Vulvodynia
Conditions
Brief summary
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.
Interventions
BIOLOGICALBotulinum toxin type A
Botulinum Toxin Type A (Dysport) using a vial of 500 U will be injected intramuscularly across pelvic floor muscles.
DRUGPlacebo
The reconstituted solution will be injected intramuscularly across pelvic floor muscles.
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Premenopausal * Have vulvodynia for at least 6 months and for no more than 15 years * Have provoked pain at the vestibule on a Q tip test
Exclusion criteria
* Deep pain during intercourse * Have genitourinary or gastrointestinal conditions which may interfere with the study * Previous surgery that according to investigator's judgement may impact on study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | From Baseline (Cycle 1 Day 1) to Cycle 1 Week 12 (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. |
| Mean Change From Baseline in Vaginal Dilator Induced Pain During the DB Treatment Period at Week 6 (Stage 2) | Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 (DB treatment period, Stage 2) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, 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. |
| 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) | Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, 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. |
| Mean Change From Baseline in the DTMS During the DB Treatment Period at Week 6 and Week 12 (Stage 1) | Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, 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. |
| 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) | Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, 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. |
| 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) | Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, 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. |
| 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) | Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, 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. |
| 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) | Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, 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. |
| 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) | Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, 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. |
| 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) | Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, 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. |
| 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) | Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, 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. |
| Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 | Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, 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 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. |
| 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) | Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, 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. |
| 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) | Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, 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. |
Countries
Canada, United States
Participant flow
Recruitment details
This Phase II double-blind (DB) study was conducted in participants with vulvodynia provoked vestibulodynia. 8 sites in the United States and Canada randomised participants. The study consisted of a dose escalation stage (Stage 1) and a dose expansion stage (Stage 2). The purpose of the dose escalation (Stage 1) was to determine the Dysport doses to be further investigated in Stage 2. All analysis was based on available Stage 1 data only. Stage 2 was not started due to early study termination.
Pre-assignment details
For each participant, the study consisted of a DB treatment period (Cycle 1; participants received Dysport or placebo) followed by a follow-up period and/or open-label (OL) treatment period (Cycles 2 to 4; participants received Dysport). A total of 60 participants were randomised and received treatment with placebo or Dysport in the DB treatment period for Stage 1. Up to a maximum of 800 Units (U) Dysport was planned but 500 U was the maximum dose tested due to early study termination.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received placebo (matching with Dysport) injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.
Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety). | 13 |
| Dysport 100 U Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 100 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.
Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety). | 8 |
| Dysport 300 U Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 300 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.
Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety). | 8 |
| Dysport 400 U Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 400 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.
Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety). | 14 |
| Dysport 500 U Stage 1: On Cycle 1 Day 1 in the DB treatment period, participants received Dysport 500 U injected intramuscularly at 10 injection sites across 4 pelvic floor muscles in the vestibular region.
Following Week 12 of the DB treatment period, all participants who met retreatment criteria were treated during the OL period for Cycles 2 to 4 (with each treatment administered at least 12 weeks apart). For a given participant, the Dysport dose during the OL treatment period was based on the investigator's judgement (based on efficacy and safety). | 17 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Study Terminated by Sponsor | 3 | 0 | 0 | 0 | 15 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Dysport 100 U | Dysport 300 U | Dysport 400 U | Dysport 500 U | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 8 Participants | 8 Participants | 14 Participants | 17 Participants | 60 Participants |
| Age, Continuous | 30.8 years STANDARD_DEVIATION 7.12 | 29.6 years STANDARD_DEVIATION 3.11 | 30.4 years STANDARD_DEVIATION 6.61 | 31.1 years STANDARD_DEVIATION 5 | 26.5 years STANDARD_DEVIATION 5.48 | 29.4 years STANDARD_DEVIATION 5.83 |
| Dilator Maximum Tested Size (DMTS) at Baseline | 4.5 scores on a scale STANDARD_DEVIATION 1.27 | 4.4 scores on a scale STANDARD_DEVIATION 1.19 | 4.8 scores on a scale STANDARD_DEVIATION 1.04 | 4.5 scores on a scale STANDARD_DEVIATION 1.02 | 4.1 scores on a scale STANDARD_DEVIATION 1.11 | 4.4 scores on a scale STANDARD_DEVIATION 1.11 |
| Pain reported using DMTS at Baseline | 7.2 scores on a scale STANDARD_DEVIATION 1.83 | 6.5 scores on a scale STANDARD_DEVIATION 0.93 | 7.4 scores on a scale STANDARD_DEVIATION 1.6 | 6.3 scores on a scale STANDARD_DEVIATION 0.99 | 7.4 scores on a scale STANDARD_DEVIATION 1 | 7.0 scores on a scale STANDARD_DEVIATION 1.34 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 12 Participants | 7 Participants | 8 Participants | 13 Participants | 15 Participants | 55 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 11 Participants | 8 Participants | 8 Participants | 13 Participants | 16 Participants | 56 Participants |
| Sex: Female, Male Female | 13 Participants | 8 Participants | 8 Participants | 14 Participants | 17 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 8 | 0 / 8 | 0 / 14 | 0 / 17 |
| other Total, other adverse events | 1 / 13 | 3 / 8 | 3 / 8 | 3 / 14 | 6 / 17 |
| serious Total, serious adverse events | 0 / 13 | 0 / 8 | 0 / 8 | 0 / 14 | 0 / 17 |
Outcome results
Primary
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)
Population: The study was terminated early prior to starting Stage 2; therefore no analysis was performed for this primary outcome.
Primary
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)
Population: The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Any TEAEs | 1 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | TEAEs of special interest | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | TEAEs leading to death | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Treatment-related TEAEs | 1 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Severe TEAEs | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | TEAEs leading to IMP withdrawal | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Serious AEs | 0 Participants |
| Dysport 100 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Serious AEs | 0 Participants |
| Dysport 100 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | TEAEs leading to IMP withdrawal | 0 Participants |
| Dysport 100 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Severe TEAEs | 0 Participants |
| Dysport 100 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Any TEAEs | 3 Participants |
| Dysport 100 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | TEAEs leading to death | 0 Participants |
| Dysport 100 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Treatment-related TEAEs | 0 Participants |
| Dysport 100 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | TEAEs of special interest | 0 Participants |
| Dysport 300 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | TEAEs leading to IMP withdrawal | 0 Participants |
| Dysport 300 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Any TEAEs | 3 Participants |
| Dysport 300 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Severe TEAEs | 0 Participants |
| Dysport 300 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Treatment-related TEAEs | 0 Participants |
| Dysport 300 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Serious AEs | 0 Participants |
| Dysport 300 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | TEAEs leading to death | 0 Participants |
| Dysport 300 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | TEAEs of special interest | 0 Participants |
| Dysport 400 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Treatment-related TEAEs | 0 Participants |
| Dysport 400 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Serious AEs | 0 Participants |
| Dysport 400 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Severe TEAEs | 0 Participants |
| Dysport 400 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | TEAEs of special interest | 0 Participants |
| Dysport 400 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | TEAEs leading to death | 0 Participants |
| Dysport 400 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Any TEAEs | 3 Participants |
| Dysport 400 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | TEAEs leading to IMP withdrawal | 0 Participants |
| Dysport 500 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Treatment-related TEAEs | 3 Participants |
| Dysport 500 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | TEAEs of special interest | 0 Participants |
| Dysport 500 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | TEAEs leading to death | 0 Participants |
| Dysport 500 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Serious AEs | 0 Participants |
| Dysport 500 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Severe TEAEs | 0 Participants |
| Dysport 500 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | Any TEAEs | 6 Participants |
| Dysport 500 U | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1) | TEAEs leading to IMP withdrawal | 0 Participants |
Secondary
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)
Population: The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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) | Week 6 | -2.69 scores on a scale | Standard Deviation 2.549 |
| Placebo | 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) | Week 12 | -2.10 scores on a scale | Standard Deviation 1.983 |
| Dysport 100 U | 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) | Week 12 | -1.17 scores on a scale | Standard Deviation 2.503 |
| Dysport 100 U | 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) | Week 6 | -1.75 scores on a scale | Standard Deviation 2.34 |
| Dysport 300 U | 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) | Week 6 | -2.17 scores on a scale | Standard Deviation 2.893 |
| Dysport 300 U | 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) | Week 12 | -2.80 scores on a scale | Standard Deviation 2.28 |
| Dysport 400 U | 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) | Week 6 | -1.50 scores on a scale | Standard Deviation 1.871 |
| Dysport 400 U | 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) | Week 12 | -1.04 scores on a scale | Standard Deviation 1.196 |
| Dysport 500 U | 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) | Week 12 | -2.38 scores on a scale | Standard Deviation 1.949 |
| Dysport 500 U | 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) | Week 6 | -1.94 scores on a scale | Standard Deviation 1.841 |
Secondary
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)
Population: The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants who had intercourse in the corresponding period, with values at both Baseline and the specified visit were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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) | Week 6 | -5.68 scores on a scale | Standard Deviation 4.502 |
| Placebo | 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) | Week 12 | -3.04 scores on a scale | Standard Deviation 4.246 |
| Dysport 100 U | 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) | Week 6 | -0.43 scores on a scale | Standard Deviation 3.092 |
| Dysport 100 U | 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) | Week 12 | 0.20 scores on a scale | Standard Deviation 2.207 |
| Dysport 300 U | 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) | Week 6 | -2.01 scores on a scale | Standard Deviation 2.025 |
| Dysport 300 U | 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) | Week 12 | -1.58 scores on a scale | Standard Deviation 2.671 |
| Dysport 400 U | 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) | Week 12 | -0.88 scores on a scale | Standard Deviation 3.206 |
| Dysport 400 U | 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) | Week 6 | -0.51 scores on a scale | Standard Deviation 2.186 |
| Dysport 500 U | 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) | Week 6 | -1.91 scores on a scale | Standard Deviation 2.291 |
| Dysport 500 U | 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) | Week 12 | -2.38 scores on a scale | Standard Deviation 2.12 |
Secondary
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)
Population: The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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) | Week 6 | -15.1 scores on a scale | Standard Deviation 11.16 |
| Placebo | 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) | Week 12 | -12.2 scores on a scale | Standard Deviation 10.52 |
| Dysport 100 U | 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) | Week 6 | -13.0 scores on a scale | Standard Deviation 12.9 |
| Dysport 100 U | 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) | Week 12 | -14.0 scores on a scale | Standard Deviation 14.66 |
| Dysport 300 U | 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) | Week 6 | -24.4 scores on a scale | Standard Deviation 15.97 |
| Dysport 300 U | 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) | Week 12 | -23.6 scores on a scale | Standard Deviation 18.09 |
| Dysport 400 U | 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) | Week 12 | -11.6 scores on a scale | Standard Deviation 12.6 |
| Dysport 400 U | 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) | Week 6 | -13.4 scores on a scale | Standard Deviation 15.59 |
| Dysport 500 U | 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) | Week 6 | -11.5 scores on a scale | Standard Deviation 15.09 |
| Dysport 500 U | 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) | Week 12 | -13.7 scores on a scale | Standard Deviation 15.02 |
Secondary
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)
Population: The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in the DTMS During the DB Treatment Period at Week 6 and Week 12 (Stage 1) | Week 6 | 1.5 scores on a scale | Standard Deviation 1.27 |
| Placebo | Mean Change From Baseline in the DTMS During the DB Treatment Period at Week 6 and Week 12 (Stage 1) | Week 12 | 1.0 scores on a scale | Standard Deviation 1 |
| Dysport 100 U | Mean Change From Baseline in the DTMS During the DB Treatment Period at Week 6 and Week 12 (Stage 1) | Week 6 | 1.3 scores on a scale | Standard Deviation 1.04 |
| Dysport 100 U | Mean Change From Baseline in the DTMS During the DB Treatment Period at Week 6 and Week 12 (Stage 1) | Week 12 | 1.4 scores on a scale | Standard Deviation 1.06 |
| Dysport 300 U | Mean Change From Baseline in the DTMS During the DB Treatment Period at Week 6 and Week 12 (Stage 1) | Week 6 | 1.6 scores on a scale | Standard Deviation 1.19 |
| Dysport 300 U | Mean Change From Baseline in the DTMS During the DB Treatment Period at Week 6 and Week 12 (Stage 1) | Week 12 | 1.8 scores on a scale | Standard Deviation 1.49 |
| Dysport 400 U | Mean Change From Baseline in the DTMS During the DB Treatment Period at Week 6 and Week 12 (Stage 1) | Week 12 | 1.1 scores on a scale | Standard Deviation 1.64 |
| Dysport 400 U | Mean Change From Baseline in the DTMS During the DB Treatment Period at Week 6 and Week 12 (Stage 1) | Week 6 | 1.4 scores on a scale | Standard Deviation 1.45 |
| Dysport 500 U | Mean Change From Baseline in the DTMS During the DB Treatment Period at Week 6 and Week 12 (Stage 1) | Week 6 | 1.4 scores on a scale | Standard Deviation 1.46 |
| Dysport 500 U | Mean Change From Baseline in the DTMS During the DB Treatment Period at Week 6 and Week 12 (Stage 1) | Week 12 | 1.5 scores on a scale | Standard Deviation 1.42 |
Secondary
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)
Population: The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants who had a partner, with values at both Baseline and the specified visit were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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) | Week 6 | -1.0 scores on a scale | Standard Deviation 3.89 |
| Placebo | 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) | Week 12 | -1.3 scores on a scale | Standard Deviation 2.45 |
| Dysport 100 U | 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) | Week 6 | 0.3 scores on a scale | Standard Deviation 3.01 |
| Dysport 100 U | 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) | Week 12 | -2.6 scores on a scale | Standard Deviation 2.88 |
| Dysport 300 U | 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) | Week 6 | -0.1 scores on a scale | Standard Deviation 3.63 |
| Dysport 300 U | 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) | Week 12 | -1.5 scores on a scale | Standard Deviation 2.07 |
| Dysport 400 U | 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) | Week 12 | -0.1 scores on a scale | Standard Deviation 1.92 |
| Dysport 400 U | 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) | Week 6 | -0.3 scores on a scale | Standard Deviation 1.25 |
| Dysport 500 U | 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) | Week 6 | -1.1 scores on a scale | Standard Deviation 1.5 |
| Dysport 500 U | 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) | Week 12 | -1.5 scores on a scale | Standard Deviation 1.51 |
Secondary
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.
Time frame: Baseline (Cycle 1 Day 1) and Cycle 1 Week 6 and Week 12 (DB treatment period, Stage 1)
Population: The modified Intent-To-Treat population (mITT) included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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) | Week 6 | -3.3 scores on a scale | Standard Deviation 3.01 |
| Placebo | 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) | Week 12 | -3.2 scores on a scale | Standard Deviation 2.76 |
| Dysport 100 U | 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) | Week 6 | -2.4 scores on a scale | Standard Deviation 2.26 |
| Dysport 100 U | 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) | Week 12 | -2.8 scores on a scale | Standard Deviation 3.01 |
| Dysport 300 U | 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) | Week 6 | -4.1 scores on a scale | Standard Deviation 3.68 |
| Dysport 300 U | 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) | Week 12 | -4.1 scores on a scale | Standard Deviation 3.44 |
| Dysport 400 U | 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) | Week 12 | -1.8 scores on a scale | Standard Deviation 2.29 |
| Dysport 400 U | 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) | Week 6 | -1.9 scores on a scale | Standard Deviation 2.62 |
| Dysport 500 U | 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) | Week 6 | -2.1 scores on a scale | Standard Deviation 2.56 |
| Dysport 500 U | 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) | Week 12 | -2.7 scores on a scale | Standard Deviation 2.08 |
Secondary
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)
Population: The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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) | Week 6 | 5 Participants |
| Placebo | 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) | Week 12 | 5 Participants |
| Dysport 100 U | 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) | Week 6 | 3 Participants |
| Dysport 100 U | 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) | Week 12 | 2 Participants |
| Dysport 300 U | 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) | Week 6 | 2 Participants |
| Dysport 300 U | 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) | Week 12 | 2 Participants |
| Dysport 400 U | 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) | Week 12 | 2 Participants |
| Dysport 400 U | 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) | Week 6 | 3 Participants |
| Dysport 500 U | 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) | Week 6 | 8 Participants |
| Dysport 500 U | 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) | Week 12 | 7 Participants |
Secondary
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)
Population: The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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) | Week 6 | 9 Participants |
| Placebo | 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) | Week 12 | 10 Participants |
| Dysport 100 U | 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) | Week 6 | 5 Participants |
| Dysport 100 U | 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) | Week 12 | 5 Participants |
| Dysport 300 U | 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) | Week 6 | 6 Participants |
| Dysport 300 U | 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) | Week 12 | 6 Participants |
| Dysport 400 U | 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) | Week 12 | 8 Participants |
| Dysport 400 U | 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) | Week 6 | 10 Participants |
| Dysport 500 U | 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) | Week 6 | 9 Participants |
| Dysport 500 U | 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) | Week 12 | 12 Participants |
Secondary
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)
Population: The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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) | Week 6 | 5 Participants |
| Placebo | 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) | Week 12 | 6 Participants |
| Dysport 100 U | 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) | Week 6 | 3 Participants |
| Dysport 100 U | 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) | Week 12 | 2 Participants |
| Dysport 300 U | 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) | Week 6 | 2 Participants |
| Dysport 300 U | 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) | Week 12 | 3 Participants |
| Dysport 400 U | 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) | Week 12 | 2 Participants |
| Dysport 400 U | 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) | Week 6 | 3 Participants |
| Dysport 500 U | 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) | Week 6 | 8 Participants |
| Dysport 500 U | 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) | Week 12 | 6 Participants |
Secondary
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)
Population: The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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) | Week 12 | 7 Participants |
| Placebo | 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) | Week 6 | 9 Participants |
| Dysport 100 U | 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) | Week 6 | 4 Participants |
| Dysport 100 U | 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) | Week 12 | 3 Participants |
| Dysport 300 U | 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) | Week 12 | 5 Participants |
| Dysport 300 U | 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) | Week 6 | 5 Participants |
| Dysport 400 U | 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) | Week 6 | 10 Participants |
| Dysport 400 U | 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) | Week 12 | 8 Participants |
| Dysport 500 U | 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) | Week 12 | 10 Participants |
| Dysport 500 U | 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) | Week 6 | 7 Participants |
Secondary
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)
Population: The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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) | Week 6 | 3 Participants |
| Placebo | 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) | Week 12 | 4 Participants |
| Dysport 100 U | 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) | Week 6 | 1 Participants |
| Dysport 100 U | 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) | Week 12 | 1 Participants |
| Dysport 300 U | 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) | Week 6 | 2 Participants |
| Dysport 300 U | 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) | Week 12 | 2 Participants |
| Dysport 400 U | 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) | Week 12 | 2 Participants |
| Dysport 400 U | 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) | Week 6 | 2 Participants |
| Dysport 500 U | 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) | Week 6 | 4 Participants |
| Dysport 500 U | 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) | Week 12 | 4 Participants |
Secondary
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)
Population: The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants with values at both Baseline and the specified visit were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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) | Week 6 | 6 Participants |
| Placebo | 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) | Week 12 | 6 Participants |
| Dysport 100 U | 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) | Week 6 | 3 Participants |
| Dysport 100 U | 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) | Week 12 | 3 Participants |
| Dysport 300 U | 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) | Week 6 | 5 Participants |
| Dysport 300 U | 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) | Week 12 | 4 Participants |
| Dysport 400 U | 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) | Week 12 | 3 Participants |
| Dysport 400 U | 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) | Week 6 | 4 Participants |
| Dysport 500 U | 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) | Week 6 | 5 Participants |
| Dysport 500 U | 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) | Week 12 | 6 Participants |
Secondary
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)
Population: The mITT population included all randomised participants who received at least one IMP administration and had data for the vaginal dilator induced pain as reported on an 11-point NRS at Baseline and Cycle 1 Week 6 visit. Only participants who had intercourse in the corresponding period, with values at both Baseline and the specified visit were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 | Baseline | 0 Participants |
| Placebo | Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 | Week 12 | 0 Participants |
| Placebo | Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 | Week 6 | 0 Participants |
| Dysport 100 U | Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 | Week 6 | 0 Participants |
| Dysport 100 U | Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 | Baseline | 0 Participants |
| Dysport 100 U | Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 | Week 12 | 0 Participants |
| Dysport 300 U | Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 | Week 6 | 0 Participants |
| Dysport 300 U | Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 | Baseline | 1 Participants |
| Dysport 300 U | Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 | Week 12 | 0 Participants |
| Dysport 400 U | Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 | Baseline | 0 Participants |
| Dysport 400 U | Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 | Week 12 | 0 Participants |
| Dysport 400 U | Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 | Week 6 | 2 Participants |
| Dysport 500 U | Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 | Week 6 | 0 Participants |
| Dysport 500 U | Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 | Baseline | 1 Participants |
| Dysport 500 U | Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 | Week 12 | 0 Participants |