was used to assess the change from Baseline in the vaginal dilator induced pain (using the DMTS reported at Baseline). Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a ≥2-point decrease from Baseline during the DB treatment period at Week 6 and Week 12.
Time frame: Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, Stage 1)
Mean Change From Baseline in the DTMS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)
For the dilator test, a set of 8 vaginal dilators of increasing diameter (#1 being the smallest and #8 being the largest) were used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. Based on the subjective pain threshold, the largest sized dilator that the participant accepted/tolerated for the test, was defined as the DMTS. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as change from Baseline in the DTMS during the DB treatment period at Week 6 and Week 12.
Time frame: Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, Stage 1)
Mean Change From Baseline in the Composite Score for the Vaginal Dilator Induced Pain and Dilator Size During the DB Treatment Period at Week 6 and Week 12 (Stage 1)
For the dilator test, a set of 8 vaginal dilators of increasing diameter (#1 being the smallest and #8 being the largest) were used by the investigator to provoke pain to allow assessment of vestibular pain intensity in each participant. The composite score for the vaginal dilator induced pain and dilator size was the sum of all pain measurements across the full range of dilator sizes. For any dilator size that was beyond the DMTS, the pain score was 10. There was to be at least 6 pain scores (recorded by the investigator) to calculate the composite score. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as change from Baseline in the composite score for the dilator test during the DB treatment period at Week 6 and Week 12.
Time frame: Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, Stage 1)
Mean Change From Baseline in Pain During Insertion of Vaginal Dilator Number 6 Size as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)
From 2 weeks prior to the next planned visit, all participants rated in the electronic diary (eDiary) once a week the level of the corresponding pain following insertion of the number 6 vaginal dilator into the vagina. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the change from Baseline in participant reported pain score for the number 6 dilator test during the DB treatment period at Week 6 and Week 12.
Time frame: Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, Stage 1)
Number of Participants Who Reported at Least a 50% Decrease From Baseline in Pain During Insertion of Vaginal Dilator Number 6 Size as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)
From 2 weeks prior to the next planned visit, all participants rated in the eDiary once a week the level of the corresponding pain following insertion of the number 6 vaginal dilator into the vagina. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a ≥50% decrease from Baseline in participant reported pain score for the number 6 dilator test during the DB treatment period at Week 6 and Week 12.
Time frame: Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, Stage 1)
Number of Participants Who Reported at Least a 30% Decrease From Baseline in Pain During Insertion of Vaginal Dilator Number 6 Size as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)
From 2 weeks prior to the next planned visit, all participants rated in the eDiary once a week the level of the corresponding pain following insertion of the number 6 vaginal dilator into the vagina. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a ≥30% decrease from Baseline in participants reported pain score for the number 6 dilator test during the DB treatment period at Week 6 and Week 12.
Time frame: Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, Stage 1)
Number of Participants Who Reported at Least a 2-point Decrease From Baseline in Pain During Insertion of Vaginal Dilator Number 6 Size as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)
From 2 weeks prior to the next planned visit, all participants rated in the eDiary once a week the level of the corresponding pain following insertion of the number 6 vaginal dilator into the vagina. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the number of participants who had a 2-point decrease from Baseline in participant reported pain score for the number 6 dilator test during the DB treatment period at Week 6 and Week 12.
Time frame: Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, Stage 1)
Mean Change From Baseline in Pain During Intercourse as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)
From the Screening visit, and then 2 weeks prior to the next planned visit, participants recorded on a daily basis in the eDiary if they had intercourse and if yes, the level of the corresponding pain during each intercourse instance. Participants rated their pain using an 11-point NRS ranging from 0 to 10, where 0 was no pain and 10 was the worst possible pain. Higher scores indicate a worse outcome. The 2-week average was used, which was calculated as the average of the score over the last 2 weeks (14 days) prior to the visit. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the change from Baseline in participant reported pain score during intercourse (over the last 2 weeks prior to each visit) during the DB treatment period at Week 6 and Week 12.
Time frame: Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, Stage 1)
Mean Change From Baseline in the Number of Intercourse Instances in Participants With Partners During the DB Treatment Period at Week 6 and Week 12 (Stage 1)
From the Screening visit, and then 2 weeks prior to the next planned visit, participants recorded on a daily basis in the eDiary if they had intercourse and if yes, the number of intercourse instances in the previous 24-hour period. The number of intercourse instances over the 2 weeks preceding the visit was calculated as the total recorded number of intercourse instances over 14 days prior to the visit. Baseline was defined as the last value available prior to the first study IMP treatment administration. Results for this outcome are reported as the change from Baseline in number of intercourse instances (over the last 2 weeks prior to each visit) during the DB treatment period at Week 6 and Week 12.
Time frame: Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, Stage 1)
Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12
From the Screening visit, and then 2 weeks prior to the next planned visit, participants recorded on a daily basis in the eDiary if they had intercourse and also details of any pain rescue medication consumed for each intercourse instance to prevent or treat the vestibular pain. If a participant used the rescue medication associated with at least one instance during the 2-week prior to a visit, the participant was considered as having used the rescue medication for that visit. Results for this outcome are reported as the number of participants using pain rescue medication associated with intercourse (over the last 2 weeks prior to each visit) during the DB treatment period at Baseline, Week 6 and Week 12.
Time frame: Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, Stage 1)