Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus

Study Overview
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Brief Summary
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The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.

Official Title
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Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus: A 52-Week Open-Label Follow-Up to Protocol 15-50310

Conditions
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Atrophy, Vaginal Diseases

Intervention / Treatment
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* Drug: Ospemifene 60Mg Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women aged 40 to 80 years with a diagnosis of vulvar and vaginal atrophy (VVA) as assessed by vaginal pH, maturation index of vaginal smear, and self-reported symptoms at Baseline for Protocol 15-50310 Did not have a uterus Met the inclusion and exclusion criteria for Protocol 15-50310 Had completed Protocol 15-50310 without any clinically significant abnormal findings at the end-of-study visit for Protocol 15-50310 Provided written informed consent to participate in the study and agreed to follow dosing instructions and complete all required study visits Exclusion Criteria: Had clinically significant abnormal findings at the Week 12 End of Study visit for Protocol 15-50310 Had any physical or mental condition which, in the opinion of the investigator, may have interfered with the subject's ability to comply with the study procedures

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ospemifene 60 mg Oral Tablet<br>Participants will take one tablet of ospemifene 60 mg orally, once a day for 12 weeks. | Drug: Ospemifene 60Mg Oral Tablet<br> <br> * Other names: Osphena®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Testosterone Levels at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in E2 Levels at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in FSH and LH Levels at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in SHBG Levels at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in Testosterone Levels at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Incidence of Adverse Events (AEs) |  | Week 13 (Phone Contact) to Week 56 (Visit 4) | 
| Change From Baseline in Serum Lipid Levels at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Serum Lipid Levels at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in Blood Pressure at Visit 2 | Systolic blood pressure (SBP), diastolic blood pressure (DBP) | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Pulse Rate at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Weight at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Body Mass Index (BMI) at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Blood Pressure at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in Pulse Rate at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in Weight at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in BMI at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in Visual Evaluation of Vagina at Visit 2 | Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe) | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Visual Evaluation of Vagina at Visit 3 | Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe) | Baseline to Week 52 (Visit 3) | 
| Assessment of Cervical Pap Smear Samples (if Cervix is Intact) | Cervical Pap smear samples are used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells. | Week 52 (Visit 3) | 
| Assessment of Breast Palpation at Visit 2 | Breast palpation was used to assess breast abnormalities. | Week 26 (Visit 2) | 
| Assessment of Breast Palpation at Visit 3 | Breast palpation was used to assess breast abnormalities. | Week 52 (Visit 3) | 
| Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Erythrocyte Levels at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Hemoglobin Levels at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in Erythrocyte Levels at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in Hemoglobin Levels at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in MCV and MPV at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in Albumin and Total Protein Levels at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Albumin and Total Protein Levels at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in ALT, AST and CK Levels at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in pH of Urine at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in Specific Gravity of Urine at Visit 2 |  | Baseline to Week 26 (Visit 2) | 
| Change From Baseline in pH of Urine at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in Specific Gravity of Urine at Visit 3 |  | Baseline to Week 52 (Visit 3) | 
| Change From Baseline in Estradiol (E2) Levels at Visit 2 |  | Baseline to Week 26 (Visit 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopausal symptoms, Vulvar and vaginal atrophy in menopausal women, Vaginal atrophy, Urogenital atrophy