Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hormos Medical | INDUSTRY |
| QuatRx Pharmaceuticals | INDUSTRY |
The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ospemifene 30 mg/day and nonhormonal vaginal lubricant | Experimental | Subjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. |
|
| Ospemifene 60 mg/day and nonhormonal vaginal lubricant | Experimental | Subjects will receive a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. |
|
| Placebo tablets and nonhormonal vaginal lubricant | Placebo Comparator | Subjects will receive a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ospemifene 30 mg | Drug | 1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness | This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe | Baseline (Randomization) to Week 12 |
| Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity | This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe | Baseline (Randomization) to Week 12 |
| Mean Change From Baseline in Vaginal pH | Baseline (Screening) to Week 12 | |
| Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear | Baseline (Screening) to Week 12 | |
| Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear | Baseline (Screening) to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Visual Evaluation of the Vagina | Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe | Baseline (Screening) to Week 12 |
| Change From Baseline in Severity of VVA Symptoms |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi | Study Director |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2. |
| FG001 | Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2. |
| FG002 | Placebo Tablets and Nonhormonal Vaginal Lubricant | Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2. |
| 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 | Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness | This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Randomization) to Week 12 |
|
16 weeks (Visit 2 [Randomization] to Visit 5)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shionogi Clinical Trials Administrator | Shionogi Inc. | 800-849-9707 | 1454 | shionogiclintrialsadmin@shionogi.com |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C119141 | Ospemifene |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ospemifene 60 mg | Drug | 1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12). |
|
| Placebo | Drug | 1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12). |
|
| Nonhormonal vaginal lubricant | Drug | Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary. |
|
|
This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
| Baseline (Randomization) to Week 12 |
| Change From Baseline in Estradiol Levels | Baseline (Screening) to Week 12 |
| Change From Baseline in Follicle Stimulating Hormone Levels | Baseline (Screening) to Week 12 |
| Change From Baseline in Luteinizing Hormone Levels | Baseline (Screening) to Week 12 |
| Change From Baseline in Sex Hormone Binding Globulin Levels | Baseline (Screening) to Week 12 |
| Change From Baseline in Testosterone (Free) Levels | Baseline (Screening) to Week 12 |
| Change From Baseline in Testosterone (Total) Levels | Baseline (Screening) to Week 12 |
| Change From Baseline in Urinary Symptoms | Baseline (Randomization) to Week 12 |
| Protocol Violation |
|
| Lost to Follow-up |
|
| Other-Subject moved out of country |
|
| Other-Scheduled gastroplasty |
|
| Other-Lack of efficacy |
|
| Other-Refused follow-up visit |
|
| Other-Repeat safety labs-exclusionary |
|
| Other-Relocation |
|
| Other-Study medication lost |
|
| BG001 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant |
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2. |
| BG002 | Placebo Tablets and Nonhormonal Vaginal Lubricant | Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Total number of participants in each arm/group do not match the "Overall Number of Baseline participants" in each Arm/group because "Race" and "Ethnicity" parameters have been combined to ensure faithful reproduction of each parameter, as mentioned in the CSR. | Number | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Intact Uterus? | Number | Participants |
|
| Intact Cervix? | Number | Participants |
|
| Number (No.) of Pregnancies | Mean | Standard Deviation | Pregnancies per participant |
|
| No. of Vaginal Births | Mean | Standard Deviation | Vaginal births per participant |
|
| No. of Urinary Tract Infections in Past 6 Months | Number | Participants |
|
| Currently Experiencing Hot Flashes? | Number | Participants |
|
| No. of Days with Hot Flashes (/month) | Mean | Standard Deviation | Days |
|
| Previous Hormone Treatment | Number | Partcipants |
|
| Percentage of Parabasal Cells at Screening | Mean | Standard Deviation | Percentage of Parabasal Cells |
|
| Percentage of Superficial Cells at Screening | Mean | Standard Deviation | Percentage of Superficial Cells |
|
| Vaginal pH at Screening | Mean | Standard Deviation | Vaginal pH |
|
| Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) by Severity (Overall [Composite]) | Number | Participants |
|
| MBS-Vaginal Dryness at Randomization | Vaginal Dryness was assessed in 102, 118, and 104 subjects in the Ospemifene 30 mg, Ospemifene 60 mg, and Placebo groups, respectively. | Number | Participants |
|
| MBS-Vaginal Pain with Sexual Activity at Randomization | Vaginal Pain with Sexual Activity was assessed in 136, 120, and 122 subjects in the Ospemifeme 30 mg, Ospemifene 60 mg, and Placebo groups, respectively. | Number | Participants |
|
| MBS-Vaginal and/or Vulvar Irritation or Itching at Randomization | Vaginal and/or Vulvar Irritation or Itching was assessed in 39, 30, and 37 subjects in the Ospemifene 30 mg, Ospemifene 60 mg, and Placebo groups, respectively. | Number | Participants |
|
| MBS-Difficult/Painful Urination at Randomization | Difficult/Painful Urination was assessed in 3, 2, and 2 subjects in the Ospemifene 30 mg, Ospemifene 60 mg, and Placebo groups, respectively. | Number | Participants |
|
| MBS-Vaginal Bleeding with Sexual Activity at Randomization | Vaginal Bleeding with Sexual Activity was assessed in 1, 5, and 0 subjects in the Ospemifene 30 mg, Ospemifene 60 mg, and Placebo groups, respectively. | Number | Participants |
|
Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2. |
| OG002 | Placebo Tablets and Nonhormonal Vaginal Lubricant | Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2. |
|
|
| Primary | Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity | This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Randomization) to Week 12 |
|
|
|
| Primary | Mean Change From Baseline in Vaginal pH | Posted | Mean | Standard Deviation | pH | Baseline (Screening) to Week 12 |
|
|
|
| Primary | Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear | Posted | Mean | Standard Deviation | percentage of parabasal cells | Baseline (Screening) to Week 12 |
|
|
|
| Secondary | Change From Baseline in Visual Evaluation of the Vagina | Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Screening) to Week 12 |
|
|
|
| Secondary | Change From Baseline in Severity of VVA Symptoms | This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Randomization) to Week 12 |
|
|
|
| Secondary | Change From Baseline in Estradiol Levels | Analysis populations for each hormone: Ospemifene(30 mg): E2-231, FSH-232, LH-231, SHBG-232, Testosterone(free)-183, Testosterone(total)-183 Ospemifene(60 mg): E2-221, FSH-222, LH-222, SHBG-221, Testosterone(free)-175, Testosterone(total)-176 Placebo: E2-216, FSH-216, LH-216, SHBG-216, Testosterone(free)-178, Testosterone(total)-178 | Posted | Mean | Standard Deviation | pg/mL | Baseline (Screening) to Week 12 |
|
|
|
| Primary | Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear | Posted | Mean | Standard Deviation | percentage of superficial cells | Baseline (Screening) to Week 12 |
|
|
|
| Secondary | Change From Baseline in Follicle Stimulating Hormone Levels | Posted | Mean | Standard Deviation | IU/L | Baseline (Screening) to Week 12 |
|
|
|
| Secondary | Change From Baseline in Luteinizing Hormone Levels | Posted | Mean | Standard Deviation | IU/L | Baseline (Screening) to Week 12 |
|
|
|
| Secondary | Change From Baseline in Sex Hormone Binding Globulin Levels | Posted | Mean | Standard Deviation | nmol/L | Baseline (Screening) to Week 12 |
|
|
|
| Secondary | Change From Baseline in Testosterone (Free) Levels | Posted | Mean | Standard Deviation | ng/dL | Baseline (Screening) to Week 12 |
|
|
|
| Secondary | Change From Baseline in Testosterone (Total) Levels | Posted | Mean | Standard Deviation | ng/dL | Baseline (Screening) to Week 12 |
|
|
|
| Secondary | Change From Baseline in Urinary Symptoms | Posted | Number | Participants | Baseline (Randomization) to Week 12 |
|
|
|
| 5 |
| 282 |
| 99 |
| 282 |
| EG001 | Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2. | 0 | 276 | 99 | 276 |
| EG002 | Placebo Tablets and Nonhormonal Vaginal Lubricant | Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2. | 4 | 268 | 49 | 268 |
| Pericarditis | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| Duodenal Stenosis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Red Blood Cell Sedimentation Rate Increased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| Breast Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Psychotic Disorder | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Gastric Bypass | Surgical and medical procedures | MedDRA 9.0 | Systematic Assessment |
|
| Fungal Infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Vulvovaginal Mycotic Infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Vaginal Discharge | Reproductive system and breast disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA 9.0 | 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 |
|
| Friability |
|
| Vaginal dryness in mucosa |
|
| Vaginal redness in mucosa |
|
|
| Vulvar/vaginal itching or irritation |
|
| Difficult/painful urination |
|
| Vaginal bleeding associated with sexual activity |
|
|
| Urine leakage (feeling of urgency)-Improved |
|
| Urine leakage (feeling of urgency)-Worsened |
|
| Urine leakage with physical exertion-Improved |
|
| Urine leakage with physical exertion-Worsened |
|
| Small amount of urine leakage-Improved |
|
| Small amount of urine leakage-Worsened |
|
| Difficulty emptying bladder-Improved |
|
| Difficulty emptying bladder-Worsened |
|
| Pain in lower abdominal/genital area-Improved |
|
| Pain in lower abdominal or genital area-Worsened |
|