| Primary | Incidence of Adverse Events (AEs) | | | Posted | | Number | | Participants | | Week 20 (Phone Contact) to Week 56 (Visit 7) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| | | Title | Denominators | Categories |
|---|
| Treatment-Emergent AE | | | | Related AE (Possibly/Probably/Definitely Related) | |
| |
| Primary | Assessment of Cervical Pap Smear Samples | 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. | 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. | Posted | | Number | | Participants | | Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Assessment of Endometrial Biopsy | Assessments were based on Blaustein's classification. | 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. | Posted | | Number | | Participants | | Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Mean Percent Change From Baseline in Serum Lipids | | | Posted | | Mean | Standard Deviation | percent change | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Mean Percent Change From Baseline in Serum Lipids | | | Posted | | Mean | Standard Deviation | percent change | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Mean Change in Blood Chemistry Parameters | | | Posted | | Mean | Standard Deviation | U/L | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Mean Change in Blood Chemistry Parameters | | | Posted | | Mean | Standard Deviation | U/L | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU) | Mean change in endometrial thickness from baseline | 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. | Posted | | Mean | Standard Deviation | mm | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Assessment of Endometrial Safety With a TVU | Mean change in endometrial thickness from baseline | 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. | Posted | | Mean | Standard Deviation | mm | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Visual Evaluation of the Vagina | 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). | 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. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Visual Evaluation of the Vagina | 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). | 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. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Estradiol (E2) Levels | | 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. | Posted | | Mean | Standard Deviation | pg/mL | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Luteinizing Hormone (LH) Levels | | 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. | Posted | | Mean | Standard Deviation | IU/L | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Follicle Stimulating Hormone (FSH) Levels | | 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. | Posted | | Mean | Standard Deviation | IU/L | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels | | 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. | Posted | | Mean | Standard Deviation | nmol/L | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Testosterone (Total) Levels | | 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. | Posted | | Mean | Standard Deviation | ng/dL | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Testosterone (Free) Levels | | 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. | Posted | | Mean | Standard Deviation | ng/dL | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in E2 Levels | | 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. | Posted | | Mean | Standard Deviation | pg/mL | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in LH Levels | | 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. | Posted | | Mean | Standard Deviation | IU/L | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in FSH Levels | | 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. | Posted | | Mean | Standard Deviation | IU/L | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in SHBG Levels | | 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. | Posted | | Mean | Standard Deviation | nmol/L | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Assessment of Mammography | Mammography was done for the detection of characteristic masses and microcalcifications in the breast. | | Posted | | Number | | Participants | | Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Testosterone (Total) Levels | | 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. | Posted | | Mean | Standard Deviation | ng/dL | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Testosterone (Free) Levels | | 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. | Posted | | Mean | Standard Deviation | ng/dL | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Antithrombin Antigen, P Levels | | 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. | Posted | | Mean | Standard Deviation | percent change | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Fibrinogen Levels | | 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. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Protein C Ag, P Levels | | 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. | Posted | | Mean | Standard Deviation | percent change | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Protein S Ag (Free), P Levels | | 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. | Posted | | Mean | Standard Deviation | percent change | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Thromboplastin Time | | 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. | Posted | | Mean | Standard Deviation | s | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Antithrombin Antigen, P Levels | | 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. | Posted | | Mean | Standard Deviation | percent change | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Fibrinogen Levels | | 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. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Protein C Ag, P Levels | | 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. | Posted | | Mean | Standard Deviation | percent change | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Protein S Ag (Free), P Levels | | 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. | Posted | | Mean | Standard Deviation | percent change | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
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| Primary | Change From Baseline in Thromboplastin Time | | 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. | Posted | | Mean | Standard Deviation | s | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
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| Primary | Assessment of Breast Palpation | Breast palpation was done by the investigator to assess abnormalities in the breast. | 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. | Posted | | Number | | Participants | | Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
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| Primary | Assessment of Breast Palpation | Breast palpation was done by the investigator to assess abnormalities in the breast. | 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. | Posted | | Number | | Participants | | Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
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| Primary | Assessment of Hematology Tests | | 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. | Posted | | Mean | Standard Deviation | (x10(9)/L) | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
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| Primary | Change From Baseline in Erythrocyte (RBC) Levels | | 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. | Posted | | Mean | Standard Deviation | (x10(12)/L) | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
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| Primary | Change From Baseline in Hemogobin Levels | | 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. | Posted | | Mean | Standard Deviation | g/dL | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
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| Primary | Change From Baseline in Hematocrit Levels | | 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. | Posted | | Mean | Standard Deviation | percent change | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
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| Primary | Assessment of Hematology Test Values | | 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. | Posted | | Mean | Standard Deviation | (x10(9)/L) | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Erythrocyte (RBC) Levels | | 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. | Posted | | Mean | Standard Deviation | (x10(12)/L) | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
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| Primary | Change From Baseline in Hemoglobin Levels | | 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. | Posted | | Mean | Standard Deviation | g/dL | | Baseine to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Hematocrit Levels | | 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. | Posted | | Mean | Standard Deviation | percent change | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
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| Primary | Change From Baseline in pH of Urine | | 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. | Posted | | Mean | Standard Deviation | pH | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
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| Primary | Change From Baseline in Specific Gravtiy of Urine | | 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. | Posted | | Mean | Standard Deviation | units | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
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| Primary | Change From Baseline in pH of Urine | | 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. | Posted | | Mean | Standard Deviation | pH | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Specific Gravity of Urine | | 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. | Posted | | Mean | Standard Deviation | units | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
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| Primary | Change From Baseline in Systolic Blood Pressure (SBP) | | 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. | Posted | | Mean | Standard Deviation | mmHg | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
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| Primary | Change From Baseline in Diastolic Blood Pressure (DBP) | | 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. | Posted | | Mean | Standard Deviation | mmHg | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
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| Primary | Change From Baseline in Pulse Rate | | 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. | Posted | | Mean | Standard Deviation | bpm | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
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| Primary | Change From Baseline in Weight | | 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. | Posted | | Mean | Standard Deviation | kg | | Baseline to Week 26 (Visit 5) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in BMI | | 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. | Posted | | Mean | Standard Deviation | kg/m^2 | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in SBP | | 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. | Posted | | Mean | Standard Deviation | mmHg | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in DBP | | 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. | Posted | | Mean | Standard Deviation | mmHg | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Pulse Rate | | 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. | Posted | | Mean | Standard Deviation | bpm | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in Weight | | 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. | Posted | | Mean | Standard Deviation | kg | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
| |
| Primary | Change From Baseline in BMI | | 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. | Posted | | Mean | Standard Deviation | kg/m^2 | | Baseline to Week 52 (Visit 6) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | Placebo | Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks |
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