Trial Outcomes & Findings for Study to Determine Efficacy & Safety of a Low Concentration Estriol (0.005%) in Postmenopausal Vaginal Atrophy. (NCT NCT04574999)
NCT ID: NCT04574999
Last Updated: 2020-12-11
Results Overview
Maturation value (MV) is a cytologic parameter indicative of the degree of atrophy of the vaginal mucosa. This variable is a quantitative parameter indicative of the cytological status of the vaginal epithelium. The number of parabasal, intermediate and superficial cells was calculated from 300 consecutive cells of the samples of vaginal cytology, and the percentages of each type of cells obtained. The Maturation Value was obtained based on the following formula: 0.2 x (% parabasal) + 0.6 x (% intermediate) + 1.0 x (% superficial). The higher the value, the higher the maturation degree.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
167 participants
Primary outcome timeframe
At week 12/Early withdrawal
Results posted on
2020-12-11
Participant Flow
There were 167 patients enrolled in the study; 114 patients were randomized to the Estriol group and 53 to the placebo group.
Participant milestones
| Measure |
0.005% Estriol Group
0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Estriol: Gel for vaginal application
|
Placebo Group
Placebo gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Placebo: Gel for vaginal application
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
53
|
|
Overall Study
COMPLETED
|
105
|
48
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
| Measure |
0.005% Estriol Group
0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Estriol: Gel for vaginal application
|
Placebo Group
Placebo gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Placebo: Gel for vaginal application
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Personal problems
|
1
|
0
|
|
Overall Study
Previous planned surgery
|
1
|
0
|
Baseline Characteristics
Study to Determine Efficacy & Safety of a Low Concentration Estriol (0.005%) in Postmenopausal Vaginal Atrophy.
Baseline characteristics by cohort
| Measure |
0.005% Estriol Group
n=114 Participants
0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Estriol: Gel for vaginal application
|
Placebo Group
n=53 Participants
Placebo gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Placebo: Gel for vaginal application
|
Total
n=167 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
|
|
Age, Categorical
Between 18 and 65 years
|
103 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
155 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 5.72 • n=93 Participants
|
57.2 years
STANDARD_DEVIATION 6.70 • n=4 Participants
|
56.7 years
STANDARD_DEVIATION 6.04 • n=27 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
167 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
114 participants
n=93 Participants
|
53 participants
n=4 Participants
|
167 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: At week 12/Early withdrawalPopulation: Intention-to-treat population (ITT): all randomized women that received at least one dose of the study drug (Estriol gel vaginal 0.005% or placebo) after the randomization.
Maturation value (MV) is a cytologic parameter indicative of the degree of atrophy of the vaginal mucosa. This variable is a quantitative parameter indicative of the cytological status of the vaginal epithelium. The number of parabasal, intermediate and superficial cells was calculated from 300 consecutive cells of the samples of vaginal cytology, and the percentages of each type of cells obtained. The Maturation Value was obtained based on the following formula: 0.2 x (% parabasal) + 0.6 x (% intermediate) + 1.0 x (% superficial). The higher the value, the higher the maturation degree.
Outcome measures
| Measure |
0.005% Estriol Group
n=114 Participants
0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Estriol: Gel for vaginal application
|
Placebo Group
n=53 Participants
Placebo gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Placebo: Gel for vaginal application
|
|---|---|---|
|
Change From Baseline to Week 12 in Maturation Value (MV) After 12 Weeks of Treatment
|
26.9 vaginal health index
Standard Deviation 23.33
|
3.2 vaginal health index
Standard Deviation 16.48
|
SECONDARY outcome
Timeframe: At week 12 /early withdrawalPopulation: Intention-to-treat population (ITT): all randomized women that received at least one dose of the study drug (Estriol gel vaginal 0.005% or placebo) after the randomization.
As a consequence of reduced estrogen levels, the vaginal mucosa occurs loses its rugosity, its thickness decreases, and it becomes pale and friable. The production of glycogen decreases, which determines vaginal pH alkalinization.
Outcome measures
| Measure |
0.005% Estriol Group
n=114 Participants
0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Estriol: Gel for vaginal application
|
Placebo Group
n=53 Participants
Placebo gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Placebo: Gel for vaginal application
|
|---|---|---|
|
Change From Baseline to Week 12 of the Vaginal pH After the 12-week Observation Period
|
-1.2 pH units
Standard Deviation 1.4
|
-0.4 pH units
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: At baseline and at 12 weeks / early withdrawalPopulation: Intention-to-treat population (ITT): all randomized women that received at least one dose of the study drug (Estriol gel vaginal 0.005% or placebo) after the randomization.
Signs and symptoms of vaginal atrophy are: vaginal dryness, pruritus or itching, burning, dyspareunia, dysuria. For each of these symptoms the subject indicates one the following status: present, absent, missing. Symptoms of vaginal atrophy were scored by the patients in a numeric scale from 0 to 3, as shown below: 0 Absence. The symptom is not present 1. The symptom is of mild intensity, without interfering in the patient's activity 2. The symptom is of moderate intensity, causing obvious discomfort to the patient's 3. The symptom is very irritating and severe in intensity Signs of vaginal atrophy were evaluated by the investigator and scored on a numerical scale as shown below: 0 Absence. The symptom is not present 1. The sign is present and is considered a mild alteration 2. The sign is present and is considered a moderate alteration 3. The sign is present and is considered a severe alteration
Outcome measures
| Measure |
0.005% Estriol Group
n=114 Participants
0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Estriol: Gel for vaginal application
|
Placebo Group
n=53 Participants
Placebo gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Placebo: Gel for vaginal application
|
|---|---|---|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Vaginal dryness - Baseline - missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Vaginal dryness - week 12 - present
|
71 Participants
|
39 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Burning - week 12 - absent
|
96 Participants
|
40 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Dyspareunia - Baseline - absent
|
11 Participants
|
5 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Dyspareunia - week 12 - absent
|
56 Participants
|
25 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Vaginal dryness - Baseline - present
|
114 Participants
|
53 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Vaginal dryness - Baseline - absent
|
0 Participants
|
0 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Vaginal dryness - week 12 - absent
|
39 Participants
|
12 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Vaginal dryness - week 12 - missing
|
3 Participants
|
2 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Pruritus - Baseline - present
|
55 Participants
|
29 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Pruritus - Baseline - absent
|
59 Participants
|
24 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Pruritus - Baseline - missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Pruritus - week 12 - present
|
18 Participants
|
11 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Pruritus - week 12 - absent
|
92 Participants
|
40 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Pruritus - week 12 - missing
|
3 Participants
|
2 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Burning - Baseline - present
|
48 Participants
|
18 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Burning - Baseline - absent
|
66 Participants
|
35 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Burning - Baseline - missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Burning - week 12 - present
|
14 Participants
|
11 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Burning - week 12 - missing
|
3 Participants
|
2 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Dyspareunia - Baseline - present
|
101 Participants
|
48 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Dyspareunia - Baseline - missing
|
2 Participants
|
0 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Dyspareunia - week 12 - present
|
51 Participants
|
24 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Dyspareunia - week 12 - missing
|
6 Participants
|
4 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Dysuria - Baseline - present
|
27 Participants
|
14 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Dysuria - Baseline - absent
|
85 Participants
|
39 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Dysuria - Baseline - missing
|
2 Participants
|
0 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Dysuria - week 12 - present
|
2 Participants
|
7 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Dysuria - week 12 - absent
|
108 Participants
|
44 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period
Dysuria - week 12 - missing
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At week 3/ early withdrawalPopulation: Intention-to-treat population (ITT): all randomized women that received at least one dose of the study drug (Estriol gel vaginal 0.005% or placebo) after the randomization.
Maturation value (MV) is a cytologic parameter indicative of the degree of atrophy of the vaginal mucosa. This variable is a quantitative parameter indicative of the cytological status of the vaginal epithelium. The number of parabasal, intermediate and superficial cells was calculated from 300 consecutive cells of the samples of vaginal cytology, and the percentages of each type of cells obtained. The Maturation Value was obtained based on the following formula: 0.2 x (% parabasal) + 0.6 x (% intermediate) + 1.0 x (% superficial). The higher the value, the higher the maturation degree.
Outcome measures
| Measure |
0.005% Estriol Group
n=114 Participants
0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Estriol: Gel for vaginal application
|
Placebo Group
n=53 Participants
Placebo gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Placebo: Gel for vaginal application
|
|---|---|---|
|
Change From Baseline to Week 3 in Maturation Value (MV) After 3 Weeks of Treatment
|
37.9 vaginal health index
Standard Deviation 23.96
|
3.6 vaginal health index
Standard Deviation 13.15
|
SECONDARY outcome
Timeframe: At week 3 / early withdrawalPopulation: Intention-to-treat population (ITT): all randomized women that received at least one dose of the study drug (Estriol gel vaginal 0.005% or placebo) after the randomization.
As a consequence of reduced estrogen levels, the vaginal mucosa occurs loses its rugosity, its thickness decreases, and it becomes pale and friable. The production of glycogen decreases, which determines vaginal pH alkalinization.
Outcome measures
| Measure |
0.005% Estriol Group
n=114 Participants
0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Estriol: Gel for vaginal application
|
Placebo Group
n=53 Participants
Placebo gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Placebo: Gel for vaginal application
|
|---|---|---|
|
Change From Baseline to Week 3 of the Vaginal pH After the 3-week Observation Period
|
-1.4 pH units
Standard Deviation 1.4
|
-0.3 pH units
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: At 3 weeksPopulation: Intention-to-treat population (ITT): all randomized women that received at least one dose of the study drug (Estriol gel vaginal 0.005% or placebo) after the randomization.
Signs and symptoms of vaginal atrophy are: vaginal dryness, pruritus or itching, burning, dyspareunia, dysuria. For each of these symptoms the subject indicates one the following status: present, absent, missing. Symptoms of vaginal atrophy were scored by the patients in a numeric scale from 0 to 3, as shown below: 0 Absence. The symptom is not present 1. The symptom is of mild intensity, without interfering in the patient's activity 2. The symptom is of moderate intensity, causing obvious discomfort to the patient's 3. The symptom is very irritating and severe in intensity Signs of vaginal atrophy were evaluated by the investigator and scored on a numerical scale as shown below: 0 Absence. The symptom is not present 1. The sign is present and is considered a mild alteration 2. The sign is present and is considered a moderate alteration 3. The sign is present and is considered a severe alteration
Outcome measures
| Measure |
0.005% Estriol Group
n=114 Participants
0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Estriol: Gel for vaginal application
|
Placebo Group
n=53 Participants
Placebo gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Placebo: Gel for vaginal application
|
|---|---|---|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Burning - week 3 - missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Dyspareunia - week 3 - absent
|
40 Participants
|
16 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Dysuria - week 3 - absent
|
98 Participants
|
46 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Vaginal dryness - Baseline - present
|
114 Participants
|
53 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Vaginal dryness - Baseline - absent
|
0 Participants
|
0 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Vaginal dryness - Baseline - missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Vaginal dryness - week 3 - present
|
84 Participants
|
43 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Vaginal dryness - week 3 - absent
|
21 Participants
|
8 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Vaginal dryness - week 3 - missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Pruritus - Baseline - present
|
55 Participants
|
29 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Pruritus - Baseline - absent
|
59 Participants
|
24 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Pruritus - Baseline - missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Pruritus - week 3 - present
|
21 Participants
|
13 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Pruritus - week 3 - absent
|
84 Participants
|
38 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Pruritus - week 3 - missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Burning - Baseline - present
|
48 Participants
|
18 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Burning - Baseline - absent
|
66 Participants
|
35 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Burning - Baseline - missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Burning - week 3 - present
|
22 Participants
|
11 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Burning - week 3 - absent
|
83 Participants
|
40 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Dyspareunia - Baseline - present
|
101 Participants
|
48 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Dyspareunia - Baseline - absent
|
11 Participants
|
5 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Dyspareunia - Baseline - missing
|
2 Participants
|
0 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Dyspareunia - week 3 - present
|
60 Participants
|
32 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Dyspareunia - week 3 - missing
|
5 Participants
|
3 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Dysuria - Baseline - present
|
27 Participants
|
14 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Dysuria - Baseline - absent
|
85 Participants
|
39 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Dysuria - Baseline - missing
|
2 Participants
|
0 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Dysuria - week 3 - present
|
7 Participants
|
5 Participants
|
|
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period
Dysuria - week 3 - missing
|
0 Participants
|
0 Participants
|
Adverse Events
0.005% Estriol Group
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.005% Estriol Group
n=114 participants at risk
0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Estriol: Gel for vaginal application
|
Placebo Group
n=53 participants at risk
Placebo gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Placebo: Gel for vaginal application
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Crural hernia
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
Other adverse events
| Measure |
0.005% Estriol Group
n=114 participants at risk
0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Estriol: Gel for vaginal application
|
Placebo Group
n=53 participants at risk
Placebo gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.
Placebo: Gel for vaginal application
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
2.6%
3/114 • Number of events 3 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
3.8%
2/53 • Number of events 2 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Infections and infestations
Nasopharyngitis
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
3.8%
2/53 • Number of events 2 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Infections and infestations
Candidiasis
|
1.8%
2/114 • Number of events 2 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Infections and infestations
Cystitis
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
3.8%
2/53 • Number of events 2 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Infections and infestations
Influenza
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Infections and infestations
Gastroenteritis
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Infections and infestations
Genital herpes
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Infections and infestations
Synusitis
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Infections and infestations
Vulval abscess
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
2.6%
3/114 • Number of events 3 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Reproductive system and breast disorders
Breast pain
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 4 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Reproductive system and breast disorders
Adnexa uteri pain
|
0.88%
1/114 • Number of events 2 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Reproductive system and breast disorders
Bartholinitis
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Reproductive system and breast disorders
Breast swelling
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.88%
1/114 • Number of events 2 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Reproductive system and breast disorders
Endometrial hypertrophy
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Reproductive system and breast disorders
Genital rash
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.88%
1/114 • Number of events 10 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
3/114 • Number of events 4 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.5%
4/114 • Number of events 4 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Musculoskeletal and connective tissue disorders
Sensation of heavyness
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
3.8%
2/53 • Number of events 2 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disk protrusion
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.4%
5/114 • Number of events 8 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Skin and subcutaneous tissue disorders
Hyperhydrosis
|
0.88%
1/114 • Number of events 3 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.88%
1/114 • Number of events 3 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
3/114 • Number of events 3 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
3.8%
2/53 • Number of events 2 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Gastrointestinal disorders
Vomiting
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Gastrointestinal disorders
Melaena
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Nervous system disorders
Headache
|
5.3%
6/114 • Number of events 7 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
3.8%
2/53 • Number of events 2 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Nervous system disorders
Migraine
|
1.8%
2/114 • Number of events 3 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Nervous system disorders
Dizziness
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
General disorders
Application site pruritus
|
1.8%
2/114 • Number of events 2 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
General disorders
Application site irritation
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
General disorders
Asthenia
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
General disorders
Fatigue
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
General disorders
Inflammation
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
General disorders
Peripheral coldness
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
General disorders
Swelling
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Vascular disorders
Hot flush
|
1.8%
2/114 • Number of events 2 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
7.5%
4/53 • Number of events 4 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Vascular disorders
Labile hypertension
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Metabolism and nutrition disorders
Overweight
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Ear and labyrinth disorders
Motion sickness
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Ear and labyrinth disorders
Ear pain
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Ear and labyrinth disorders
Vertigo
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Psychiatric disorders
Anxiety
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Psychiatric disorders
Dysthymic disorder
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Injury, poisoning and procedural complications
Nerve root injury lumbar
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Surgical and medical procedures
Bunion operation
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Eye disorders
Vision blurred
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/114 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
1.9%
1/53 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Investigations
Transaminases increased
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
|
Renal and urinary disorders
Leukocyturia
|
0.88%
1/114 • Number of events 1 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
0.00%
0/53 • Throughout the study (baseline, day 1, week 3, week 8, and week 12)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place