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| Name | Class |
|---|---|
| QuatRx Pharmaceuticals | INDUSTRY |
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The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ospemifene 60 mg Oral Tablet | Experimental | Participants will take one tablet of ospemifene 60 mg orally, once a day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ospemifene 60Mg Oral Tablet | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Week 13 (Phone Contact) to Week 56 (Visit 4) | |
| Change From Baseline in Serum Lipid Levels at Visit 2 | Baseline to Week 26 (Visit 2) | |
| Change From Baseline in Serum Lipid Levels at Visit 3 | Baseline to Week 52 (Visit 3) | |
| Change From Baseline in Blood Pressure at Visit 2 | Systolic blood pressure (SBP), diastolic blood pressure (DBP) | Baseline to Week 26 (Visit 2) |
| Change From Baseline in Pulse Rate at Visit 2 | Baseline to Week 26 (Visit 2) | |
| Change From Baseline in Weight at Visit 2 | Baseline to Week 26 (Visit 2) | |
| Change From Baseline in Body Mass Index (BMI) at Visit 2 | Baseline to Week 26 (Visit 2) | |
| Change From Baseline in Blood Pressure at Visit 3 | Baseline to Week 52 (Visit 3) | |
| Change From Baseline in Pulse Rate at Visit 3 | Baseline to Week 52 (Visit 3) | |
| Change From Baseline in Weight at Visit 3 | Baseline to Week 52 (Visit 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm = 60 mg Ospemifene | Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm = 60 mg Ospemifene | Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) | Posted | Number | Participants | Week 13 (Phone Contact) to Week 56 (Visit 4) |
|
|
56 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm = 60 mg Ospemifene | Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shionogi Clinical Trials Administrator | Shionogi Inc. | 800-849-9707 | 1454 | shionogiclintrialsadmin@shionogi.com |
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| ID | Term |
|---|---|
| D001284 | Atrophy |
| D014623 | Vaginal Diseases |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C119141 | Ospemifene |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Change From Baseline in BMI at Visit 3 | Baseline to Week 52 (Visit 3) |
| Change From Baseline in Visual Evaluation of Vagina at Visit 2 | Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe) | Baseline to Week 26 (Visit 2) |
| Change From Baseline in Visual Evaluation of Vagina at Visit 3 | Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe) | Baseline to Week 52 (Visit 3) |
| Assessment of Cervical Pap Smear Samples (if Cervix is Intact) | 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. | Week 52 (Visit 3) |
| Assessment of Breast Palpation at Visit 2 | Breast palpation was used to assess breast abnormalities. | Week 26 (Visit 2) |
| Assessment of Breast Palpation at Visit 3 | Breast palpation was used to assess breast abnormalities. | Week 52 (Visit 3) |
| Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2 | Baseline to Week 26 (Visit 2) |
| Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2 | Baseline to Week 26 (Visit 2) |
| Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2 | Baseline to Week 26 (Visit 2) |
| Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3 | Baseline to Week 52 (Visit 3) |
| Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3 | Baseline to Week 52 (Visit 3) |
| Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3 | Baseline to Week 52 (Visit 3) |
| Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2 | Baseline to Week 26 (Visit 2) |
| Change From Baseline in Erythrocyte Levels at Visit 2 | Baseline to Week 26 (Visit 2) |
| Change From Baseline in Hemoglobin Levels at Visit 2 | Baseline to Week 26 (Visit 2) |
| Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2 | Baseline to Week 26 (Visit 2) |
| Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2 | Baseline to Week 26 (Visit 2) |
| Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3 | Baseline to Week 52 (Visit 3) |
| Change From Baseline in Erythrocyte Levels at Visit 3 | Baseline to Week 52 (Visit 3) |
| Change From Baseline in Hemoglobin Levels at Visit 3 | Baseline to Week 52 (Visit 3) |
| Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3 | Baseline to Week 52 (Visit 3) |
| Change From Baseline in MCV and MPV at Visit 3 | Baseline to Week 52 (Visit 3) |
| Change From Baseline in Albumin and Total Protein Levels at Visit 2 | Baseline to Week 26 (Visit 2) |
| Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2 | Baseline to Week 26 (Visit 2) |
| Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2 | Baseline to Week 26 (Visit 2) |
| Change From Baseline in Albumin and Total Protein Levels at Visit 3 | Baseline to Week 52 (Visit 3) |
| Change From Baseline in ALT, AST and CK Levels at Visit 3 | Baseline to Week 52 (Visit 3) |
| Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3 | Baseline to Week 52 (Visit 3) |
| Change From Baseline in pH of Urine at Visit 2 | Baseline to Week 26 (Visit 2) |
| Change From Baseline in Specific Gravity of Urine at Visit 2 | Baseline to Week 26 (Visit 2) |
| Change From Baseline in pH of Urine at Visit 3 | Baseline to Week 52 (Visit 3) |
| Change From Baseline in Specific Gravity of Urine at Visit 3 | Baseline to Week 52 (Visit 3) |
| Change From Baseline in Estradiol (E2) Levels at Visit 2 | Baseline to Week 26 (Visit 2) |
| Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2 | Baseline to Week 26 (Visit 2) |
| Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2 | Baseline to Week 26 (Visit 2) |
| Change From Baseline in Testosterone Levels at Visit 2 | Baseline to Week 26 (Visit 2) |
| Change From Baseline in E2 Levels at Visit 3 | Baseline to Week 52 (Visit 3) |
| Change From Baseline in FSH and LH Levels at Visit 3 | Baseline to Week 52 (Visit 3) |
| Change From Baseline in SHBG Levels at Visit 3 | Baseline to Week 52 (Visit 3) |
| Change From Baseline in Testosterone Levels at Visit 3 | Baseline to Week 52 (Visit 3) |
| Protocol Violation |
|
| Lack of Efficacy |
|
| Other-Did not feel better post-treatment |
|
| Other-Subject wasn't getting much relief |
|
| Other-Site closure due to PI illness |
|
| Other-PI discretion, site closing |
|
| Other-Not specified |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
|
| Primary | Change From Baseline in Serum Lipid Levels at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, 241 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Serum Lipid Levels at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, 195 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in Blood Pressure at Visit 2 | Systolic blood pressure (SBP), diastolic blood pressure (DBP) | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | mmHg | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Pulse Rate at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | bpm | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Weight at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | kg | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Body Mass Index (BMI) at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Blood Pressure at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | mmHg | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in Pulse Rate at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | bpm | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in Weight at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | kg | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in BMI at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in Visual Evaluation of Vagina at Visit 2 | Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe) | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Visual Evaluation of Vagina at Visit 3 | Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe) | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 198 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Assessment of Cervical Pap Smear Samples (if Cervix is Intact) | 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. | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 16 out of 301 subjects were analyzed. | Posted | Number | Participants | Week 52 (Visit 3) |
|
|
|
| Primary | Assessment of Breast Palpation at Visit 2 | Breast palpation was used to assess breast abnormalities. | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed. | Posted | Number | Participants | Week 26 (Visit 2) |
|
|
|
| Primary | Assessment of Breast Palpation at Visit 3 | Breast palpation was used to assess breast abnormalities. | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed. | Posted | Number | Participants | Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | s | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | mg/dL | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | s | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | mg/dL | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | (x10(9)/L) | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Erythrocyte Levels at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | (x10(12)/L) | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Hemoglobin Levels at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | g/dL | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | fL | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | (x10(9)/L) | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in Erythrocyte Levels at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | (x10(12)/L) | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in Hemoglobin Levels at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | g/dL | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in MCV and MPV at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | fL | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in Albumin and Total Protein Levels at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | g/dL | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | U/L | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | mg/dL | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Albumin and Total Protein Levels at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | g/dL | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in ALT, AST and CK Levels at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | U/L | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | mg/dL | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in pH of Urine at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 239 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | pH | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Specific Gravity of Urine at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 239 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | units | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in pH of Urine at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 195 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | pH | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in Specific Gravity of Urine at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 195 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | units | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in Estradiol (E2) Levels at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | pg/mL | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | IU/L | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | nmol/L | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in Testosterone Levels at Visit 2 | The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | ng/dL | Baseline to Week 26 (Visit 2) |
|
|
|
| Primary | Change From Baseline in E2 Levels at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | pg/mL | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in FSH and LH Levels at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | IU/L | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in SHBG Levels at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | nmol/L | Baseline to Week 52 (Visit 3) |
|
|
|
| Primary | Change From Baseline in Testosterone Levels at Visit 3 | The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed. | Posted | Mean | Standard Deviation | ng/dL | Baseline to Week 52 (Visit 3) |
|
|
|
| 13 |
| 301 |
| 74 |
| 301 |
| Non-Cardiac Chest Pain | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Intentional Overdose | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Anal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
|
| Spinal Meningioma Benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
|
| Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
|
| Haemorrahagic Stroke | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Anxiety Disorder | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Thrombophlebitis Superficial | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
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.
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
|
| Triglycerides |
|
|
| Triglycerides |
|
| Title | Measurements |
|---|---|
|
| Vaginal Dryness in Mucosa |
|
| Vaginal Redness in Mucosa |
|
| Title | Measurements |
|---|---|
|
| Vaginal Dryness in Mucosa |
|
| Vaginal Redness in Mucosa |
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Title |
|---|
| Measurements |
|---|
|
| Platelet Count |
|
| Title |
|---|
| Measurements |
|---|
|
| Platelet Count |
|
| Title |
|---|
| Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Uric Acid, Serum |
|
| BUN |
|
|
| Title | Measurements |
|---|
|
| Uric Acid, Serum |
|
| BUN |
|