Trial Outcomes & Findings for Dysport in Vulvodynia Phase II Study (NCT NCT03598777)
NCT ID: NCT03598777
Last Updated: 2021-12-09
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
From Baseline (Cycle 1 Day 1) to Cycle 1 Week 12 (DB treatment period, Stage 1)
Results posted on
2021-12-09
Participant Flow
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.
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.
Participant milestones
| Measure |
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).
|
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).
|
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).
|
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).
|
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).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
8
|
8
|
14
|
17
|
|
Overall Study
Received Treatment in Cycle 1 DB Treatment Period
|
13
|
8
|
8
|
14
|
17
|
|
Overall Study
Retreated in Cycle 2 OL Treatment Period
|
13
|
7
|
8
|
13
|
11
|
|
Overall Study
Retreated in Cycle 3 OL Treatment Period
|
8
|
6
|
6
|
12
|
2
|
|
Overall Study
Retreated in Cycle 4 OL Treatment Period
|
1
|
0
|
1
|
3
|
0
|
|
Overall Study
COMPLETED
|
7
|
7
|
8
|
14
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
0
|
0
|
15
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
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).
|
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).
|
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).
|
|---|---|---|---|---|---|
|
Overall Study
Study Terminated by Sponsor
|
3
|
0
|
0
|
0
|
15
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Dysport in Vulvodynia Phase II Study
Baseline characteristics by cohort
| Measure |
Placebo
n=13 Participants
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).
|
Dysport 100 U
n=8 Participants
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).
|
Dysport 300 U
n=8 Participants
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).
|
Dysport 400 U
n=14 Participants
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).
|
Dysport 500 U
n=17 Participants
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).
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
60 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
30.8 years
STANDARD_DEVIATION 7.12 • n=93 Participants
|
29.6 years
STANDARD_DEVIATION 3.11 • n=4 Participants
|
30.4 years
STANDARD_DEVIATION 6.61 • n=27 Participants
|
31.1 years
STANDARD_DEVIATION 5.00 • n=483 Participants
|
26.5 years
STANDARD_DEVIATION 5.48 • n=36 Participants
|
29.4 years
STANDARD_DEVIATION 5.83 • n=10 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
60 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
55 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
11 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
56 Participants
n=10 Participants
|
|
Dilator Maximum Tested Size (DMTS) at Baseline
|
4.5 scores on a scale
STANDARD_DEVIATION 1.27 • n=93 Participants
|
4.4 scores on a scale
STANDARD_DEVIATION 1.19 • n=4 Participants
|
4.8 scores on a scale
STANDARD_DEVIATION 1.04 • n=27 Participants
|
4.5 scores on a scale
STANDARD_DEVIATION 1.02 • n=483 Participants
|
4.1 scores on a scale
STANDARD_DEVIATION 1.11 • n=36 Participants
|
4.4 scores on a scale
STANDARD_DEVIATION 1.11 • n=10 Participants
|
|
Pain reported using DMTS at Baseline
|
7.2 scores on a scale
STANDARD_DEVIATION 1.83 • n=93 Participants
|
6.5 scores on a scale
STANDARD_DEVIATION 0.93 • n=4 Participants
|
7.4 scores on a scale
STANDARD_DEVIATION 1.60 • n=27 Participants
|
6.3 scores on a scale
STANDARD_DEVIATION 0.99 • n=483 Participants
|
7.4 scores on a scale
STANDARD_DEVIATION 1.00 • n=36 Participants
|
7.0 scores on a scale
STANDARD_DEVIATION 1.34 • n=10 Participants
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Placebo
n=13 Participants
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.
|
Dysport 100 U
n=8 Participants
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.
|
Dysport 300 U
n=8 Participants
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.
|
Dysport 400 U
n=14 Participants
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.
|
Dysport 500 U
n=17 Participants
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.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1)
TEAEs leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1)
TEAEs of special interest
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1)
Any TEAEs
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1)
Severe TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1)
Treatment-related TEAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1)
TEAEs leading to IMP withdrawal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1)
Serious AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=13 Participants
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.
|
Dysport 100 U
n=8 Participants
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.
|
Dysport 300 U
n=8 Participants
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.
|
Dysport 400 U
n=14 Participants
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.
|
Dysport 500 U
n=17 Participants
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.
|
|---|---|---|---|---|---|
|
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
|
-2.4 scores on a scale
Standard Deviation 2.26
|
-4.1 scores on a scale
Standard Deviation 3.68
|
-1.9 scores on a scale
Standard Deviation 2.62
|
-2.1 scores on a scale
Standard Deviation 2.56
|
|
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
|
-2.8 scores on a scale
Standard Deviation 3.01
|
-4.1 scores on a scale
Standard Deviation 3.44
|
-1.8 scores on a scale
Standard Deviation 2.29
|
-2.7 scores on a scale
Standard Deviation 2.08
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=13 Participants
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.
|
Dysport 100 U
n=8 Participants
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.
|
Dysport 300 U
n=8 Participants
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.
|
Dysport 400 U
n=14 Participants
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.
|
Dysport 500 U
n=17 Participants
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.
|
|---|---|---|---|---|---|
|
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
|
3 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
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
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=13 Participants
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.
|
Dysport 100 U
n=8 Participants
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.
|
Dysport 300 U
n=8 Participants
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.
|
Dysport 400 U
n=14 Participants
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.
|
Dysport 500 U
n=17 Participants
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.
|
|---|---|---|---|---|---|
|
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
|
4 Participants
|
5 Participants
|
10 Participants
|
7 Participants
|
|
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
|
3 Participants
|
5 Participants
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=13 Participants
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.
|
Dysport 100 U
n=8 Participants
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.
|
Dysport 300 U
n=8 Participants
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.
|
Dysport 400 U
n=14 Participants
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.
|
Dysport 500 U
n=17 Participants
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.
|
|---|---|---|---|---|---|
|
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
|
5 Participants
|
6 Participants
|
10 Participants
|
9 Participants
|
|
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
|
5 Participants
|
6 Participants
|
8 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=13 Participants
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.
|
Dysport 100 U
n=8 Participants
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.
|
Dysport 300 U
n=8 Participants
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.
|
Dysport 400 U
n=14 Participants
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.
|
Dysport 500 U
n=17 Participants
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.
|
|---|---|---|---|---|---|
|
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
|
1.3 scores on a scale
Standard Deviation 1.04
|
1.6 scores on a scale
Standard Deviation 1.19
|
1.4 scores on a scale
Standard Deviation 1.45
|
1.4 scores on a scale
Standard Deviation 1.46
|
|
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 1.00
|
1.4 scores on a scale
Standard Deviation 1.06
|
1.8 scores on a scale
Standard Deviation 1.49
|
1.1 scores on a scale
Standard Deviation 1.64
|
1.5 scores on a scale
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=13 Participants
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.
|
Dysport 100 U
n=8 Participants
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.
|
Dysport 300 U
n=8 Participants
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.
|
Dysport 400 U
n=14 Participants
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.
|
Dysport 500 U
n=17 Participants
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.
|
|---|---|---|---|---|---|
|
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
|
-13.0 scores on a scale
Standard Deviation 12.90
|
-24.4 scores on a scale
Standard Deviation 15.97
|
-13.4 scores on a scale
Standard Deviation 15.59
|
-11.5 scores on a scale
Standard Deviation 15.09
|
|
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
|
-14.0 scores on a scale
Standard Deviation 14.66
|
-23.6 scores on a scale
Standard Deviation 18.09
|
-11.6 scores on a scale
Standard Deviation 12.60
|
-13.7 scores on a scale
Standard Deviation 15.02
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Dysport 100 U
n=7 Participants
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.
|
Dysport 300 U
n=6 Participants
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.
|
Dysport 400 U
n=14 Participants
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.
|
Dysport 500 U
n=16 Participants
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.
|
|---|---|---|---|---|---|
|
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
|
-1.75 scores on a scale
Standard Deviation 2.340
|
-2.17 scores on a scale
Standard Deviation 2.893
|
-1.50 scores on a scale
Standard Deviation 1.871
|
-1.94 scores on a scale
Standard Deviation 1.841
|
|
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
|
-1.17 scores on a scale
Standard Deviation 2.503
|
-2.80 scores on a scale
Standard Deviation 2.280
|
-1.04 scores on a scale
Standard Deviation 1.196
|
-2.38 scores on a scale
Standard Deviation 1.949
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=13 Participants
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.
|
Dysport 100 U
n=8 Participants
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.
|
Dysport 300 U
n=8 Participants
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.
|
Dysport 400 U
n=14 Participants
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.
|
Dysport 500 U
n=17 Participants
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.
|
|---|---|---|---|---|---|
|
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
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
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
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=13 Participants
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.
|
Dysport 100 U
n=8 Participants
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.
|
Dysport 300 U
n=8 Participants
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.
|
Dysport 400 U
n=14 Participants
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.
|
Dysport 500 U
n=17 Participants
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.
|
|---|---|---|---|---|---|
|
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
|
3 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
|
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
|
2 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=13 Participants
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.
|
Dysport 100 U
n=8 Participants
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.
|
Dysport 300 U
n=8 Participants
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.
|
Dysport 400 U
n=14 Participants
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.
|
Dysport 500 U
n=17 Participants
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.
|
|---|---|---|---|---|---|
|
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
|
2 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
|
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
|
3 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=6 Participants
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.
|
Dysport 100 U
n=4 Participants
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.
|
Dysport 300 U
n=6 Participants
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.
|
Dysport 400 U
n=6 Participants
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.
|
Dysport 500 U
n=9 Participants
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.
|
|---|---|---|---|---|---|
|
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
|
0.20 scores on a scale
Standard Deviation 2.207
|
-1.58 scores on a scale
Standard Deviation 2.671
|
-0.88 scores on a scale
Standard Deviation 3.206
|
-2.38 scores on a scale
Standard Deviation 2.120
|
|
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
|
-0.43 scores on a scale
Standard Deviation 3.092
|
-2.01 scores on a scale
Standard Deviation 2.025
|
-0.51 scores on a scale
Standard Deviation 2.186
|
-1.91 scores on a scale
Standard Deviation 2.291
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=11 Participants
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.
|
Dysport 100 U
n=6 Participants
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.
|
Dysport 300 U
n=7 Participants
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.
|
Dysport 400 U
n=11 Participants
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.
|
Dysport 500 U
n=14 Participants
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.
|
|---|---|---|---|---|---|
|
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
|
-2.6 scores on a scale
Standard Deviation 2.88
|
-1.5 scores on a scale
Standard Deviation 2.07
|
-0.1 scores on a scale
Standard Deviation 1.92
|
-1.5 scores on a scale
Standard Deviation 1.51
|
|
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
|
0.3 scores on a scale
Standard Deviation 3.01
|
-0.1 scores on a scale
Standard Deviation 3.63
|
-0.3 scores on a scale
Standard Deviation 1.25
|
-1.1 scores on a scale
Standard Deviation 1.50
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=7 Participants
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.
|
Dysport 100 U
n=5 Participants
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.
|
Dysport 300 U
n=7 Participants
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.
|
Dysport 400 U
n=9 Participants
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.
|
Dysport 500 U
n=10 Participants
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.
|
|---|---|---|---|---|---|
|
Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12
Week 6
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12
Week 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12
Baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dysport 100 U
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dysport 300 U
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dysport 400 U
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dysport 500 U
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=13 participants at risk
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).
|
Dysport 100 U
n=8 participants at risk
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).
|
Dysport 300 U
n=8 participants at risk
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).
|
Dysport 400 U
n=14 participants at risk
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).
|
Dysport 500 U
n=17 participants at risk
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).
|
|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
7.7%
1/13 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/14 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
11.8%
2/17 • Number of events 2 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
12.5%
1/8 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/14 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/17 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/13 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/14 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
5.9%
1/17 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
|
Infections and infestations
Ear infection
|
0.00%
0/13 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/14 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
5.9%
1/17 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
|
Infections and infestations
Fungal infection
|
0.00%
0/13 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
12.5%
1/8 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/14 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/17 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
|
Infections and infestations
Molluscum contagiosum
|
7.7%
1/13 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/14 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/17 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
12.5%
1/8 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/14 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/17 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
12.5%
1/8 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/14 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/17 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/13 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/14 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
5.9%
1/17 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/13 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/14 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
5.9%
1/17 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/13 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/14 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
5.9%
1/17 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/13 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
7.1%
1/14 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/17 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
7.7%
1/13 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/14 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/17 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
12.5%
1/8 • Number of events 2 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
7.1%
1/14 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/17 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
|
Nervous system disorders
Retinal migraine
|
7.7%
1/13 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/14 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/17 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/13 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
7.1%
1/14 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/17 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
12.5%
1/8 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/14 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/17 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/13 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/8 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
12.5%
1/8 • Number of events 1 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/14 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
0.00%
0/17 • TEAEs were collected from first administration of IMP (Cycle 1 Day 1) up to end of the DB treatment period; duration of 12 weeks.
The safety population included all randomised participants who received at least one IMP administration (including only partial administration).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place