Trial Outcomes & Findings for Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus (NCT NCT01586364)
NCT ID: NCT01586364
Last Updated: 2018-05-21
Results Overview
COMPLETED
PHASE3
301 participants
Week 13 (Phone Contact) to Week 56 (Visit 4)
2018-05-21
Participant Flow
Participant milestones
| Measure |
Treatment Arm = 60 mg Ospemifene
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Overall Study
STARTED
|
301
|
|
Overall Study
COMPLETED
|
184
|
|
Overall Study
NOT COMPLETED
|
117
|
Reasons for withdrawal
| Measure |
Treatment Arm = 60 mg Ospemifene
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
40
|
|
Overall Study
Adverse Event
|
37
|
|
Overall Study
Lost to Follow-up
|
17
|
|
Overall Study
Protocol Violation
|
16
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Other-Did not feel better post-treatment
|
1
|
|
Overall Study
Other-Subject wasn't getting much relief
|
1
|
|
Overall Study
Other-Site closure due to PI illness
|
1
|
|
Overall Study
Other-PI discretion, site closing
|
2
|
|
Overall Study
Other-Not specified
|
1
|
Baseline Characteristics
Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus
Baseline characteristics by cohort
| Measure |
Treatment Arm = 60 mg Ospemifene
n=301 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Age, Continuous
|
59.4 Years
STANDARD_DEVIATION 6.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
301 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
280 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
278 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
|
Height
|
161.90 cm
STANDARD_DEVIATION 6.026 • n=5 Participants
|
|
Weight
|
70.54 kg
STANDARD_DEVIATION 13.024 • n=5 Participants
|
|
Body mass index (BMI)
|
26.865 kg/m^2
STANDARD_DEVIATION 4.4106 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 13 (Phone Contact) to Week 56 (Visit 4)Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=301 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Incidence of Adverse Events (AEs)
Treatment-Emergent AE
|
220 Participants
|
|
Incidence of Adverse Events (AEs)
Related AE (Possibly/Probably/Definitely Related)
|
67 Participants
|
|
Incidence of Adverse Events (AEs)
AE Causing Study Drug Discontinuation
|
34 Participants
|
|
Incidence of Adverse Events (AEs)
Serious AE
|
13 Participants
|
|
Incidence of Adverse Events (AEs)
Severe AE
|
38 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, 241 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=241 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Serum Lipid Levels at Visit 2
Total Cholesterol
|
1.59 percent change
Standard Deviation 17.772
|
|
Change From Baseline in Serum Lipid Levels at Visit 2
Low-density lipoprotein cholesterol (LDL-C)
|
2.83 percent change
Standard Deviation 29.420
|
|
Change From Baseline in Serum Lipid Levels at Visit 2
High-density lipoprotein cholesterol (HDL-C)
|
2.81 percent change
Standard Deviation 16.009
|
|
Change From Baseline in Serum Lipid Levels at Visit 2
Triglycerides
|
11.51 percent change
Standard Deviation 43.422
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, 195 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=195 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Serum Lipid Levels at Visit 3
Total Cholesterol
|
-0.02 percent change
Standard Deviation 16.025
|
|
Change From Baseline in Serum Lipid Levels at Visit 3
LDL-C
|
-0.54 percent change
Standard Deviation 22.932
|
|
Change From Baseline in Serum Lipid Levels at Visit 3
HDL-C
|
2.74 percent change
Standard Deviation 15.226
|
|
Change From Baseline in Serum Lipid Levels at Visit 3
Triglycerides
|
13.07 percent change
Standard Deviation 43.877
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.
Systolic blood pressure (SBP), diastolic blood pressure (DBP)
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=244 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Blood Pressure at Visit 2
SBP
|
-1.2 mmHg
Standard Deviation 15.91
|
|
Change From Baseline in Blood Pressure at Visit 2
DBP
|
-0.7 mmHg
Standard Deviation 9.32
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=244 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Pulse Rate at Visit 2
|
2.1 bpm
Standard Deviation 10.22
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=244 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Weight at Visit 2
|
0.798 kg
Standard Deviation 3.6022
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=244 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Body Mass Index (BMI) at Visit 2
|
0.309 kg/m^2
Standard Deviation 1.3628
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=199 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Blood Pressure at Visit 3
SBP
|
-1.2 mmHg
Standard Deviation 16.35
|
|
Change From Baseline in Blood Pressure at Visit 3
DBP
|
-1.0 mmHg
Standard Deviation 9.88
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=199 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Pulse Rate at Visit 3
|
3.3 bpm
Standard Deviation 9.43
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=199 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Weight at Visit 3
|
1.122 kg
Standard Deviation 8.2464
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=199 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in BMI at Visit 3
|
0.439 kg/m^2
Standard Deviation 3.2779
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=243 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Visual Evaluation of Vagina at Visit 2
Petechiae
|
-0.6 units on a scale
Standard Deviation 0.86
|
|
Change From Baseline in Visual Evaluation of Vagina at Visit 2
Pallor
|
-1.0 units on a scale
Standard Deviation 0.95
|
|
Change From Baseline in Visual Evaluation of Vagina at Visit 2
Friability
|
-0.8 units on a scale
Standard Deviation 0.89
|
|
Change From Baseline in Visual Evaluation of Vagina at Visit 2
Vaginal Dryness in Mucosa
|
-1.4 units on a scale
Standard Deviation 0.87
|
|
Change From Baseline in Visual Evaluation of Vagina at Visit 2
Vaginal Redness in Mucosa
|
-0.6 units on a scale
Standard Deviation 0.92
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 198 out of 301 subjects were analyzed.
Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=198 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Visual Evaluation of Vagina at Visit 3
Petechiae
|
-0.6 units on a scale
Standard Deviation 0.90
|
|
Change From Baseline in Visual Evaluation of Vagina at Visit 3
Pallor
|
-1.2 units on a scale
Standard Deviation 0.95
|
|
Change From Baseline in Visual Evaluation of Vagina at Visit 3
Friability
|
-0.8 units on a scale
Standard Deviation 0.91
|
|
Change From Baseline in Visual Evaluation of Vagina at Visit 3
Vaginal Dryness in Mucosa
|
-1.5 units on a scale
Standard Deviation 0.88
|
|
Change From Baseline in Visual Evaluation of Vagina at Visit 3
Vaginal Redness in Mucosa
|
-0.8 units on a scale
Standard Deviation 0.89
|
PRIMARY outcome
Timeframe: Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 16 out of 301 subjects were analyzed.
Cervical Pap smear samples are 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 |
Treatment Arm = 60 mg Ospemifene
n=16 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Assessment of Cervical Pap Smear Samples (if Cervix is Intact)
Atypical Squamous Cells-Undetermined Significance
|
1 Participants
|
|
Assessment of Cervical Pap Smear Samples (if Cervix is Intact)
Negative for Intraepithelial Lesion or Malignancy
|
15 Participants
|
PRIMARY outcome
Timeframe: Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Breast palpation was used to assess breast abnormalities.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=243 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Assessment of Breast Palpation at Visit 2
Normal
|
243 Participants
|
|
Assessment of Breast Palpation at Visit 2
Abnormal
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.
Breast palpation was used to assess breast abnormalities.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=199 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Assessment of Breast Palpation at Visit 3
Normal
|
198 Participants
|
|
Assessment of Breast Palpation at Visit 3
Abnormal
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=242 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2
Antithrombin Antigen, Plasma
|
0.4 percent change
Standard Deviation 10.70
|
|
Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2
Protein C Antigen, Plasma
|
-1.3 percent change
Standard Deviation 21.62
|
|
Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2
Protein S Antigen, Free, Plasma
|
9.6 percent change
Standard Deviation 15.19
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=242 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2
|
-1.5 s
Standard Deviation 14.36
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=242 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2
|
-25.4 mg/dL
Standard Deviation 80.30
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=194 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3
Antithrombin Antigen, Plasma
|
2.4 percent change
Standard Deviation 10.80
|
|
Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3
Protein C Antigen, Plasma
|
4.3 percent change
Standard Deviation 22.57
|
|
Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3
Protein S Antigen, Free, Plasma
|
12.9 percent change
Standard Deviation 20.40
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=194 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3
|
-0.7 s
Standard Deviation 17.24
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=194 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3
|
-29.9 mg/dL
Standard Deviation 77.19
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=240 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2
Leukocytes
|
-0.17 (x10(9)/L)
Standard Deviation 1.201
|
|
Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2
Lymphocytes
|
-0.058 (x10(9)/L)
Standard Deviation 0.4025
|
|
Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2
Monocytes
|
-0.012 (x10(9)/L)
Standard Deviation 0.1557
|
|
Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2
Platelet Count
|
-6.2 (x10(9)/L)
Standard Deviation 41.68
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=240 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Erythrocyte Levels at Visit 2
|
-0.098 (x10(12)/L)
Standard Deviation 0.2454
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=240 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Hemoglobin Levels at Visit 2
|
-0.29 g/dL
Standard Deviation 0.705
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=240 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2
Hematocrit
|
-0.86 percent change
Standard Deviation 2.151
|
|
Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2
RBC distribution width
|
0.07 percent change
Standard Deviation 0.776
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=240 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2
MCV, free
|
0.02 fL
Standard Deviation 1.732
|
|
Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2
MPV
|
0.01 fL
Standard Deviation 0.521
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=196 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3
Leukocytes
|
-0.05 (x10(9)/L)
Standard Deviation 1.270
|
|
Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3
Lymphocytes
|
-0.010 (x10(9)/L)
Standard Deviation 0.4410
|
|
Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3
Monocytes
|
-0.021 (x10(9)/L)
Standard Deviation 0.1619
|
|
Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3
Platelet Count
|
-13.5 (x10(9)/L)
Standard Deviation 36.92
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=196 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Erythrocyte Levels at Visit 3
|
-0.108 (x10(12)/L)
Standard Deviation 0.2745
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=196 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Hemoglobin Levels at Visit 3
|
-0.35 g/dL
Standard Deviation 0.840
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=196 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3
Hematocrit
|
-0.97 percent change
Standard Deviation 2.490
|
|
Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3
RBC distribution width
|
0.14 percent change
Standard Deviation 0.834
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=196 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in MCV and MPV at Visit 3
MCV, free
|
0.01 fL
Standard Deviation 2.081
|
|
Change From Baseline in MCV and MPV at Visit 3
MPV
|
-0.03 fL
Standard Deviation 0.512
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=243 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Albumin and Total Protein Levels at Visit 2
Albumin, Serum
|
-0.10 g/dL
Standard Deviation 0.248
|
|
Change From Baseline in Albumin and Total Protein Levels at Visit 2
Total Protein, Serum
|
-0.14 g/dL
Standard Deviation 0.399
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=243 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2
ALT, Serum
|
-3.7 U/L
Standard Deviation 10.93
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2
AST, Serum
|
-0.1 U/L
Standard Deviation 5.62
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2
CK, Serum
|
-6.7 U/L
Standard Deviation 46.23
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=243 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2
Bilirubin Total, Serum
|
-0.08 mg/dL
Standard Deviation 0.144
|
|
Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2
Creatinine, Plasma/Serum
|
-0.06 mg/dL
Standard Deviation 0.125
|
|
Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2
Glucose, Plasma/Serum
|
3.2 mg/dL
Standard Deviation 17.75
|
|
Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2
Uric Acid, Serum
|
-0.02 mg/dL
Standard Deviation 0.786
|
|
Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2
BUN
|
0.5 mg/dL
Standard Deviation 3.86
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=197 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Albumin and Total Protein Levels at Visit 3
Albumin, Serum
|
-0.08 g/dL
Standard Deviation 0.232
|
|
Change From Baseline in Albumin and Total Protein Levels at Visit 3
Total Protein, Serum
|
-0.19 g/dL
Standard Deviation 0.376
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=197 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in ALT, AST and CK Levels at Visit 3
ALT, Serum
|
-4.1 U/L
Standard Deviation 11.81
|
|
Change From Baseline in ALT, AST and CK Levels at Visit 3
AST, Serum
|
0.2 U/L
Standard Deviation 7.06
|
|
Change From Baseline in ALT, AST and CK Levels at Visit 3
CK, Serum
|
2.6 U/L
Standard Deviation 109.35
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=197 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3
Bilirubin Total, Serum
|
-0.08 mg/dL
Standard Deviation 0.151
|
|
Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3
Creatinine, Plasma/Serum
|
-0.04 mg/dL
Standard Deviation 0.125
|
|
Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3
Glucose, Plasma/Serum
|
3.6 mg/dL
Standard Deviation 16.47
|
|
Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3
Uric Acid, Serum
|
0.03 mg/dL
Standard Deviation 0.792
|
|
Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3
BUN
|
0.7 mg/dL
Standard Deviation 4.15
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 239 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=239 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in pH of Urine at Visit 2
|
-0.11 pH
Standard Deviation 1.065
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 239 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=239 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Specific Gravity of Urine at Visit 2
|
0.0003 units
Standard Deviation 0.00672
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 195 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=195 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in pH of Urine at Visit 3
|
-0.09 pH
Standard Deviation 1.118
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 195 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=195 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Specific Gravity of Urine at Visit 3
|
-0.0010 units
Standard Deviation 0.00695
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=243 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Estradiol (E2) Levels at Visit 2
|
0.5 pg/mL
Standard Deviation 4.71
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=243 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2
FSH
|
-10.3 IU/L
Standard Deviation 14.13
|
|
Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2
LH
|
-2.2 IU/L
Standard Deviation 6.86
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=243 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2
|
19.5 nmol/L
Standard Deviation 22.67
|
PRIMARY outcome
Timeframe: Baseline to Week 26 (Visit 2)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=243 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Testosterone Levels at Visit 2
Testosterone, Free
|
-0.03 ng/dL
Standard Deviation 0.125
|
|
Change From Baseline in Testosterone Levels at Visit 2
Testosterone, Total
|
1.45 ng/dL
Standard Deviation 5.108
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=196 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in E2 Levels at Visit 3
|
0.4 pg/mL
Standard Deviation 10.28
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=196 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in FSH and LH Levels at Visit 3
FSH
|
-15.9 IU/L
Standard Deviation 13.57
|
|
Change From Baseline in FSH and LH Levels at Visit 3
LH
|
-1.7 IU/L
Standard Deviation 6.70
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=196 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in SHBG Levels at Visit 3
|
20.1 nmol/L
Standard Deviation 23.19
|
PRIMARY outcome
Timeframe: Baseline to Week 52 (Visit 3)Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Outcome measures
| Measure |
Treatment Arm = 60 mg Ospemifene
n=196 Participants
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Change From Baseline in Testosterone Levels at Visit 3
Testosterone, Free
|
0.00 ng/dL
Standard Deviation 0.124
|
|
Change From Baseline in Testosterone Levels at Visit 3
Testosterone, Total
|
2.23 ng/dL
Standard Deviation 5.177
|
Adverse Events
Treatment Arm = 60 mg Ospemifene
Serious adverse events
| Measure |
Treatment Arm = 60 mg Ospemifene
n=301 participants at risk
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.33%
1/301 • 56 weeks
|
|
General disorders
Non-Cardiac Chest Pain
|
0.33%
1/301 • 56 weeks
|
|
Infections and infestations
Diverticulitis
|
0.33%
1/301 • 56 weeks
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.33%
1/301 • 56 weeks
|
|
Injury, poisoning and procedural complications
Overdose
|
0.33%
1/301 • 56 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.33%
1/301 • 56 weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.33%
1/301 • 56 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.33%
1/301 • 56 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal Cancer
|
0.33%
1/301 • 56 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal Meningioma Benign
|
0.33%
1/301 • 56 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.33%
1/301 • 56 weeks
|
|
Nervous system disorders
Haemorrahagic Stroke
|
0.33%
1/301 • 56 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.33%
1/301 • 56 weeks
|
|
Nervous system disorders
Syncope
|
0.33%
1/301 • 56 weeks
|
|
Psychiatric disorders
Anxiety Disorder
|
0.33%
1/301 • 56 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.33%
1/301 • 56 weeks
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.33%
1/301 • 56 weeks
|
Other adverse events
| Measure |
Treatment Arm = 60 mg Ospemifene
n=301 participants at risk
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
|
|---|---|
|
Infections and infestations
Sinusitis
|
8.0%
24/301 • 56 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
8.6%
26/301 • 56 weeks
|
|
Vascular disorders
Hot Flush
|
10.3%
31/301 • 56 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