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 the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ospemifene 60 mg/day and K-Y® lubricant | Experimental | Subjects will receive a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed. |
|
| Placebo and K-Y® lubricant | Placebo Comparator | Subjects will receive a single, oral dose (1 tablet) of Placebo each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ospemifene 60 mg | Drug | 60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata) | 12 weeks | |
| Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata) | 12 weeks | |
| Change From Baseline to Week 12 in Vaginal pH (Dryness Strata) | 12 weeks | |
| Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | 12 weeks | |
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata) | 12 weeks | |
| Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata) | 12 weeks | |
| Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata) | 12 weeks | |
| Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata) | 4 weeks | |
| Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata) | 4 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
uterine or vaginal prolapse of Grade 2 or higher)
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23361170 | Derived | Portman DJ, Bachmann GA, Simon JA; Ospemifene Study Group. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013 Jun;20(6):623-30. doi: 10.1097/gme.0b013e318279ba64. |
Not provided
Not provided
Subjects reporting moderate to severe VVA symptoms of vaginal dryness or vaginal pain associated with sexual activity as the most bothersome symptom (MBS) at the initial screening visit were allowed to continue in the screening phase of the study. Each subject entered 1 of 2 strata based on their self-reported moderate to severe MBS
First patient was screened on August 04, 2008 and last patient completed on July 30, 2009
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Subjects on Placebo | Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed. |
| FG001 | Subjects on Ospemifene 60 mg/Day | Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Subjects on Placebo | Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed. |
| BG001 | Subjects on Ospemifene 60 mg/Day |
| 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 | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata) | ITT; LOCF | Posted | Mean | Standard Deviation | percentage of parabasal cells | 12 weeks |
|
16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
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 | Subjects on Placebo | Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | MedDRA 10.1 | 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
|
| Placebo | Drug | oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed |
|
| Change From Baseline to Week 4 in Vaginal pH (Dryness Strata) | 4 weeks |
| Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | 4 weeks |
| Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata) | 4 weeks |
| Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | 4 weeks |
| Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata) | 4 weeks |
| Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata) | 4 weeks |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Other-Not mentioned |
|
Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Primary | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata) | ITT; LOCF | Posted | Mean | Standard Deviation | percentage of superficial cells | 12 weeks |
|
|
|
| Primary | Change From Baseline to Week 12 in Vaginal pH (Dryness Strata) | ITT; LOCF | Posted | Mean | Standard Deviation | pH | 12 weeks |
|
|
|
| Secondary | Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata) | ITT | Posted | Mean | Standard Deviation | percentage of parabasal cells | 4 weeks |
|
|
|
| Secondary | Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata) | ITT | Posted | Mean | Standard Deviation | percentage of superficial cells | 4 weeks |
|
|
|
| Primary | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | ITT; LOCF | Posted | Number | participants | 12 weeks |
|
|
|
| Primary | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata) | ITT; LOCF | Posted | Mean | Standard Deviation | percentage of parabasal cells | 12 weeks |
|
|
|
| Primary | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata) | ITT; LOCF | Posted | Mean | Standard Deviation | percentage of superficial cells | 12 weeks |
|
|
|
| Primary | Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata) | ITT; LOCF | Posted | Mean | Standard Deviation | pH | 12 weeks |
|
|
|
| Primary | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | ITT; LOCF | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Change From Baseline to Week 4 in Vaginal pH (Dryness Strata) | ITT | Posted | Mean | Standard Deviation | pH | 4 weeks |
|
|
|
| Secondary | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal dryness associated with sexual activity (dryness strata) was assessed in 152 subjects in the placebo group and 154 subjects in the ospemifene 60 mg/day group. | Posted | Number | participants | 4 weeks |
|
|
|
| Secondary | Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata) | ITT | Posted | Mean | Standard Deviation | pH | 4 weeks |
|
|
|
| Secondary | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal pain associated with sexual activity (dyspareunia strata) was assessed in 287 subjects in the placebo group and 295 subjects in the ospemifene 60 mg/day group. | Posted | Number | participants | 4 weeks |
|
|
|
| Secondary | Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata) | ITT | Posted | Mean | Standard Deviation | percentage of parabasal cells | 4 weeks |
|
|
|
| Secondary | Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata) | ITT | Posted | Mean | Standard Deviation | percentage of superficial cells | 4 weeks |
|
|
|
| 7 |
| 456 |
| 102 |
| 456 |
| EG001 | Subjects on Ospemifene 60 mg/Day | Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed. | 6 | 463 | 153 | 463 |
| Autoimmune Thyroiditis | Endocrine disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hypoparathyroidism | Endocrine disorders | MedDRA 10.1 | Systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Peridiverticular Abscess | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Lung Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Intracranial Aneurysm | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Bipolar Disorder | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Suicide Attempt | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Bladder Prolapse | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Vulvovaginal Candidiasis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Vulvovaginal Mycotic Infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Vaginal Discharge | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA 10.1 | 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 |
| -1 (Sev. to mod., mod.to mild, or mild to none) |
|
| 0 (No change) |
|
| 1 (None to mild, mild to mod., or mod. to sev.) |
|
| -1 (Sev. to mod., mod.to mild, or mild to none) |
|
| 0 (No change) |
|
| 1 (None to mild, mild to mod., or mod. to sev.) |
|
| -1 (Sev. to Mod., Mod. to Mild, or Mild to None) |
|
| 0 (No change) |
|
| 1 (None to Mild, Mild to Mod., or Mod. to Sev.) |
|
| -1 (Sev. to Mod., Mod. to Mild, or Mild to None) |
|
| 0 (No change) |
|
| 1 (None to Mild, Mild to Mod., or Mod. to Sev.) |
|