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
- Registration Number
- NCT01586364
- Lead Sponsor
- Shionogi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 301
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ospemifene 60 mg Oral Tablet Ospemifene 60Mg Oral Tablet Participants will take one tablet of ospemifene 60 mg orally, once a day for 12 weeks.
- Primary Outcome Measures
Name Time Method 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 Baseline to Week 26 (Visit 2) Systolic blood pressure (SBP), diastolic blood pressure (DBP)
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 Baseline to Week 26 (Visit 2) Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)
Change From Baseline in Visual Evaluation of Vagina at Visit 3 Baseline to Week 52 (Visit 3) Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)
Assessment of Cervical Pap Smear Samples (if Cervix is Intact) Week 52 (Visit 3) 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.
Assessment of Breast Palpation at Visit 2 Week 26 (Visit 2) Breast palpation was used to assess breast abnormalities.
Assessment of Breast Palpation at Visit 3 Week 52 (Visit 3) Breast palpation was used to assess breast abnormalities.
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 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 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 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) 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)
- Secondary Outcome Measures
Name Time Method