Trial Outcomes & Findings for Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus (NCT NCT01585558)
NCT ID: NCT01585558
Last Updated: 2018-05-21
Results Overview
COMPLETED
PHASE3
180 participants
Week 20 (Phone Contact) to Week 56 (Visit 7)
2018-05-21
Participant Flow
Participant milestones
| Measure |
Ospemifene 30 mg (Dose 1)
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
62
|
69
|
49
|
|
Overall Study
COMPLETED
|
49
|
57
|
34
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
15
|
Reasons for withdrawal
| Measure |
Ospemifene 30 mg (Dose 1)
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
8
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
3
|
|
Overall Study
Adverse Event
|
3
|
4
|
1
|
|
Overall Study
Protocol Violation
|
4
|
3
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
Baseline Characteristics
Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus
Baseline characteristics by cohort
| Measure |
Ospemifene 30 mg (Dose 1)
n=62 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=69 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=49 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.4 Years
STANDARD_DEVIATION 6.13 • n=5 Participants
|
57.7 Years
STANDARD_DEVIATION 5.88 • n=7 Participants
|
58.2 Years
STANDARD_DEVIATION 4.02 • n=5 Participants
|
58.1 Years
STANDARD_DEVIATION 5.51 • n=4 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
180 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
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
174 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
58 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
162 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 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
|
|
Height
|
162.83 cm
STANDARD_DEVIATION 6.930 • n=5 Participants
|
162.53 cm
STANDARD_DEVIATION 6.488 • n=7 Participants
|
163.27 cm
STANDARD_DEVIATION 6.082 • n=5 Participants
|
162.84 cm
STANDARD_DEVIATION 6.509 • n=4 Participants
|
|
Weight
|
68.92 kg
STANDARD_DEVIATION 11.316 • n=5 Participants
|
65.52 kg
STANDARD_DEVIATION 11.626 • n=7 Participants
|
66.71 kg
STANDARD_DEVIATION 10.482 • n=5 Participants
|
67.02 kg
STANDARD_DEVIATION 11.252 • n=4 Participants
|
|
Body mass index (BMI)
|
26.014 kg/m^2
STANDARD_DEVIATION 4.1507 • n=5 Participants
|
24.792 kg/m^2
STANDARD_DEVIATION 4.1292 • n=7 Participants
|
25.045 kg/m^2
STANDARD_DEVIATION 3.8496 • n=5 Participants
|
25.282 kg/m^2
STANDARD_DEVIATION 4.0762 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 20 (Phone Contact) to Week 56 (Visit 7)Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=62 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=69 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=49 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Incidence of Adverse Events (AEs)
Serious AE
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Incidence of Adverse Events (AEs)
Treatment-Emergent AE
|
38 Participants
|
44 Participants
|
22 Participants
|
|
Incidence of Adverse Events (AEs)
Related AE (Possibly/Probably/Definitely Related)
|
11 Participants
|
18 Participants
|
5 Participants
|
|
Incidence of Adverse Events (AEs)
AE Causing Study Drug Discontinuation
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Incidence of Adverse Events (AEs)
Severe AE
|
6 Participants
|
7 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 34 out of 49 subjects in the placebo group were analyzed.
Cervical Pap smear samples were used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=34 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Assessment of Cervical Pap Smear Samples
ASC-US
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Assessment of Cervical Pap Smear Samples
Inadequate squamous epithelial component
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Assessment of Cervical Pap Smear Samples
Low grade SIL (slight dysplasia and/or HPV effect)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Assessment of Cervical Pap Smear Samples
Negative for intraepithelial lesion or malignancy
|
45 Participants
|
54 Participants
|
33 Participants
|
|
Assessment of Cervical Pap Smear Samples
Reactive endocervical and/or metaplastic cells
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Assessment of Cervical Pap Smear Samples
Unsatisfactory: Due to reasons noted
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 46 out of 62 subjects in the ospemifene 30 mg group, 55 out of 69 subjects in the ospemifene 60 mg group, and 32 out of 49 subjects in the placebo group were analyzed.
Assessments were based on Blaustein's classification.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=46 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=55 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=32 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Assessment of Endometrial Biopsy
Weakly proliferative
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Assessment of Endometrial Biopsy
Atypical epithelial proliferation
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Assessment of Endometrial Biopsy
Proliferative pattern, disordered type
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Assessment of Endometrial Biopsy
Atrophic/inactive/insufficient
|
44 Participants
|
53 Participants
|
32 Participants
|
|
Assessment of Endometrial Biopsy
Other (Polyp, atrophic type)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Assessment of Endometrial Biopsy
Hyperplasia or carcinoma
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=62 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=69 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=49 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Mean Percent Change From Baseline in Serum Lipids
Total Cholesterol
|
-0.14 percent change
Standard Deviation 14.807
|
2.35 percent change
Standard Deviation 13.663
|
6.24 percent change
Standard Deviation 12.904
|
|
Mean Percent Change From Baseline in Serum Lipids
Low-density-lipoprotein cholesterol (LDL-C)
|
-0.02 percent change
Standard Deviation 19.462
|
2.42 percent change
Standard Deviation 19.107
|
10.38 percent change
Standard Deviation 19.776
|
|
Mean Percent Change From Baseline in Serum Lipids
High-density-lipoprotein cholesterol (HDL-C)
|
6.48 percent change
Standard Deviation 13.881
|
5.76 percent change
Standard Deviation 12.686
|
2.39 percent change
Standard Deviation 14.026
|
|
Mean Percent Change From Baseline in Serum Lipids
Triglycerides
|
-0.66 percent change
Standard Deviation 28.864
|
5.12 percent change
Standard Deviation 31.076
|
20.36 percent change
Standard Deviation 41.755
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=62 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=69 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=49 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Mean Percent Change From Baseline in Serum Lipids
Total Cholesterol
|
-0.55 percent change
Standard Deviation 13.910
|
-2.45 percent change
Standard Deviation 12.323
|
-1.05 percent change
Standard Deviation 9.289
|
|
Mean Percent Change From Baseline in Serum Lipids
LDL-C
|
-0.87 percent change
Standard Deviation 19.748
|
-6.20 percent change
Standard Deviation 18.623
|
-0.42 percent change
Standard Deviation 15.418
|
|
Mean Percent Change From Baseline in Serum Lipids
HDL-C
|
6.07 percent change
Standard Deviation 16.836
|
1.29 percent change
Standard Deviation 12.787
|
-4.41 percent change
Standard Deviation 14.347
|
|
Mean Percent Change From Baseline in Serum Lipids
Triglycerides
|
-3.10 percent change
Standard Deviation 32.749
|
15.19 percent change
Standard Deviation 35.789
|
21.57 percent change
Standard Deviation 40.802
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=62 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=69 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=49 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Mean Change in Blood Chemistry Parameters
Alanine Aminotransferase (ALT)
|
-1.2 U/L
Standard Deviation 9.39
|
-1.3 U/L
Standard Deviation 8.73
|
-1.3 U/L
Standard Deviation 8.22
|
|
Mean Change in Blood Chemistry Parameters
Aspartate Aminotransferase (AST)
|
0.8 U/L
Standard Deviation 4.67
|
1.2 U/L
Standard Deviation 5.43
|
0.5 U/L
Standard Deviation 4.59
|
|
Mean Change in Blood Chemistry Parameters
Creatine Kinase (CK)
|
1.1 U/L
Standard Deviation 50.97
|
-4.4 U/L
Standard Deviation 48.78
|
18.7 U/L
Standard Deviation 69.50
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=62 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=69 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=49 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Mean Change in Blood Chemistry Parameters
ALT
|
-2.1 U/L
Standard Deviation 10.27
|
-3.2 U/L
Standard Deviation 7.91
|
-2.2 U/L
Standard Deviation 7.21
|
|
Mean Change in Blood Chemistry Parameters
AST
|
1.5 U/L
Standard Deviation 4.99
|
0.5 U/L
Standard Deviation 5.03
|
0.3 U/L
Standard Deviation 4.95
|
|
Mean Change in Blood Chemistry Parameters
CK
|
7.3 U/L
Standard Deviation 62.70
|
1.2 U/L
Standard Deviation 56.78
|
-6.0 U/L
Standard Deviation 31.82
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 50 out of 62 subjects in the ospemifene 30 mg group, 60 out of 69 subjects in the ospemifene 60 mg group, and 37 out of 49 subjects in the placebo group were analyzed.
Mean change in endometrial thickness from baseline
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=50 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=60 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=37 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)
|
0.580 mm
Standard Deviation 1.9041
|
0.818 mm
Standard Deviation 1.6689
|
-0.119 mm
Standard Deviation 1.1629
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 46 out of 62 subjects in the ospemifene 30 mg group, 52 out of 69 subjects in the ospemifene 60 mg group, and 30 out of 49 subjects in the placebo group were analyzed.
Mean change in endometrial thickness from baseline
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=46 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=52 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=30 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Assessment of Endometrial Safety With a TVU
|
0.681 mm
Standard Deviation 2.5666
|
1.139 mm
Standard Deviation 1.5568
|
-0.041 mm
Standard Deviation 1.1455
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 65 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=65 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Visual Evaluation of the Vagina
Petechiae
|
-0.7 Units on a scale
Standard Deviation 0.94
|
-0.6 Units on a scale
Standard Deviation 0.82
|
-0.3 Units on a scale
Standard Deviation 0.79
|
|
Change From Baseline in Visual Evaluation of the Vagina
Pallor
|
-1.3 Units on a scale
Standard Deviation 0.89
|
-1.2 Units on a scale
Standard Deviation 1.02
|
-0.5 Units on a scale
Standard Deviation 0.94
|
|
Change From Baseline in Visual Evaluation of the Vagina
Friability
|
-0.9 Units on a scale
Standard Deviation 1.02
|
-0.8 Units on a scale
Standard Deviation 0.95
|
-0.6 Units on a scale
Standard Deviation 0.99
|
|
Change From Baseline in Visual Evaluation of the Vagina
Vaginal Dryness in Mucosa
|
-1.6 Units on a scale
Standard Deviation 1.07
|
-1.4 Units on a scale
Standard Deviation 0.91
|
-0.8 Units on a scale
Standard Deviation 1.11
|
|
Change From Baseline in Visual Evaluation of the Vagina
Vaginal Redness in Mucosa
|
-0.8 Units on a scale
Standard Deviation 0.96
|
-0.7 Units on a scale
Standard Deviation 0.95
|
-0.4 Units on a scale
Standard Deviation 0.89
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Visual Evaluation of the Vagina
Petechiae
|
-0.8 Units on a scale
Standard Deviation 0.85
|
-0.7 Units on a scale
Standard Deviation 0.91
|
-0.4 Units on a scale
Standard Deviation 0.73
|
|
Change From Baseline in Visual Evaluation of the Vagina
Pallor
|
-1.3 Units on a scale
Standard Deviation 0.74
|
-1.2 Units on a scale
Standard Deviation 1.15
|
-0.6 Units on a scale
Standard Deviation 1.03
|
|
Change From Baseline in Visual Evaluation of the Vagina
Friability
|
-0.9 Units on a scale
Standard Deviation 0.91
|
-0.7 Units on a scale
Standard Deviation 0.95
|
-0.5 Units on a scale
Standard Deviation 0.92
|
|
Change From Baseline in Visual Evaluation of the Vagina
Vaginal Dryness in Mucosa
|
-1.7 Units on a scale
Standard Deviation 0.96
|
-1.4 Units on a scale
Standard Deviation 1.06
|
-1.1 Units on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Visual Evaluation of the Vagina
Vaginal Redness in Mucosa
|
-0.8 Units on a scale
Standard Deviation 0.96
|
-0.6 Units on a scale
Standard Deviation 1.03
|
-0.5 Units on a scale
Standard Deviation 1.07
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=63 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Estradiol (E2) Levels
|
0.75 pg/mL
Standard Deviation 3.27
|
0.94 pg/mL
Standard Deviation 5.97
|
0.15 pg/mL
Standard Deviation 0.79
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=63 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Luteinizing Hormone (LH) Levels
|
-2.02 IU/L
Standard Deviation 5.26
|
-2.86 IU/L
Standard Deviation 6.97
|
-0.83 IU/L
Standard Deviation 4.82
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=63 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Follicle Stimulating Hormone (FSH) Levels
|
-7.44 IU/L
Standard Deviation 11.78
|
-9.87 IU/L
Standard Deviation 14.00
|
-4.10 IU/L
Standard Deviation 11.37
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=63 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels
|
11.71 nmol/L
Standard Deviation 19.64
|
22.64 nmol/L
Standard Deviation 28.07
|
-2.74 nmol/L
Standard Deviation 12.84
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=63 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Testosterone (Total) Levels
|
1.61 ng/dL
Standard Deviation 5.29
|
2.59 ng/dL
Standard Deviation 5.75
|
-0.76 ng/dL
Standard Deviation 7.18
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=63 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Testosterone (Free) Levels
|
-0.01 ng/dL
Standard Deviation 0.13
|
-0.00 ng/dL
Standard Deviation 0.22
|
-0.03 ng/dL
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in E2 Levels
|
0.06 pg/mL
Standard Deviation 1.27
|
-0.02 pg/mL
Standard Deviation 1.05
|
0.14 pg/mL
Standard Deviation 0.69
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in LH Levels
|
-2.65 IU/L
Standard Deviation 6.73
|
-4.95 IU/L
Standard Deviation 7.59
|
-0.09 IU/L
Standard Deviation 5.45
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in FSH Levels
|
-12.39 IU/L
Standard Deviation 16.88
|
-15.60 IU/L
Standard Deviation 13.32
|
-6.29 IU/L
Standard Deviation 17.39
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in SHBG Levels
|
11.94 nmol/L
Standard Deviation 20.81
|
28.09 nmol/L
Standard Deviation 25.62
|
-5.94 nmol/L
Standard Deviation 13.33
|
PRIMARY outcome
Timeframe: Week 52 (Visit 6)Mammography was done for the detection of characteristic masses and microcalcifications in the breast.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=62 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=69 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=49 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Assessment of Mammography
Breast cyst
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Assessment of Mammography
Breast mass
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Assessment of Mammography
Breast microcalcification
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Assessment of Mammography
Mammogram abnormal
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Testosterone (Total) Levels
|
1.92 ng/dL
Standard Deviation 5.13
|
3.48 ng/dL
Standard Deviation 7.86
|
-0.95 ng/dL
Standard Deviation 4.60
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Testosterone (Free) Levels
|
0.02 ng/dL
Standard Deviation 0.10
|
-0.01 ng/dL
Standard Deviation 0.15
|
0.01 ng/dL
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=63 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Antithrombin Antigen, P Levels
|
0.7 percent change
Standard Deviation 10.15
|
-2.4 percent change
Standard Deviation 11.23
|
1.2 percent change
Standard Deviation 10.49
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=63 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Fibrinogen Levels
|
-29.1 mg/dL
Standard Deviation 83.18
|
-25.9 mg/dL
Standard Deviation 63.17
|
12.1 mg/dL
Standard Deviation 70.52
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=63 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Protein C Ag, P Levels
|
8.2 percent change
Standard Deviation 20.20
|
-2.0 percent change
Standard Deviation 20.68
|
14.2 percent change
Standard Deviation 21.96
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=63 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Protein S Ag (Free), P Levels
|
4.7 percent change
Standard Deviation 13.33
|
6.8 percent change
Standard Deviation 12.82
|
4.8 percent change
Standard Deviation 9.79
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=63 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Thromboplastin Time
|
0.5 s
Standard Deviation 7.48
|
-0.6 s
Standard Deviation 3.37
|
0.3 s
Standard Deviation 2.87
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Antithrombin Antigen, P Levels
|
5.1 percent change
Standard Deviation 9.56
|
1.0 percent change
Standard Deviation 9.28
|
7.1 percent change
Standard Deviation 11.64
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Fibrinogen Levels
|
-24.0 mg/dL
Standard Deviation 61.79
|
-36.0 mg/dL
Standard Deviation 67.82
|
7.4 mg/dL
Standard Deviation 96.67
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Protein C Ag, P Levels
|
4.9 percent change
Standard Deviation 17.11
|
-2.9 percent change
Standard Deviation 19.20
|
10.6 percent change
Standard Deviation 20.11
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Protein S Ag (Free), P Levels
|
7.1 percent change
Standard Deviation 16.77
|
11.1 percent change
Standard Deviation 13.78
|
9.3 percent change
Standard Deviation 15.92
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Thromboplastin Time
|
0.4 s
Standard Deviation 4.13
|
0.5 s
Standard Deviation 3.43
|
1.2 s
Standard Deviation 5.05
|
PRIMARY outcome
Timeframe: Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 65 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Breast palpation was done by the investigator to assess abnormalities in the breast.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=65 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Assessment of Breast Palpation
Not done
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Assessment of Breast Palpation
Normal
|
52 Participants
|
64 Participants
|
41 Participants
|
|
Assessment of Breast Palpation
Abnormal
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Breast palpation was done by the investigator to assess abnormalities in the breast.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Assessment of Breast Palpation
Normal
|
49 Participants
|
57 Participants
|
35 Participants
|
|
Assessment of Breast Palpation
Abnormal
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Change from baseline
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=51 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=61 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Assessment of Hematology Tests
Leukocytes (WBC)
|
-0.008 (x10(9)/L)
Standard Deviation 1.2147
|
-0.211 (x10(9)/L)
Standard Deviation 1.3608
|
0.207 (x10(9)/L)
Standard Deviation 1.0489
|
|
Assessment of Hematology Tests
Basophils
|
0.006 (x10(9)/L)
Standard Deviation 0.0240
|
0.001 (x10(9)/L)
Standard Deviation 0.0215
|
-0.005 (x10(9)/L)
Standard Deviation 0.0186
|
|
Assessment of Hematology Tests
Lymphocytes
|
-0.035 (x10(9)/L)
Standard Deviation 0.3169
|
-0.064 (x10(9)/L)
Standard Deviation 0.4004
|
0.116 (x10(9)/L)
Standard Deviation 0.4972
|
|
Assessment of Hematology Tests
Monocytes
|
0.025 (x10(9)/L)
Standard Deviation 0.1297
|
-0.042 (x10(9)/L)
Standard Deviation 0.1127
|
0.009 (x10(9)/L)
Standard Deviation 0.1362
|
|
Assessment of Hematology Tests
Neutrophils
|
-0.010 (x10(9)/L)
Standard Deviation 0.9812
|
-0.094 (x10(9)/L)
Standard Deviation 1.2380
|
0.083 (x10(9)/L)
Standard Deviation 0.7953
|
|
Assessment of Hematology Tests
Eosinophils
|
-0.010 (x10(9)/L)
Standard Deviation 0.0955
|
-0.009 (x10(9)/L)
Standard Deviation 0.1072
|
0.002 (x10(9)/L)
Standard Deviation 0.1168
|
|
Assessment of Hematology Tests
Platelet Count
|
-5.2 (x10(9)/L)
Standard Deviation 31.23
|
-5.6 (x10(9)/L)
Standard Deviation 30.53
|
-4.5 (x10(9)/L)
Standard Deviation 31.56
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=51 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=61 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Erythrocyte (RBC) Levels
|
-0.081 (x10(12)/L)
Standard Deviation 0.2232
|
-0.089 (x10(12)/L)
Standard Deviation 0.2500
|
0.026 (x10(12)/L)
Standard Deviation 0.2240
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=51 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=61 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Hemogobin Levels
|
-0.150 g/dL
Standard Deviation 0.6664
|
-0.165 g/dL
Standard Deviation 0.6668
|
0.140 g/dL
Standard Deviation 0.6247
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=51 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=61 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Hematocrit Levels
|
-0.435 percent change
Standard Deviation 2.0189
|
-0.529 percent change
Standard Deviation 2.1667
|
0.398 percent change
Standard Deviation 1.9951
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Change from baseline
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Assessment of Hematology Test Values
Leukocytes (WBC)
|
0.061 (x10(9)/L)
Standard Deviation 1.7480
|
-0.217 (x10(9)/L)
Standard Deviation 0.9597
|
0.371 (x10(9)/L)
Standard Deviation 1.3680
|
|
Assessment of Hematology Test Values
Basophils
|
0.003 (x10(9)/L)
Standard Deviation 0.0181
|
0.002 (x10(9)/L)
Standard Deviation 0.0281
|
-0.003 (x10(9)/L)
Standard Deviation 0.0214
|
|
Assessment of Hematology Test Values
Lymphocytes
|
-0.120 (x10(9)/L)
Standard Deviation 0.4796
|
0.001 (x10(9)/L)
Standard Deviation 0.3339
|
-0.028 (x10(9)/L)
Standard Deviation 0.3352
|
|
Assessment of Hematology Test Values
Monocytes
|
-0.024 (x10(9)/L)
Standard Deviation 0.1065
|
-0.028 (x10(9)/L)
Standard Deviation 0.1017
|
0.021 (x10(9)/L)
Standard Deviation 0.1216
|
|
Assessment of Hematology Test Values
Neutrophils
|
0.194 (x10(9)/L)
Standard Deviation 1.7491
|
-0.258 (x10(9)/L)
Standard Deviation 0.9189
|
0.377 (x10(9)/L)
Standard Deviation 1.3568
|
|
Assessment of Hematology Test Values
Eosinophils
|
-0.003 (x10(9)/L)
Standard Deviation 0.1029
|
-0.005 (x10(9)/L)
Standard Deviation 0.0823
|
0.021 (x10(9)/L)
Standard Deviation 0.1889
|
|
Assessment of Hematology Test Values
Platelet Count
|
-11.2 (x10(9)/L)
Standard Deviation 34.86
|
-16.4 (x10(9)/L)
Standard Deviation 27.80
|
-11.3 (x10(9)/L)
Standard Deviation 37.75
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Erythrocyte (RBC) Levels
|
-0.087 (x10(12)/L)
Standard Deviation 0.2115
|
-0.155 (x10(12)/L)
Standard Deviation 0.2113
|
0.028 (x10(12)/L)
Standard Deviation 0.2350
|
PRIMARY outcome
Timeframe: Baseine to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin Levels
|
-0.141 g/dL
Standard Deviation 0.6261
|
-0.431 g/dL
Standard Deviation 0.6367
|
0.094 g/dL
Standard Deviation 0.6121
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Hematocrit Levels
|
-0.445 percent change
Standard Deviation 1.9207
|
-1.152 percent change
Standard Deviation 1.9113
|
0.174 percent change
Standard Deviation 2.0823
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 64 subjects in the ospemifene 30 mg group, 64 out of 69 subjects in the ospemifene 60 mg group, and 41 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=64 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=41 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in pH of Urine
|
0.2 pH
Standard Deviation 1.28
|
0.0 pH
Standard Deviation 0.97
|
0.1 pH
Standard Deviation 1.15
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 64 subjects in the ospemifene 30 mg group, 64 out of 69 subjects in the ospemifene 60 mg group, and 41 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=64 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=41 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Specific Gravtiy of Urine
|
-0.002 units
Standard Deviation 0.0074
|
-0.003 units
Standard Deviation 0.0062
|
-0.000 units
Standard Deviation 0.0065
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 57 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=57 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in pH of Urine
|
0.1 pH
Standard Deviation 1.17
|
0.0 pH
Standard Deviation 1.15
|
0.2 pH
Standard Deviation 1.20
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 57 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=57 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Specific Gravity of Urine
|
-0.001 units
Standard Deviation 0.0061
|
-0.002 units
Standard Deviation 0.0074
|
-0.001 units
Standard Deviation 0.0067
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=66 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP)
|
-2.1 mmHg
Standard Deviation 15.33
|
2.4 mmHg
Standard Deviation 12.16
|
0.5 mmHg
Standard Deviation 11.16
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=66 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure (DBP)
|
-2.0 mmHg
Standard Deviation 9.49
|
0.5 mmHg
Standard Deviation 8.29
|
0.3 mmHg
Standard Deviation 8.07
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=66 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Pulse Rate
|
2.0 bpm
Standard Deviation 11.71
|
0.8 bpm
Standard Deviation 10.61
|
2.2 bpm
Standard Deviation 8.60
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 5)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=66 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Weight
|
-0.88 kg
Standard Deviation 3.902
|
0.66 kg
Standard Deviation 2.997
|
0.78 kg
Standard Deviation 2.732
|
PRIMARY outcome
Timeframe: Baseline to Week 26Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=52 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=66 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=42 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in BMI
|
-0.331 kg/m^2
Standard Deviation 1.4659
|
0.253 kg/m^2
Standard Deviation 1.1244
|
0.293 kg/m^2
Standard Deviation 1.0131
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in SBP
|
-4.5 mmHg
Standard Deviation 15.28
|
0.9 mmHg
Standard Deviation 15.30
|
4.2 mmHg
Standard Deviation 15.21
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in DBP
|
-2.5 mmHg
Standard Deviation 10.32
|
0.7 mmHg
Standard Deviation 9.97
|
0.8 mmHg
Standard Deviation 7.85
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Pulse Rate
|
2.6 bpm
Standard Deviation 9.78
|
-0.5 bpm
Standard Deviation 12.05
|
2.9 bpm
Standard Deviation 6.61
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in Weight
|
-0.99 kg
Standard Deviation 4.975
|
0.98 kg
Standard Deviation 3.055
|
1.99 kg
Standard Deviation 3.084
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 6)Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
Outcome measures
| Measure |
Ospemifene 30 mg (Dose 1)
n=49 Participants
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=58 Participants
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=35 Participants
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Change From Baseline in BMI
|
-0.379 kg/m^2
Standard Deviation 1.8594
|
0.376 kg/m^2
Standard Deviation 1.1942
|
0.748 kg/m^2
Standard Deviation 1.1672
|
Adverse Events
Ospemifene 30 mg (Dose 1)
Ospemifene 60 mg (Dose 2)
Placebo
Serious adverse events
| Measure |
Ospemifene 30 mg (Dose 1)
n=62 participants at risk
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=69 participants at risk
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=49 participants at risk
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/62 • 40 weeks
|
1.4%
1/69 • 40 weeks
|
0.00%
0/49 • 40 weeks
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/62 • 40 weeks
|
1.4%
1/69 • 40 weeks
|
0.00%
0/49 • 40 weeks
|
|
Infections and infestations
Encephalitis Herpes
|
0.00%
0/62 • 40 weeks
|
1.4%
1/69 • 40 weeks
|
0.00%
0/49 • 40 weeks
|
|
Infections and infestations
Meningitis Candida
|
0.00%
0/62 • 40 weeks
|
1.4%
1/69 • 40 weeks
|
0.00%
0/49 • 40 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/62 • 40 weeks
|
1.4%
1/69 • 40 weeks
|
0.00%
0/49 • 40 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
1.6%
1/62 • 40 weeks
|
0.00%
0/69 • 40 weeks
|
0.00%
0/49 • 40 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.6%
1/62 • 40 weeks
|
0.00%
0/69 • 40 weeks
|
0.00%
0/49 • 40 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer In Situ
|
0.00%
0/62 • 40 weeks
|
0.00%
0/69 • 40 weeks
|
2.0%
1/49 • 40 weeks
|
|
Nervous system disorders
Headache
|
1.6%
1/62 • 40 weeks
|
0.00%
0/69 • 40 weeks
|
0.00%
0/49 • 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/62 • 40 weeks
|
1.4%
1/69 • 40 weeks
|
0.00%
0/49 • 40 weeks
|
|
Surgical and medical procedures
Breast Prosthesis Implantation
|
0.00%
0/62 • 40 weeks
|
1.4%
1/69 • 40 weeks
|
0.00%
0/49 • 40 weeks
|
Other adverse events
| Measure |
Ospemifene 30 mg (Dose 1)
n=62 participants at risk
Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Ospemifene 60 mg (Dose 2)
n=69 participants at risk
Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
|
Placebo
n=49 participants at risk
Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/62 • 40 weeks
|
1.4%
1/69 • 40 weeks
|
6.1%
3/49 • 40 weeks
|
|
Infections and infestations
Sinusitis
|
6.5%
4/62 • 40 weeks
|
2.9%
2/69 • 40 weeks
|
4.1%
2/49 • 40 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
8.1%
5/62 • 40 weeks
|
8.7%
6/69 • 40 weeks
|
8.2%
4/49 • 40 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.6%
1/62 • 40 weeks
|
5.8%
4/69 • 40 weeks
|
2.0%
1/49 • 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/62 • 40 weeks
|
5.8%
4/69 • 40 weeks
|
0.00%
0/49 • 40 weeks
|
|
Vascular disorders
Hot Flush
|
3.2%
2/62 • 40 weeks
|
7.2%
5/69 • 40 weeks
|
4.1%
2/49 • 40 weeks
|
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