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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 301
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ospemifene 60 mg Oral Tablet
Participants will take one tablet of ospemifene 60 mg orally, once a day for 12 weeks.
干预措施: Ospemifene 60Mg Oral Tablet (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: Week 13 (Phone Contact) to Week 56 (Visit 4)
Change From Baseline in Serum Lipid Levels at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Serum Lipid Levels at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in Blood Pressure at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Systolic blood pressure (SBP), diastolic blood pressure (DBP)
Change From Baseline in Pulse Rate at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Weight at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Body Mass Index (BMI) at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Blood Pressure at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in Pulse Rate at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in Weight at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in BMI at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in Visual Evaluation of Vagina at Visit 2
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: Week 26 (Visit 2)
Breast palpation was used to assess breast abnormalities.
Assessment of Breast Palpation at Visit 3
时间窗: 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
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Erythrocyte Levels at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Hemoglobin Levels at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in pH of Urine at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in Erythrocyte Levels at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in Hemoglobin Levels at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in MCV and MPV at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in Albumin and Total Protein Levels at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Albumin and Total Protein Levels at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in ALT, AST and CK Levels at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in Specific Gravity of Urine at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in pH of Urine at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in Specific Gravity of Urine at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in Estradiol (E2) Levels at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in Testosterone Levels at Visit 2
时间窗: Baseline to Week 26 (Visit 2)
Change From Baseline in E2 Levels at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in FSH and LH Levels at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in SHBG Levels at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
Change From Baseline in Testosterone Levels at Visit 3
时间窗: Baseline to Week 52 (Visit 3)
次要结局
未报告次要终点