Trial Outcomes & Findings for Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy (NCT NCT03332303)
NCT ID: NCT03332303
Last Updated: 2024-05-30
Results Overview
The primary efficacy endpoint is the number of participants in each treatment group that were identified as Responders at the end of the treatment period evaluated on Day 8 or Day 9. A Responder was defined as a participant with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH \< 5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
540 participants
Primary outcome timeframe
Study Day 8 or Study Day 9
Results posted on
2024-05-30
Participant Flow
A total of 540 participants were randomized at 26 investigative sites (medical clinic/research) located in the US. 215 participants were assigned to the test drug arm, 216 participants were assigned to the reference drug arm, and 109 participants were assigned to the placebo arm. The first subject was enrolled on 26-OCT-2017 and the last subject visit was 15-MAR-2018. The study duration was approximately 5 months.
Following the 28-day screening period, participants who continued to meet the inclusion/exclusion (I/E) criteria were randomly assigned to treatment on a 2:2:1 ratio of test Estradiol Vaginal Cream USP, 0.01%; Estrace Vaginal Cream USP, 0.01%; or Placebo test vehicle vaginal cream.
Participant milestones
| Measure |
Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)
Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days.
Intervention: Drug: Estradiol Vaginal Cream, USP, 0.01%
Estradiol Vaginal Cream: Estradiol Vaginal Cream
|
Active Comparator: Estrace® Cream
Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days.
Intervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)
Estrace® Cream: Estrace® Cream
|
Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream
Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days.
Intervention: Drug: Placebo (Test vehicle cream) Vaginal Cream
Vehicle Cream: Vehicle Cream
|
|---|---|---|---|
|
Overall Study
STARTED
|
215
|
216
|
109
|
|
Overall Study
Safety Population
|
215
|
216
|
109
|
|
Overall Study
Modified Intention to Treat (mITT) Population
|
214
|
213
|
109
|
|
Overall Study
Per Protocol (PP) Population
|
196
|
196
|
104
|
|
Overall Study
COMPLETED
|
196
|
196
|
104
|
|
Overall Study
NOT COMPLETED
|
19
|
20
|
5
|
Reasons for withdrawal
| Measure |
Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)
Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days.
Intervention: Drug: Estradiol Vaginal Cream, USP, 0.01%
Estradiol Vaginal Cream: Estradiol Vaginal Cream
|
Active Comparator: Estrace® Cream
Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days.
Intervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)
Estrace® Cream: Estrace® Cream
|
Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream
Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days.
Intervention: Drug: Placebo (Test vehicle cream) Vaginal Cream
Vehicle Cream: Vehicle Cream
|
|---|---|---|---|
|
Overall Study
Participant did not dose
|
1
|
2
|
0
|
|
Overall Study
Participant did not have at least one post-randomization evaluation
|
0
|
1
|
0
|
|
Overall Study
Participant developed concurrent vaginal infection/illness
|
4
|
1
|
0
|
|
Overall Study
Participant did not administer 75-125% of intended dose
|
0
|
3
|
0
|
|
Overall Study
Participant did not complete Study Visit 3 within Day 8 - Day 9 window
|
10
|
10
|
3
|
|
Overall Study
Participant did not meet all inclusion/exclusion criteria
|
4
|
2
|
2
|
|
Overall Study
Participant had a significant protocol deviation
|
0
|
1
|
0
|
Baseline Characteristics
All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable basal/parabasal cells data.
Baseline characteristics by cohort
| Measure |
Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)
n=215 Participants
Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days.
Intervention: Drug: Estradiol Vaginal Cream, USP, 0.01%
Estradiol Vaginal Cream: Estradiol Vaginal Cream
|
Active Comparator: Estrace® Cream
n=216 Participants
Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days.
Intervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)
Estrace® Cream: Estrace® Cream
|
Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream
n=109 Participants
Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days.
Intervention: Drug: Placebo (Test vehicle cream) Vaginal Cream
Vehicle Cream: Vehicle Cream
|
Total
n=540 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 5.5 • n=215 Participants
|
60.7 years
STANDARD_DEVIATION 6.2 • n=216 Participants
|
61.2 years
STANDARD_DEVIATION 6.1 • n=109 Participants
|
61.0 years
STANDARD_DEVIATION 5.9 • n=540 Participants
|
|
Sex: Female, Male
Female
|
215 Participants
n=215 Participants
|
216 Participants
n=216 Participants
|
109 Participants
n=109 Participants
|
540 Participants
n=540 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=215 Participants
|
0 Participants
n=216 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=540 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=215 Participants
|
34 Participants
n=216 Participants
|
23 Participants
n=109 Participants
|
91 Participants
n=540 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
181 Participants
n=215 Participants
|
182 Participants
n=216 Participants
|
86 Participants
n=109 Participants
|
449 Participants
n=540 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=215 Participants
|
0 Participants
n=216 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=540 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=215 Participants
|
1 Participants
n=216 Participants
|
0 Participants
n=109 Participants
|
1 Participants
n=540 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=215 Participants
|
2 Participants
n=216 Participants
|
1 Participants
n=109 Participants
|
7 Participants
n=540 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=215 Participants
|
1 Participants
n=216 Participants
|
0 Participants
n=109 Participants
|
1 Participants
n=540 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=215 Participants
|
28 Participants
n=216 Participants
|
9 Participants
n=109 Participants
|
62 Participants
n=540 Participants
|
|
Race (NIH/OMB)
White
|
185 Participants
n=215 Participants
|
182 Participants
n=216 Participants
|
99 Participants
n=109 Participants
|
466 Participants
n=540 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=215 Participants
|
2 Participants
n=216 Participants
|
0 Participants
n=109 Participants
|
3 Participants
n=540 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=215 Participants
|
0 Participants
n=216 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=540 Participants
|
|
Region of Enrollment
United States
|
215 participants
n=215 Participants
|
216 participants
n=216 Participants
|
109 participants
n=109 Participants
|
540 participants
n=540 Participants
|
|
Natural or Surgical Menopause
Natural Menopause
|
154 Participants
n=215 Participants
|
141 Participants
n=216 Participants
|
78 Participants
n=109 Participants
|
373 Participants
n=540 Participants
|
|
Natural or Surgical Menopause
Surgical Menopause
|
61 Participants
n=215 Participants
|
75 Participants
n=216 Participants
|
31 Participants
n=109 Participants
|
167 Participants
n=540 Participants
|
|
Vaginal Dryness
None
|
0 Participants
n=215 Participants
|
3 Participants
n=216 Participants
|
1 Participants
n=109 Participants
|
4 Participants
n=540 Participants
|
|
Vaginal Dryness
Mild
|
7 Participants
n=215 Participants
|
6 Participants
n=216 Participants
|
3 Participants
n=109 Participants
|
16 Participants
n=540 Participants
|
|
Vaginal Dryness
Moderate
|
127 Participants
n=215 Participants
|
114 Participants
n=216 Participants
|
53 Participants
n=109 Participants
|
294 Participants
n=540 Participants
|
|
Vaginal Dryness
Severe
|
81 Participants
n=215 Participants
|
93 Participants
n=216 Participants
|
52 Participants
n=109 Participants
|
226 Participants
n=540 Participants
|
|
Vaginal/Vulvar Irritation/Itching
None
|
107 Participants
n=215 Participants
|
104 Participants
n=216 Participants
|
48 Participants
n=109 Participants
|
259 Participants
n=540 Participants
|
|
Vaginal/Vulvar Irritation/Itching
Mild
|
53 Participants
n=215 Participants
|
49 Participants
n=216 Participants
|
27 Participants
n=109 Participants
|
129 Participants
n=540 Participants
|
|
Vaginal/Vulvar Irritation/Itching
Moderate
|
45 Participants
n=215 Participants
|
54 Participants
n=216 Participants
|
28 Participants
n=109 Participants
|
127 Participants
n=540 Participants
|
|
Vaginal/Vulvar Irritation/Itching
Severe
|
10 Participants
n=215 Participants
|
9 Participants
n=216 Participants
|
6 Participants
n=109 Participants
|
25 Participants
n=540 Participants
|
|
Dysuria
None
|
173 Participants
n=215 Participants
|
174 Participants
n=216 Participants
|
77 Participants
n=109 Participants
|
424 Participants
n=540 Participants
|
|
Dysuria
Mild
|
30 Participants
n=215 Participants
|
29 Participants
n=216 Participants
|
21 Participants
n=109 Participants
|
80 Participants
n=540 Participants
|
|
Dysuria
Moderate
|
10 Participants
n=215 Participants
|
12 Participants
n=216 Participants
|
9 Participants
n=109 Participants
|
31 Participants
n=540 Participants
|
|
Dysuria
Severe
|
2 Participants
n=215 Participants
|
1 Participants
n=216 Participants
|
2 Participants
n=109 Participants
|
5 Participants
n=540 Participants
|
|
Vaginal Pain During Sexual Activity
None
|
12 Participants
n=215 Participants
|
9 Participants
n=216 Participants
|
4 Participants
n=109 Participants
|
25 Participants
n=540 Participants
|
|
Vaginal Pain During Sexual Activity
Mild
|
11 Participants
n=215 Participants
|
6 Participants
n=216 Participants
|
11 Participants
n=109 Participants
|
28 Participants
n=540 Participants
|
|
Vaginal Pain During Sexual Activity
Moderate
|
59 Participants
n=215 Participants
|
69 Participants
n=216 Participants
|
22 Participants
n=109 Participants
|
150 Participants
n=540 Participants
|
|
Vaginal Pain During Sexual Activity
Severe
|
81 Participants
n=215 Participants
|
83 Participants
n=216 Participants
|
49 Participants
n=109 Participants
|
213 Participants
n=540 Participants
|
|
Vaginal Pain During Sexual Activity
Not Reported
|
52 Participants
n=215 Participants
|
49 Participants
n=216 Participants
|
23 Participants
n=109 Participants
|
124 Participants
n=540 Participants
|
|
Vaginal Bleeding During or After Sexual Activity
Absent
|
131 Participants
n=215 Participants
|
136 Participants
n=216 Participants
|
67 Participants
n=109 Participants
|
334 Participants
n=540 Participants
|
|
Vaginal Bleeding During or After Sexual Activity
Present
|
32 Participants
n=215 Participants
|
31 Participants
n=216 Participants
|
19 Participants
n=109 Participants
|
82 Participants
n=540 Participants
|
|
Vaginal Bleeding During or After Sexual Activity
Not Reported
|
52 Participants
n=215 Participants
|
49 Participants
n=216 Participants
|
23 Participants
n=109 Participants
|
124 Participants
n=540 Participants
|
|
Most Bothersome Sign or Symptom
Vaginal Dryness
|
130 Participants
n=215 Participants
|
131 Participants
n=216 Participants
|
63 Participants
n=109 Participants
|
324 Participants
n=540 Participants
|
|
Most Bothersome Sign or Symptom
Vaginal/Vulvar Irritation/Itching
|
13 Participants
n=215 Participants
|
14 Participants
n=216 Participants
|
9 Participants
n=109 Participants
|
36 Participants
n=540 Participants
|
|
Most Bothersome Sign or Symptom
Dysuria
|
1 Participants
n=215 Participants
|
1 Participants
n=216 Participants
|
0 Participants
n=109 Participants
|
2 Participants
n=540 Participants
|
|
Most Bothersome Sign or Symptom
Vaginal Pain during Sexual Activity
|
71 Participants
n=215 Participants
|
70 Participants
n=216 Participants
|
37 Participants
n=109 Participants
|
178 Participants
n=540 Participants
|
|
Most Bothersome Sign or Symptom
Vaginal Bleeding during or after Sexual Activity
|
0 Participants
n=215 Participants
|
0 Participants
n=216 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=540 Participants
|
|
% of Basal/Parabasal Cells
|
41.6 percent
STANDARD_DEVIATION 36.1 • n=214 Participants • All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable basal/parabasal cells data.
|
36.0 percent
STANDARD_DEVIATION 36.9 • n=215 Participants • All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable basal/parabasal cells data.
|
39.3 percent
STANDARD_DEVIATION 36.0 • n=109 Participants • All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable basal/parabasal cells data.
|
38.9 percent
STANDARD_DEVIATION 36.4 • n=538 Participants • All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable basal/parabasal cells data.
|
|
% of Intermediate Cells
|
57.4 percent
STANDARD_DEVIATION 35.5 • n=214 Participants • All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable intermediate cells data.
|
62.8 percent
STANDARD_DEVIATION 36.3 • n=215 Participants • All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable intermediate cells data.
|
59.5 percent
STANDARD_DEVIATION 35.4 • n=109 Participants • All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable intermediate cells data.
|
62.7 percent
STANDARD_DEVIATION 34.8 • n=538 Participants • All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable intermediate cells data.
|
|
% of Superficial Cells
|
1.1 percent
STANDARD_DEVIATION 1.5 • n=214 Participants • All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable superficial cells data.
|
1.1 percent
STANDARD_DEVIATION 1.6 • n=215 Participants • All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable superficial cells data.
|
1.2 percent
STANDARD_DEVIATION 1.4 • n=109 Participants • All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable superficial cells data.
|
1.1 percent
STANDARD_DEVIATION 1.5 • n=538 Participants • All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable superficial cells data.
|
|
Vaginal pH
|
6.2 pH
STANDARD_DEVIATION 0.7 • n=215 Participants
|
6.2 pH
STANDARD_DEVIATION 0.7 • n=216 Participants
|
6.2 pH
STANDARD_DEVIATION 0.7 • n=109 Participants
|
6.2 pH
STANDARD_DEVIATION 0.62 • n=540 Participants
|
PRIMARY outcome
Timeframe: Study Day 8 or Study Day 9Population: Therapeutic Equivalence Between Experimental and Active Comparator Arms: Per Protocol (PP) Population Superiority over Placebo: Modified Intent-to-treat population (mITT, all randomized study participants who administered at least one dose of randomized study product and had a post-randomization evaluation)
The primary efficacy endpoint is the number of participants in each treatment group that were identified as Responders at the end of the treatment period evaluated on Day 8 or Day 9. A Responder was defined as a participant with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH \< 5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.
Outcome measures
| Measure |
Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)
n=214 Participants
Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days.
Intervention: Drug: Estradiol Vaginal Cream, USP, 0.01%
Estradiol Vaginal Cream: Estradiol Vaginal Cream
|
Active Comparator: Estrace® Cream
n=213 Participants
Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days.
Intervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)
Estrace® Cream: Estrace® Cream
|
Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream
n=109 Participants
Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days.
Intervention: Drug: Placebo (Test vehicle cream) Vaginal Cream
Vehicle Cream: Vehicle Cream
|
|---|---|---|---|
|
The Primary Efficacy Endpoint
Equivalence: PP Population
|
49 participants
|
59 participants
|
—
|
|
The Primary Efficacy Endpoint
Superiority: mITT Population
|
52 participants
|
63 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Study Day 8 or Study Day 9Population: Therapeutic Equivalence Between Experimental and Active Comparator Arms: Per Protocol (PP) Population Superiority over Placebo: Modified Intent-to-treat population (mITT, all randomized study participants who administered at least one dose of randomized study product and had a post-randomization evaluation)
The secondary efficacy endpoint is the number of participants in each treatment group that are considered a Treatment Success at the end of the treatment period evaluated on Day 8 or Day 9. A "Treatment Success" is defined as a score of 0 or 1 on Day 8 or Day 9 for the symptom identified at baseline as the most bothersome. This evaluation will be based on (one) participant self-assessed symptom of VVA (vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, or vaginal pain associated with sexual activity) on a scale of 0 to 3 where 0 = none and 3 = severe. Evaluation of vaginal bleeding during sexual activity will be based on a score of 1 (presence) if it is identified by the participant as the most bothersome symptom at baseline and a score of 0 (absent) on Day 8 or Day 9.
Outcome measures
| Measure |
Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)
n=214 Participants
Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days.
Intervention: Drug: Estradiol Vaginal Cream, USP, 0.01%
Estradiol Vaginal Cream: Estradiol Vaginal Cream
|
Active Comparator: Estrace® Cream
n=213 Participants
Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days.
Intervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)
Estrace® Cream: Estrace® Cream
|
Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream
n=109 Participants
Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days.
Intervention: Drug: Placebo (Test vehicle cream) Vaginal Cream
Vehicle Cream: Vehicle Cream
|
|---|---|---|---|
|
The Secondary Efficacy Endpoint
Equivalence: PP Population
|
112 participants
|
116 participants
|
—
|
|
The Secondary Efficacy Endpoint
Superiority: mITT Population
|
122 participants
|
127 participants
|
63 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (Day - 28 to Day -1)Population: Participants who reported Natural Cause for Menopause during Medical History and Demographics Screening
Baseline Characteristic for Participants who reported Natural Cause for Menopause (Total n = 373 patients) with mean and standard deviation (SD) evaluated per Arm/Group at Visit 1 (Day -28 to Day -1) during Medical History and Demographics Screening
Outcome measures
| Measure |
Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)
n=154 Participants
Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days.
Intervention: Drug: Estradiol Vaginal Cream, USP, 0.01%
Estradiol Vaginal Cream: Estradiol Vaginal Cream
|
Active Comparator: Estrace® Cream
n=141 Participants
Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days.
Intervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)
Estrace® Cream: Estrace® Cream
|
Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream
n=78 Participants
Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days.
Intervention: Drug: Placebo (Test vehicle cream) Vaginal Cream
Vehicle Cream: Vehicle Cream
|
|---|---|---|---|
|
Duration of Post-menopausal Status (Years)
|
11.1 years
Standard Deviation 6.4
|
11.4 years
Standard Deviation 6.5
|
12.3 years
Standard Deviation 7.6
|
Adverse Events
Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)
Serious events: 0 serious events
Other events: 66 other events
Deaths: 0 deaths
Active Comparator: Estrace® Cream
Serious events: 1 serious events
Other events: 59 other events
Deaths: 0 deaths
Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)
n=215 participants at risk
Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days.
Intervention: Drug: Estradiol Vaginal Cream, USP, 0.01%
Estradiol Vaginal Cream: Estradiol Vaginal Cream
|
Active Comparator: Estrace® Cream
n=216 participants at risk
Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days.
Intervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)
Estrace® Cream: Estrace® Cream
|
Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream
n=109 participants at risk
Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days.
Intervention: Drug: Placebo (Test vehicle cream) Vaginal Cream
Vehicle Cream: Vehicle Cream
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of Chronic Obstructive Pulmonary Disease
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • Number of events 1 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
Other adverse events
| Measure |
Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)
n=215 participants at risk
Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days.
Intervention: Drug: Estradiol Vaginal Cream, USP, 0.01%
Estradiol Vaginal Cream: Estradiol Vaginal Cream
|
Active Comparator: Estrace® Cream
n=216 participants at risk
Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days.
Intervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)
Estrace® Cream: Estrace® Cream
|
Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream
n=109 participants at risk
Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days.
Intervention: Drug: Placebo (Test vehicle cream) Vaginal Cream
Vehicle Cream: Vehicle Cream
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Gastrointestinal disorders
Abdominal distention
|
2.8%
6/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
2.3%
5/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
7/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
3.2%
7/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
1.8%
2/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
1.4%
3/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Gastrointestinal disorders
Constipation
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.93%
2/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Gastrointestinal disorders
Nausea
|
0.93%
2/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.93%
2/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Gastrointestinal disorders
Perianal erythema
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
1.8%
2/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
General disorders
Asthenia
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
General disorders
Pain
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Infections and infestations
Bronchitis
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Infections and infestations
Influenza
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Infections and infestations
Laryngitis
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Infections and infestations
Nasopharyngitis
|
0.93%
2/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.93%
2/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Infections and infestations
Otitis media
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Infections and infestations
Pharyngitis
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Infections and infestations
Rhinitis
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Infections and infestations
Sinusitis
|
0.93%
2/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Infections and infestations
Upper respiratory tract infection
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.93%
2/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Infections and infestations
Urinary tract infection
|
0.93%
2/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Infections and infestations
Vulvitis
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Infections and infestations
Vulvovaginal candidiasis
|
1.4%
3/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Injury, poisoning and procedural complications
Fall
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.93%
2/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Injury, poisoning and procedural complications
Post procedural hemorrhage
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.93%
2/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Investigations
Blood pressure diastolic increased
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Investigations
Smear vaginal abnormal
|
2.3%
5/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
1.4%
3/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.93%
2/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.93%
2/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.93%
2/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Nervous system disorders
Headache
|
2.8%
6/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
2.3%
5/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
2.8%
3/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
1.4%
3/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Nervous system disorders
Migraine
|
1.4%
3/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Nervous system disorders
Paraesthesia
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Nervous system disorders
Sinus headache
|
1.4%
3/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Nervous system disorders
Somnolence
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Nervous system disorders
Tension headache
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Psychiatric disorders
Irritability
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Renal and urinary disorders
Dysuria
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Renal and urinary disorders
Micturition urgency
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Adnexa uteri pain
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Breast discharge
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Breast tenderness
|
2.3%
5/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
2.8%
6/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Genital erosion
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Genital paresthesia
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Nipple pain
|
0.93%
2/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
1.9%
4/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.3%
7/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
2.3%
5/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
1.8%
2/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Uterine spasm
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Vaginal dysplasia
|
0.93%
2/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.93%
2/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Vulval edema
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
2.3%
5/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.93%
2/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.93%
2/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Vulvovaginal erythema
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.93%
2/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
2.8%
6/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
1.4%
3/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Reproductive system and breast disorders
Vulvovaginal swelling
|
0.93%
2/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.47%
1/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.93%
2/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Vascular disorders
Flushing
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.46%
1/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.00%
0/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
|
Vascular disorders
Hot flush
|
0.00%
0/215 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
2.3%
5/216 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
0.92%
1/109 • 8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place