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| Name | Class |
|---|---|
| Hormos Medical | INDUSTRY |
| QuatRx Pharmaceuticals | INDUSTRY |
The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ospemifene 60 mg/day | Experimental | Ospemifene will be taken orally, once daily, in the morning, with food for 52 weeks. |
|
| Placebo | Placebo Comparator | Placebo will be taken once daily, in the morning, with food for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ospemifene 60 mg | Drug | 60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear | 12 weeks | |
| Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of Vaginal Smear | 12 weeks | |
| Mean Change From Baseline in Vaginal pH | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Estradiol Levels | 52 weeks | |
| Change From Baseline in Luteinizing Hormone Levels | 52 weeks | |
| Change From Baseline in Follicle Stimulating Hormone Levels |
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Inclusion Criteria:
Exclusion Criteria:
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This was a multicenter study conducted at 23 centers in Belgium, Denmark, Finland, and Sweden. First subject was screened on Nov. 26, 2007 and last subjected completed the study on June 26, 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects on Placebo (Baseline) | Placebo was taken orally, once daily, in the morning, with food for 52 weeks. |
| FG001 | Subjects on Ospemifene 60 mg/Day (Baseline) | Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects on Ospemifene 60 mg/Day (Baseline) | Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks. |
| BG001 | Subjects on Placebo (Baseline) | Placebo was taken orally, once daily, in the 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 | Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear | ITT | Posted | Mean | Standard Deviation | percentage of parabasal cells | 12 weeks |
|
|
16 Weeks; From the signing of the informed consent form to the last safety evaluation (Week 12)
Safety data were reported in the safety population, which included all treated subjects according to the treatment they actually received.
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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 | Subjects on Placebo (Baseline) | Placebo was taken orally, once daily, in the morning, with food for 52 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seronegative Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shionogi Clinical Trials Administrator | Shionogi Inc. | 800-849-9707 | Shionogiclintrials-admin@shionogi.co.jp |
| 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 |
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|
|
| Placebo | Drug | Dosing will be oral and placebo will be taken once daily, in the morning, with food for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52) |
|
| 52 weeks |
| Change From Baseline in Sex Hormone Binding Globulin Levels | 52 weeks |
| Visual Evaluation of the Vagina (Baseline & Week 52) | 52 weeks |
| Protocol Violation |
|
| Lost to Follow-up |
|
| Other-family problems & doctor's request |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | Participants |
|
| Alcohol | Mean | Standard Deviation | drinks/week |
|
| Alcohol | Mean | Full Range | drinks/week |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| BMI | Mean | Full Range | kg/m^2 |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of Vaginal Smear | ITT | Posted | Mean | Standard Deviation | percentage of superficial cells | 12 weeks |
|
|
|
| Primary | Mean Change From Baseline in Vaginal pH | ITT | Posted | Mean | Standard Deviation | pH | 12 weeks |
|
|
|
| Secondary | Change From Baseline in Estradiol Levels | ITT | Posted | Mean | Standard Deviation | nmol/L | 52 weeks |
|
|
|
| Secondary | Change From Baseline in Luteinizing Hormone Levels | ITT | Posted | Mean | Standard Deviation | U/L | 52 weeks |
|
|
|
| Secondary | Change From Baseline in Follicle Stimulating Hormone Levels | ITT | Posted | Mean | Standard Deviation | U/L | 52 weeks |
|
|
|
| Secondary | Change From Baseline in Sex Hormone Binding Globulin Levels | ITT | Posted | Mean | Standard Deviation | nmol/L | 52 weeks |
|
|
|
| Secondary | Visual Evaluation of the Vagina (Baseline & Week 52) | ITT | Posted | Number | participants | 52 weeks |
|
|
|
| 4 |
| 62 |
| 37 |
| 62 |
| EG001 | Subjects on Ospemifene 60 mg/Day (Baseline) | Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks. | 18 | 364 | 252 | 364 |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac ablation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Breast cosmetic surgery | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Carpel tunnel decompression | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Blepharoplasty | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ovarian cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Burns third degree | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Global amnesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mesothelioma malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Arthrodesis | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Multiple myeloma | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Influenza Like Illness | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Vulvovaginal Candidiasis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Tract Infection Bacterial | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Tract Infection Staphylococcal | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Asymptomatic Bacteriuria | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vaginal Discharge | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vulvovaginal Dryness | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Genital Discharge | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA 10.0 | 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-Mild |
|
| Friability-Moderate |
|
| Friability-Severe |
|
| Pallor-None |
|
| Pallor-Mild |
|
| Pallor-Moderate |
|
| Pallor-Severe |
|
| Petechiae-None |
|
| Petechiae-Mild |
|
| Petechiae-Moderate |
|
| Petechiae-Severe |
|
| Vaginal dryness in the mucosa-None |
|
| Vaginal dryness in the mucosa-Mild |
|
| Vaginal dryness in the mucosa-Moderate |
|
| Vaginal dryness in the mucosa-Severe |
|
| Vaginal redness in the mucosa-None |
|
| Vaginal redness in the mucosa-Mild |
|
| Vaginal redness in the mucosa-Moderate |
|
| Vaginal redness in the mucosa-Severe |
|