Trial Outcomes & Findings for A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women (NCT NCT00630539)
NCT ID: NCT00630539
Last Updated: 2013-06-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
126 participants
Primary outcome timeframe
12 weeks
Results posted on
2013-06-28
Participant Flow
The study was conducted at 9 centers in Finland. First patient was enrolled on August 09, 2007 and last patient completed on February 11, 2008
The study population included postmenopausal women 40 to 80 years of age with a diagnosis of vulvar and vaginal atrophy (VVA) assessed by the maturation index (MI) of vaginal smear and vaginal pH at baseline
Participant milestones
| Measure |
Subjects on Placebo
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 5 mg/Day
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
29
|
30
|
|
Overall Study
COMPLETED
|
33
|
29
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
1
|
3
|
Reasons for withdrawal
| Measure |
Subjects on Placebo
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 5 mg/Day
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
Baseline Characteristics
A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Subjects on Placebo
n=34 Participants
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 5 mg/Day
n=33 Participants
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
n=29 Participants
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
n=30 Participants
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
62.8 years
STANDARD_DEVIATION 6.0 • n=99 Participants
|
61.5 years
STANDARD_DEVIATION 5.6 • n=107 Participants
|
63.4 years
STANDARD_DEVIATION 7.1 • n=206 Participants
|
62.0 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
62.4 years
STANDARD_DEVIATION 6.4 • n=31 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
126 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Participants
|
34 participants
n=99 Participants
|
33 participants
n=107 Participants
|
29 participants
n=206 Participants
|
30 participants
n=7 Participants
|
126 participants
n=31 Participants
|
|
Weight
|
69.6 kg
STANDARD_DEVIATION 10.1 • n=99 Participants
|
66.5 kg
STANDARD_DEVIATION 10.6 • n=107 Participants
|
68.7 kg
STANDARD_DEVIATION 13.5 • n=206 Participants
|
65.9 kg
STANDARD_DEVIATION 7.4 • n=7 Participants
|
67.7 kg
STANDARD_DEVIATION 10.4 • n=31 Participants
|
|
Height
|
1.609 m
STANDARD_DEVIATION 0.049 • n=99 Participants
|
1.636 m
STANDARD_DEVIATION .051 • n=107 Participants
|
1.641 m
STANDARD_DEVIATION .062 • n=206 Participants
|
1.617 m
STANDARD_DEVIATION .058 • n=7 Participants
|
1.626 m
STANDARD_DEVIATION 0.055 • n=31 Participants
|
|
BMI
|
26.89 kg/m^2
STANDARD_DEVIATION 3.95 • n=99 Participants
|
24.78 kg/m^2
STANDARD_DEVIATION 3.44 • n=107 Participants
|
25.50 kg/m^2
STANDARD_DEVIATION 4.99 • n=206 Participants
|
25.28 kg/m^2
STANDARD_DEVIATION 3.20 • n=7 Participants
|
25.61 kg/m^2
STANDARD_DEVIATION 3.90 • n=31 Participants
|
|
Alcohol
|
0.9 drinks/week
STANDARD_DEVIATION 1.9 • n=99 Participants
|
1.8 drinks/week
STANDARD_DEVIATION 2.4 • n=107 Participants
|
1.2 drinks/week
STANDARD_DEVIATION 1.7 • n=206 Participants
|
1.5 drinks/week
STANDARD_DEVIATION 2.3 • n=7 Participants
|
1.4 drinks/week
STANDARD_DEVIATION 2.1 • n=31 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: ITT
Outcome measures
| Measure |
Subjects on Placebo
n=34 Participants
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 5 mg/Day
n=33 Participants
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
n=29 Participants
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
n=30 Participants
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifine 15 mg/Day (Week 12)
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day (Week 12)
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
|
-3.0 percentage of parabasal cells
Standard Deviation 30.2
|
-2.8 percentage of parabasal cells
Standard Deviation 33.2
|
-24.1 percentage of parabasal cells
Standard Deviation 36.7
|
-26.8 percentage of parabasal cells
Standard Deviation 41.1
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: ITT
Outcome measures
| Measure |
Subjects on Placebo
n=34 Participants
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 5 mg/Day
n=33 Participants
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
n=29 Participants
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
n=30 Participants
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifine 15 mg/Day (Week 12)
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day (Week 12)
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear
|
0.2 percentage of superficial cells
Standard Deviation 1.5 • Interval -3.0 to 5.0
|
0.9 percentage of superficial cells
Standard Deviation 3.1 • Interval -4.0 to 11.0
|
5.0 percentage of superficial cells
Standard Deviation 9.1 • Interval -5.0 to 30.0
|
5.6 percentage of superficial cells
Standard Deviation 10.3 • Interval -5.0 to 35.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: ITT
Outcome measures
| Measure |
Subjects on Placebo
n=34 Participants
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 5 mg/Day
n=33 Participants
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
n=29 Participants
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
n=30 Participants
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifine 15 mg/Day (Week 12)
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day (Week 12)
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Vaginal pH
|
-0.07 pH
Standard Deviation 0.91
|
-0.37 pH
Standard Deviation 0.83
|
-0.95 pH
Standard Deviation 1.02
|
-1.11 pH
Standard Deviation 1.06
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening & Week 12Population: ITT
Outcome measures
| Measure |
Subjects on Placebo
n=34 Participants
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 5 mg/Day
n=34 Participants
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
n=33 Participants
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
n=33 Participants
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
n=29 Participants
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifine 15 mg/Day (Week 12)
n=29 Participants
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
n=30 Participants
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day (Week 12)
n=30 Participants
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Petechiae-Mild
|
47.1 percentage of subjects
|
29.4 percentage of subjects
|
42.4 percentage of subjects
|
39.4 percentage of subjects
|
55.2 percentage of subjects
|
24.1 percentage of subjects
|
53.3 percentage of subjects
|
30.0 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Petechiae-Moderate
|
26.5 percentage of subjects
|
26.5 percentage of subjects
|
12.1 percentage of subjects
|
6.1 percentage of subjects
|
31.0 percentage of subjects
|
17.2 percentage of subjects
|
26.7 percentage of subjects
|
3.3 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Petechiae-Severe
|
11.8 percentage of subjects
|
8.8 percentage of subjects
|
21.2 percentage of subjects
|
15.2 percentage of subjects
|
3.4 percentage of subjects
|
0.0 percentage of subjects
|
10.0 percentage of subjects
|
3.3 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Pallor-None
|
8.8 percentage of subjects
|
14.7 percentage of subjects
|
6.1 percentage of subjects
|
15.2 percentage of subjects
|
13.8 percentage of subjects
|
37.9 percentage of subjects
|
6.7 percentage of subjects
|
46.7 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Pallor-Mild
|
44.1 percentage of subjects
|
47.1 percentage of subjects
|
30.3 percentage of subjects
|
48.5 percentage of subjects
|
48.3 percentage of subjects
|
48.3 percentage of subjects
|
40.0 percentage of subjects
|
43.3 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Friability-Not done
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
3.0 percentage of subjects
|
0.0 percentage of subjects
|
3.4 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Vaginal dryness in the mucosa-None
|
8.8 percentage of subjects
|
23.5 percentage of subjects
|
6.1 percentage of subjects
|
27.3 percentage of subjects
|
10.3 percentage of subjects
|
51.7 percentage of subjects
|
10.0 percentage of subjects
|
73.3 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Vaginal dryness in the mucosa-Moderate
|
38.2 percentage of subjects
|
32.4 percentage of subjects
|
63.6 percentage of subjects
|
30.3 percentage of subjects
|
37.9 percentage of subjects
|
6.9 percentage of subjects
|
33.3 percentage of subjects
|
6.7 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Vaginal dryness in the mucosa-Severe
|
5.9 percentage of subjects
|
2.9 percentage of subjects
|
9.1 percentage of subjects
|
3.0 percentage of subjects
|
10.3 percentage of subjects
|
0.0 percentage of subjects
|
13.3 percentage of subjects
|
0.0 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Vaginal redness in the mucosa-Mild
|
52.9 percentage of subjects
|
41.2 percentage of subjects
|
33.3 percentage of subjects
|
21.2 percentage of subjects
|
48.3 percentage of subjects
|
27.6 percentage of subjects
|
50.0 percentage of subjects
|
40.0 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Vaginal redness in the mucosa-Moderate
|
26.5 percentage of subjects
|
26.5 percentage of subjects
|
33.3 percentage of subjects
|
21.2 percentage of subjects
|
31.0 percentage of subjects
|
17.2 percentage of subjects
|
23.3 percentage of subjects
|
0.0 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Vaginal redness in the mucosa-Severe
|
11.8 percentage of subjects
|
11.8 percentage of subjects
|
15.2 percentage of subjects
|
15.2 percentage of subjects
|
3.4 percentage of subjects
|
0.0 percentage of subjects
|
16.7 percentage of subjects
|
3.3 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Petechiae-None
|
14.7 percentage of subjects
|
35.3 percentage of subjects
|
24.2 percentage of subjects
|
36.4 percentage of subjects
|
10.3 percentage of subjects
|
55.2 percentage of subjects
|
10.0 percentage of subjects
|
60.0 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Petechiae-Not done
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
3.0 percentage of subjects
|
0.0 percentage of subjects
|
3.4 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Pallor-Moderate
|
41.2 percentage of subjects
|
35.3 percentage of subjects
|
57.6 percentage of subjects
|
30.3 percentage of subjects
|
31.0 percentage of subjects
|
10.3 percentage of subjects
|
43.3 percentage of subjects
|
6.7 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Pallor-Severe
|
5.9 percentage of subjects
|
2.9 percentage of subjects
|
6.1 percentage of subjects
|
3.0 percentage of subjects
|
6.9 percentage of subjects
|
0.0 percentage of subjects
|
10.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Pallor-Not done
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
3.0 percentage of subjects
|
0.0 percentage of subjects
|
3.4 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Friability-None
|
8.8 percentage of subjects
|
20.6 percentage of subjects
|
15.2 percentage of subjects
|
30.3 percentage of subjects
|
10.3 percentage of subjects
|
44.8 percentage of subjects
|
16.7 percentage of subjects
|
60.0 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Friability-Mild
|
41.2 percentage of subjects
|
32.4 percentage of subjects
|
27.3 percentage of subjects
|
30.3 percentage of subjects
|
34.5 percentage of subjects
|
44.8 percentage of subjects
|
40.0 percentage of subjects
|
33.3 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Friability-Moderate
|
38.2 percentage of subjects
|
41.2 percentage of subjects
|
36.4 percentage of subjects
|
33.3 percentage of subjects
|
48.3 percentage of subjects
|
6.9 percentage of subjects
|
23.3 percentage of subjects
|
3.3 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Friability-Severe
|
11.8 percentage of subjects
|
5.9 percentage of subjects
|
21.2 percentage of subjects
|
3.0 percentage of subjects
|
6.9 percentage of subjects
|
0.0 percentage of subjects
|
20.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Vaginal dryness in the mucosa-Mild
|
47.1 percentage of subjects
|
41.2 percentage of subjects
|
21.2 percentage of subjects
|
36.4 percentage of subjects
|
41.4 percentage of subjects
|
37.9 percentage of subjects
|
43.3 percentage of subjects
|
16.7 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Vaginal dryness in the mucosa-Not done
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
3.0 percentage of subjects
|
0.0 percentage of subjects
|
3.4 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Vaginal redness in the mucosa-None
|
8.8 percentage of subjects
|
20.6 percentage of subjects
|
18.2 percentage of subjects
|
39.4 percentage of subjects
|
17.2 percentage of subjects
|
51.7 percentage of subjects
|
10.0 percentage of subjects
|
53.3 percentage of subjects
|
|
Visual Evaluation of Vagina (by Gynecological Examination)
Vaginal redness in the mucosa-Not done
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
3.0 percentage of subjects
|
0.0 percentage of subjects
|
3.4 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 4Population: ITT
Outcome measures
| Measure |
Subjects on Placebo
n=34 Participants
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 5 mg/Day
n=33 Participants
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
n=29 Participants
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
n=30 Participants
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifine 15 mg/Day (Week 12)
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day (Week 12)
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Vaginal pH
|
-0.12 pH
Standard Deviation 0.59
|
-0.26 pH
Standard Deviation 0.68
|
-0.53 pH
Standard Deviation 0.83
|
-0.78 pH
Standard Deviation 1.00
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4Population: ITT
Outcome measures
| Measure |
Subjects on Placebo
n=34 Participants
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 5 mg/Day
n=33 Participants
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
n=29 Participants
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
n=30 Participants
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifine 15 mg/Day (Week 12)
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day (Week 12)
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index
|
0.6 percentage of superficial cells
Standard Deviation 2.7 • Interval -4.0 to 9.0
|
0.6 percentage of superficial cells
Standard Deviation 2.9 • Interval -4.0 to 11.0
|
2.5 percentage of superficial cells
Standard Deviation 5.6 • Interval -3.0 to 23.0
|
5.0 percentage of superficial cells
Standard Deviation 10.7 • Interval -4.0 to 55.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Outcome measures
| Measure |
Subjects on Placebo
n=34 Participants
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 5 mg/Day
n=33 Participants
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
n=29 Participants
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
n=30 Participants
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifine 15 mg/Day (Week 12)
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day (Week 12)
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Estradiol Levels
|
-0.004 nmol/L
Standard Deviation 0.011
|
0.004 nmol/L
Standard Deviation 0.015
|
-0.010 nmol/L
Standard Deviation 0.026
|
-0.003 nmol/L
Standard Deviation 0.008
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Outcome measures
| Measure |
Subjects on Placebo
n=34 Participants
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 5 mg/Day
n=33 Participants
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
n=29 Participants
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
n=30 Participants
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifine 15 mg/Day (Week 12)
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day (Week 12)
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Luteinizing Hormone Levels
|
-1.36 U/L
Standard Deviation 4.71
|
-2.89 U/L
Standard Deviation 5.94
|
-0.34 U/L
Standard Deviation 9.23
|
-3.78 U/L
Standard Deviation 7.34
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Outcome measures
| Measure |
Subjects on Placebo
n=34 Participants
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 5 mg/Day
n=33 Participants
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
n=29 Participants
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
n=30 Participants
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifine 15 mg/Day (Week 12)
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day (Week 12)
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Follicle Stimulating Hormone Levels
|
-10.36 U/L
Standard Deviation 20.41
|
-7.04 U/L
Standard Deviation 10.80
|
-5.99 U/L
Standard Deviation 23.07
|
-15.32 U/L
Standard Deviation 13.13
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Outcome measures
| Measure |
Subjects on Placebo
n=34 Participants
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 5 mg/Day
n=33 Participants
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
n=29 Participants
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
n=30 Participants
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifine 15 mg/Day (Week 12)
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day (Week 12)
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Sex Hormone Binding Globulin Levels
|
-2.4 nmol/L
Standard Deviation 10.0
|
2.9 nmol/L
Standard Deviation 12.2
|
6.3 nmol/L
Standard Deviation 12.5
|
18.0 nmol/L
Standard Deviation 20.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4Population: ITT
Outcome measures
| Measure |
Subjects on Placebo
n=34 Participants
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 5 mg/Day
n=33 Participants
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
n=29 Participants
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
n=30 Participants
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifine 15 mg/Day (Week 12)
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day (Week 12)
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index
|
-0.6 percentage of parabasal cells
Standard Deviation 24.1
|
-0.6 percentage of parabasal cells
Standard Deviation 23.8
|
-19.7 percentage of parabasal cells
Standard Deviation 27.0
|
-22.0 percentage of parabasal cells
Standard Deviation 42.7
|
—
|
—
|
—
|
—
|
Adverse Events
Subjects on Placebo
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Subjects on Ospemifene 5 mg/Day
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Subjects on Ospemifene 15 mg/Day
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Subjects on Ospemifene 30 mg/Day
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subjects on Placebo
n=34 participants at risk
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 5 mg/Day
n=33 participants at risk
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
n=29 participants at risk
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
n=30 participants at risk
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Ankle fracture
|
2.9%
1/34 • Throughout the study
|
0.00%
0/33 • Throughout the study
|
0.00%
0/29 • Throughout the study
|
0.00%
0/30 • Throughout the study
|
Other adverse events
| Measure |
Subjects on Placebo
n=34 participants at risk
Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 5 mg/Day
n=33 participants at risk
Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 15 mg/Day
n=29 participants at risk
Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
|
Subjects on Ospemifene 30 mg/Day
n=30 participants at risk
Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
|
|---|---|---|---|---|
|
Infections and infestations
Influenza
|
5.9%
2/34 • Throughout the study
|
0.00%
0/33 • Throughout the study
|
3.4%
1/29 • Throughout the study
|
6.7%
2/30 • Throughout the study
|
|
Infections and infestations
Respiratory tract infection
|
5.9%
2/34 • Throughout the study
|
0.00%
0/33 • Throughout the study
|
0.00%
0/29 • Throughout the study
|
0.00%
0/30 • Throughout the study
|
|
Infections and infestations
Urinary tract infection
|
5.9%
2/34 • Throughout the study
|
3.0%
1/33 • Throughout the study
|
0.00%
0/29 • Throughout the study
|
6.7%
2/30 • Throughout the study
|
|
Infections and infestations
Vaginitis bacterial
|
5.9%
2/34 • Throughout the study
|
0.00%
0/33 • Throughout the study
|
0.00%
0/29 • Throughout the study
|
0.00%
0/30 • Throughout the study
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
2/34 • Throughout the study
|
6.1%
2/33 • Throughout the study
|
0.00%
0/29 • Throughout the study
|
3.3%
1/30 • Throughout the study
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.9%
1/34 • Throughout the study
|
0.00%
0/33 • Throughout the study
|
0.00%
0/29 • Throughout the study
|
6.7%
2/30 • Throughout the study
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
5.9%
2/34 • Throughout the study
|
0.00%
0/33 • Throughout the study
|
0.00%
0/29 • Throughout the study
|
0.00%
0/30 • Throughout the study
|
|
Nervous system disorders
Dizziness
|
5.9%
2/34 • Throughout the study
|
0.00%
0/33 • Throughout the study
|
0.00%
0/29 • Throughout the study
|
6.7%
2/30 • Throughout the study
|
|
Nervous system disorders
Headache
|
2.9%
1/34 • Throughout the study
|
3.0%
1/33 • Throughout the study
|
17.2%
5/29 • Throughout the study
|
3.3%
1/30 • Throughout the study
|
|
Psychiatric disorders
Insomnia
|
5.9%
2/34 • Throughout the study
|
0.00%
0/33 • Throughout the study
|
3.4%
1/29 • Throughout the study
|
0.00%
0/30 • Throughout the study
|
|
Renal and urinary disorders
Dysuria
|
5.9%
2/34 • Throughout the study
|
0.00%
0/33 • Throughout the study
|
0.00%
0/29 • Throughout the study
|
0.00%
0/30 • Throughout the study
|
|
Reproductive system and breast disorders
Genital discharge
|
2.9%
1/34 • Throughout the study
|
0.00%
0/33 • Throughout the study
|
6.9%
2/29 • Throughout the study
|
3.3%
1/30 • Throughout the study
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/34 • Throughout the study
|
0.00%
0/33 • Throughout the study
|
0.00%
0/29 • Throughout the study
|
6.7%
2/30 • Throughout the study
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
5.9%
2/34 • Throughout the study
|
0.00%
0/33 • Throughout the study
|
3.4%
1/29 • Throughout the study
|
0.00%
0/30 • Throughout the study
|
|
Vascular disorders
Hot flush
|
5.9%
2/34 • Throughout the study
|
9.1%
3/33 • Throughout the study
|
10.3%
3/29 • Throughout the study
|
10.0%
3/30 • Throughout the study
|
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