Trial Outcomes & Findings for A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women (NCT NCT00276094)
NCT ID: NCT00276094
Last Updated: 2013-06-28
Results Overview
This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
826 participants
Primary outcome timeframe
Baseline (Randomization) to Week 12
Results posted on
2013-06-28
Participant Flow
Participant milestones
| Measure |
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Placebo Tablets and Nonhormonal Vaginal Lubricant
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Overall Study
STARTED
|
282
|
276
|
268
|
|
Overall Study
COMPLETED
|
225
|
234
|
230
|
|
Overall Study
NOT COMPLETED
|
57
|
42
|
38
|
Reasons for withdrawal
| Measure |
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Placebo Tablets and Nonhormonal Vaginal Lubricant
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
15
|
13
|
11
|
|
Overall Study
Withdrawal by Subject
|
14
|
14
|
12
|
|
Overall Study
Protocol Violation
|
16
|
7
|
10
|
|
Overall Study
Lost to Follow-up
|
8
|
6
|
4
|
|
Overall Study
Other-Subject moved out of country
|
1
|
0
|
0
|
|
Overall Study
Other-Scheduled gastroplasty
|
1
|
0
|
0
|
|
Overall Study
Other-Lack of efficacy
|
1
|
0
|
0
|
|
Overall Study
Other-Refused follow-up visit
|
1
|
0
|
0
|
|
Overall Study
Other-Repeat safety labs-exclusionary
|
0
|
1
|
0
|
|
Overall Study
Other-Relocation
|
0
|
1
|
0
|
|
Overall Study
Other-Study medication lost
|
0
|
0
|
1
|
Baseline Characteristics
A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
n=282 Participants
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
n=276 Participants
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Placebo Tablets and Nonhormonal Vaginal Lubricant
n=268 Participants
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Total
n=826 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
58.4 Years
STANDARD_DEVIATION 6.27 • n=5 Participants
|
58.6 Years
STANDARD_DEVIATION 6.34 • n=7 Participants
|
58.9 Years
STANDARD_DEVIATION 6.09 • n=5 Participants
|
58.6 Years
STANDARD_DEVIATION 6.23 • n=4 Participants
|
|
Sex: Female, Male
Female
|
282 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
826 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
253 Participants
n=5 Participants
|
249 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
744 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Missing value
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
265 Participants
n=5 Participants
|
256 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
765 Participants
n=4 Participants
|
|
Height
|
161.9 cm
STANDARD_DEVIATION 6.60 • n=5 Participants
|
162.1 cm
STANDARD_DEVIATION 6.42 • n=7 Participants
|
162.3 cm
STANDARD_DEVIATION 6.87 • n=5 Participants
|
162.1 cm
STANDARD_DEVIATION 6.62 • n=4 Participants
|
|
Weight
|
69.2 kg
STANDARD_DEVIATION 13.06 • n=5 Participants
|
68.4 kg
STANDARD_DEVIATION 12.08 • n=7 Participants
|
69.0 kg
STANDARD_DEVIATION 12.90 • n=5 Participants
|
68.9 kg
STANDARD_DEVIATION 12.68 • n=4 Participants
|
|
Body Mass Index (BMI)
|
26.4 kg/m^2
STANDARD_DEVIATION 4.51 • n=5 Participants
|
26.0 kg/m^2
STANDARD_DEVIATION 4.44 • n=7 Participants
|
26.1 kg/m^2
STANDARD_DEVIATION 4.37 • n=5 Participants
|
26.2 kg/m^2
STANDARD_DEVIATION 4.43 • n=4 Participants
|
|
Intact Uterus?
Yes
|
129 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
379 Participants
n=4 Participants
|
|
Intact Uterus?
No
|
153 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
447 Participants
n=4 Participants
|
|
Intact Cervix?
Yes
|
133 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
395 Participants
n=4 Participants
|
|
Intact Cervix?
No
|
149 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
431 Participants
n=4 Participants
|
|
Number (No.) of Pregnancies
|
2.61 Pregnancies per participant
STANDARD_DEVIATION 1.834 • n=5 Participants
|
2.39 Pregnancies per participant
STANDARD_DEVIATION 1.638 • n=7 Participants
|
2.38 Pregnancies per participant
STANDARD_DEVIATION 1.525 • n=5 Participants
|
2.46 Pregnancies per participant
STANDARD_DEVIATION 1.675 • n=4 Participants
|
|
No. of Vaginal Births
|
1.78 Vaginal births per participant
STANDARD_DEVIATION 1.565 • n=5 Participants
|
1.65 Vaginal births per participant
STANDARD_DEVIATION 1.478 • n=7 Participants
|
1.59 Vaginal births per participant
STANDARD_DEVIATION 1.386 • n=5 Participants
|
1.68 Vaginal births per participant
STANDARD_DEVIATION 1.480 • n=4 Participants
|
|
No. of Urinary Tract Infections in Past 6 Months
Missing values
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
No. of Urinary Tract Infections in Past 6 Months
0
|
247 Participants
n=5 Participants
|
239 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
728 Participants
n=4 Participants
|
|
No. of Urinary Tract Infections in Past 6 Months
1
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
No. of Urinary Tract Infections in Past 6 Months
2
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
No. of Urinary Tract Infections in Past 6 Months
3
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
No. of Urinary Tract Infections in Past 6 Months
4 or more
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Currently Experiencing Hot Flashes?
No
|
110 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
325 Participants
n=4 Participants
|
|
Currently Experiencing Hot Flashes?
Yes
|
172 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
501 Participants
n=4 Participants
|
|
No. of Days with Hot Flashes (/month)
|
19.7 Days
STANDARD_DEVIATION 11.68 • n=5 Participants
|
19.6 Days
STANDARD_DEVIATION 11.49 • n=7 Participants
|
19.6 Days
STANDARD_DEVIATION 11.09 • n=5 Participants
|
19.6 Days
STANDARD_DEVIATION 11.41 • n=4 Participants
|
|
Previous Hormone Treatment
No
|
232 Partcipants
n=5 Participants
|
222 Partcipants
n=7 Participants
|
218 Partcipants
n=5 Participants
|
672 Partcipants
n=4 Participants
|
|
Previous Hormone Treatment
Yes
|
50 Partcipants
n=5 Participants
|
54 Partcipants
n=7 Participants
|
50 Partcipants
n=5 Participants
|
154 Partcipants
n=4 Participants
|
|
Percentage of Parabasal Cells at Screening
|
40.1 Percentage of Parabasal Cells
STANDARD_DEVIATION 38.33 • n=5 Participants
|
39.3 Percentage of Parabasal Cells
STANDARD_DEVIATION 38.98 • n=7 Participants
|
38.5 Percentage of Parabasal Cells
STANDARD_DEVIATION 37.60 • n=5 Participants
|
39.3 Percentage of Parabasal Cells
STANDARD_DEVIATION 38.28 • n=4 Participants
|
|
Percentage of Superficial Cells at Screening
|
1.25 Percentage of Superficial Cells
STANDARD_DEVIATION 2.907 • n=5 Participants
|
1.04 Percentage of Superficial Cells
STANDARD_DEVIATION 3.368 • n=7 Participants
|
0.91 Percentage of Superficial Cells
STANDARD_DEVIATION 2.635 • n=5 Participants
|
1.07 Percentage of Superficial Cells
STANDARD_DEVIATION 2.989 • n=4 Participants
|
|
Vaginal pH at Screening
|
6.35 Vaginal pH
STANDARD_DEVIATION 0.736 • n=5 Participants
|
6.37 Vaginal pH
STANDARD_DEVIATION 0.763 • n=7 Participants
|
6.34 Vaginal pH
STANDARD_DEVIATION 0.732 • n=5 Participants
|
6.35 Vaginal pH
STANDARD_DEVIATION 0.743 • n=4 Participants
|
|
Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) by Severity (Overall [Composite])
None
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) by Severity (Overall [Composite])
Mild
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) by Severity (Overall [Composite])
Moderate
|
121 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
351 Participants
n=4 Participants
|
|
Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) by Severity (Overall [Composite])
Severe
|
148 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
434 Participants
n=4 Participants
|
|
MBS-Vaginal Dryness at Randomization
Mild
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
MBS-Vaginal Dryness at Randomization
Moderate
|
47 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
170 Participants
n=4 Participants
|
|
MBS-Vaginal Dryness at Randomization
Severe
|
52 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
|
MBS-Vaginal Pain with Sexual Activity at Randomization
None
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
MBS-Vaginal Pain with Sexual Activity at Randomization
Mild
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
MBS-Vaginal Pain with Sexual Activity at Randomization
Moderate
|
46 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
MBS-Vaginal Pain with Sexual Activity at Randomization
Severe
|
84 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
254 Participants
n=4 Participants
|
|
MBS-Vaginal and/or Vulvar Irritation or Itching at Randomization
None
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
MBS-Vaginal and/or Vulvar Irritation or Itching at Randomization
Mild
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
MBS-Vaginal and/or Vulvar Irritation or Itching at Randomization
Moderate
|
25 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
MBS-Vaginal and/or Vulvar Irritation or Itching at Randomization
Severe
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
MBS-Difficult/Painful Urination at Randomization
Moderate
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
MBS-Difficult/Painful Urination at Randomization
Severe
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
MBS-Vaginal Bleeding with Sexual Activity at Randomization
None
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
MBS-Vaginal Bleeding with Sexual Activity at Randomization
Moderate
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
MBS-Vaginal Bleeding with Sexual Activity at Randomization
Severe
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Randomization) to Week 12This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Outcome measures
| Measure |
Placebo Tablets and Nonhormonal Vaginal Lubricant
n=104 Participants
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
n=102 Participants
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
n=118 Participants
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness
|
-0.84 Units on a scale
Standard Deviation 0.996
|
-1.22 Units on a scale
Standard Deviation 0.929
|
-1.26 Units on a scale
Standard Deviation 1.025
|
PRIMARY outcome
Timeframe: Baseline (Randomization) to Week 12This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Outcome measures
| Measure |
Placebo Tablets and Nonhormonal Vaginal Lubricant
n=122 Participants
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
n=136 Participants
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
n=120 Participants
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity
|
-0.89 Units on a scale
Standard Deviation 1.115
|
-1.02 Units on a scale
Standard Deviation 1.132
|
-1.19 Units on a scale
Standard Deviation 1.292
|
PRIMARY outcome
Timeframe: Baseline (Screening) to Week 12Outcome measures
| Measure |
Placebo Tablets and Nonhormonal Vaginal Lubricant
n=268 Participants
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
n=282 Participants
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
n=276 Participants
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Mean Change From Baseline in Vaginal pH
|
-0.096 pH
Standard Deviation 0.8357
|
-0.67 pH
Standard Deviation 1.054
|
-1.01 pH
Standard Deviation 1.053
|
PRIMARY outcome
Timeframe: Baseline (Screening) to Week 12Outcome measures
| Measure |
Placebo Tablets and Nonhormonal Vaginal Lubricant
n=268 Participants
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
n=280 Participants
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
n=276 Participants
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear
|
3.98 percentage of parabasal cells
Standard Deviation 35.205
|
-21.9 percentage of parabasal cells
Standard Deviation 32.60
|
-30.1 percentage of parabasal cells
Standard Deviation 37.93
|
PRIMARY outcome
Timeframe: Baseline (Screening) to Week 12Outcome measures
| Measure |
Placebo Tablets and Nonhormonal Vaginal Lubricant
n=268 Participants
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
n=280 Participants
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
n=276 Participants
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear
|
2.18 percentage of superficial cells
Standard Deviation 8.393
|
7.78 percentage of superficial cells
Standard Deviation 12.136
|
10.8 percentage of superficial cells
Standard Deviation 15.66
|
SECONDARY outcome
Timeframe: Baseline (Screening) to Week 12Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Outcome measures
| Measure |
Placebo Tablets and Nonhormonal Vaginal Lubricant
n=215 Participants
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
n=230 Participants
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
n=223 Participants
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Change From Baseline in Visual Evaluation of the Vagina
Petechiae
|
-0.037 Units on a scale
Standard Deviation 0.8080
|
-0.50 Units on a scale
Standard Deviation 0.829
|
-0.60 Units on a scale
Standard Deviation 0.848
|
|
Change From Baseline in Visual Evaluation of the Vagina
Pallor
|
-0.30 Units on a scale
Standard Deviation 0.940
|
-0.75 Units on a scale
Standard Deviation 0.914
|
-0.93 Units on a scale
Standard Deviation 0.930
|
|
Change From Baseline in Visual Evaluation of the Vagina
Friability
|
-0.16 Units on a scale
Standard Deviation 0.818
|
-0.57 Units on a scale
Standard Deviation 0.922
|
-0.71 Units on a scale
Standard Deviation 0.911
|
|
Change From Baseline in Visual Evaluation of the Vagina
Vaginal dryness in mucosa
|
-0.48 Units on a scale
Standard Deviation 0.911
|
-1.05 Units on a scale
Standard Deviation 0.959
|
-1.22 Units on a scale
Standard Deviation 0.981
|
|
Change From Baseline in Visual Evaluation of the Vagina
Vaginal redness in mucosa
|
-0.23 Units on a scale
Standard Deviation 0.792
|
-0.44 Units on a scale
Standard Deviation 0.811
|
-0.60 Units on a scale
Standard Deviation 0.924
|
SECONDARY outcome
Timeframe: Baseline (Randomization) to Week 12This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Outcome measures
| Measure |
Placebo Tablets and Nonhormonal Vaginal Lubricant
n=268 Participants
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
n=282 Participants
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
n=276 Participants
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Change From Baseline in Severity of VVA Symptoms
Vaginal dryness
|
-0.63 Units on a scale
Standard Deviation 1.047
|
-0.96 Units on a scale
Standard Deviation 1.018
|
-1.17 Units on a scale
Standard Deviation 1.050
|
|
Change From Baseline in Severity of VVA Symptoms
Vaginal pain associated with sexual activity
|
-0.57 Units on a scale
Standard Deviation 1.224
|
-0.77 Units on a scale
Standard Deviation 1.200
|
-0.87 Units on a scale
Standard Deviation 1.278
|
|
Change From Baseline in Severity of VVA Symptoms
Vulvar/vaginal itching or irritation
|
-0.44 Units on a scale
Standard Deviation 0.948
|
-0.40 Units on a scale
Standard Deviation 1.080
|
-0.58 Units on a scale
Standard Deviation 0.982
|
|
Change From Baseline in Severity of VVA Symptoms
Difficult/painful urination
|
-0.097 Units on a scale
Standard Deviation 0.6745
|
-0.17 Units on a scale
Standard Deviation 0.676
|
-0.20 Units on a scale
Standard Deviation 0.673
|
|
Change From Baseline in Severity of VVA Symptoms
Vaginal bleeding associated with sexual activity
|
-0.12 Units on a scale
Standard Deviation 0.667
|
-0.26 Units on a scale
Standard Deviation 0.807
|
-0.23 Units on a scale
Standard Deviation 0.707
|
SECONDARY outcome
Timeframe: Baseline (Screening) to Week 12Population: Analysis populations for each hormone: Ospemifene(30 mg): E2-231, FSH-232, LH-231, SHBG-232, Testosterone(free)-183, Testosterone(total)-183 Ospemifene(60 mg): E2-221, FSH-222, LH-222, SHBG-221, Testosterone(free)-175, Testosterone(total)-176 Placebo: E2-216, FSH-216, LH-216, SHBG-216, Testosterone(free)-178, Testosterone(total)-178
Outcome measures
| Measure |
Placebo Tablets and Nonhormonal Vaginal Lubricant
n=216 Participants
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
n=232 Participants
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
n=222 Participants
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Change From Baseline in Estradiol Levels
|
0.30 pg/mL
Standard Deviation 3.90
|
-1.44 pg/mL
Standard Deviation 19.01
|
1.02 pg/mL
Standard Deviation 12.74
|
SECONDARY outcome
Timeframe: Baseline (Screening) to Week 12Outcome measures
| Measure |
Placebo Tablets and Nonhormonal Vaginal Lubricant
n=216 Participants
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
n=232 Participants
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
n=222 Participants
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Change From Baseline in Follicle Stimulating Hormone Levels
|
-1.33 IU/L
Standard Deviation 10.87
|
-5.93 IU/L
Standard Deviation 12.49
|
-8.71 IU/L
Standard Deviation 13.61
|
SECONDARY outcome
Timeframe: Baseline (Screening) to Week 12Outcome measures
| Measure |
Placebo Tablets and Nonhormonal Vaginal Lubricant
n=216 Participants
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
n=232 Participants
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
n=222 Participants
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Change From Baseline in Luteinizing Hormone Levels
|
0.41 IU/L
Standard Deviation 7.25
|
-2.85 IU/L
Standard Deviation 6.07
|
-3.73 IU/L
Standard Deviation 5.83
|
SECONDARY outcome
Timeframe: Baseline (Screening) to Week 12Outcome measures
| Measure |
Placebo Tablets and Nonhormonal Vaginal Lubricant
n=216 Participants
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
n=232 Participants
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
n=222 Participants
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Change From Baseline in Sex Hormone Binding Globulin Levels
|
-2.17 nmol/L
Standard Deviation 12.02
|
11.1 nmol/L
Standard Deviation 16.46
|
22.8 nmol/L
Standard Deviation 22.06
|
SECONDARY outcome
Timeframe: Baseline (Screening) to Week 12Outcome measures
| Measure |
Placebo Tablets and Nonhormonal Vaginal Lubricant
n=216 Participants
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
n=232 Participants
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
n=222 Participants
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Change From Baseline in Testosterone (Free) Levels
|
-0.008 ng/dL
Standard Deviation 0.13
|
0.002 ng/dL
Standard Deviation 0.51
|
-0.031 ng/dL
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Baseline (Screening) to Week 12Outcome measures
| Measure |
Placebo Tablets and Nonhormonal Vaginal Lubricant
n=216 Participants
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
n=232 Participants
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
n=222 Participants
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Change From Baseline in Testosterone (Total) Levels
|
-0.059 ng/dL
Standard Deviation 6.07
|
1.55 ng/dL
Standard Deviation 18.82
|
1.92 ng/dL
Standard Deviation 5.56
|
SECONDARY outcome
Timeframe: Baseline (Randomization) to Week 12Outcome measures
| Measure |
Placebo Tablets and Nonhormonal Vaginal Lubricant
n=216 Participants
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
n=229 Participants
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
n=223 Participants
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Change From Baseline in Urinary Symptoms
Difficulty emptying bladder-Worsened
|
15 Participants
|
14 Participants
|
11 Participants
|
|
Change From Baseline in Urinary Symptoms
Frequent urination-Improved
|
60 Participants
|
49 Participants
|
63 Participants
|
|
Change From Baseline in Urinary Symptoms
Frequent urination-Worsened
|
22 Participants
|
24 Participants
|
25 Participants
|
|
Change From Baseline in Urinary Symptoms
Urine leakage (feeling of urgency)-Improved
|
57 Participants
|
52 Participants
|
53 Participants
|
|
Change From Baseline in Urinary Symptoms
Urine leakage (feeling of urgency)-Worsened
|
32 Participants
|
24 Participants
|
26 Participants
|
|
Change From Baseline in Urinary Symptoms
Urine leakage with physical exertion-Improved
|
47 Participants
|
50 Participants
|
56 Participants
|
|
Change From Baseline in Urinary Symptoms
Urine leakage with physical exertion-Worsened
|
27 Participants
|
24 Participants
|
23 Participants
|
|
Change From Baseline in Urinary Symptoms
Small amount of urine leakage-Improved
|
58 Participants
|
59 Participants
|
55 Participants
|
|
Change From Baseline in Urinary Symptoms
Small amount of urine leakage-Worsened
|
27 Participants
|
30 Participants
|
32 Participants
|
|
Change From Baseline in Urinary Symptoms
Difficulty emptying bladder-Improved
|
24 Participants
|
25 Participants
|
26 Participants
|
|
Change From Baseline in Urinary Symptoms
Pain in lower abdominal/genital area-Improved
|
37 Participants
|
37 Participants
|
41 Participants
|
|
Change From Baseline in Urinary Symptoms
Pain in lower abdominal or genital area-Worsened
|
16 Participants
|
17 Participants
|
13 Participants
|
Adverse Events
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
Serious events: 5 serious events
Other events: 99 other events
Deaths: 0 deaths
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
Serious events: 0 serious events
Other events: 99 other events
Deaths: 0 deaths
Placebo Tablets and Nonhormonal Vaginal Lubricant
Serious events: 4 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
n=282 participants at risk
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
n=276 participants at risk
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Placebo Tablets and Nonhormonal Vaginal Lubricant
n=268 participants at risk
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.35%
1/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.37%
1/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Gastrointestinal disorders
Duodenal Stenosis
|
0.35%
1/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Gastrointestinal disorders
Duodenitis
|
0.35%
1/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.37%
1/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Investigations
Red Blood Cell Sedimentation Rate Increased
|
0.00%
0/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.37%
1/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.35%
1/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.37%
1/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Metastatic
|
0.35%
1/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.35%
1/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.37%
1/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.37%
1/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.37%
1/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.37%
1/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Surgical and medical procedures
Gastric Bypass
|
0.35%
1/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.00%
0/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
Other adverse events
| Measure |
Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant
n=282 participants at risk
Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant
n=276 participants at risk
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
Placebo Tablets and Nonhormonal Vaginal Lubricant
n=268 participants at risk
Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
|
|---|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
7.1%
20/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
7.2%
20/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
3.0%
8/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Infections and infestations
Fungal Infection
|
2.5%
7/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
3.3%
9/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.37%
1/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Infections and infestations
Sinusitis
|
2.1%
6/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
2.5%
7/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
3.7%
10/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
1.1%
3/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
4.0%
11/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.75%
2/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Nervous system disorders
Headache
|
6.0%
17/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
2.5%
7/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
5.2%
14/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.5%
7/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
4.0%
11/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
1.5%
4/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
4.3%
12/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
4.0%
11/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
0.37%
1/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
|
Vascular disorders
Hot Flush
|
9.6%
27/282 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
8.3%
23/276 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
3.4%
9/268 • 16 weeks (Visit 2 [Randomization] to Visit 5)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER