Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus: A 40 Week Randomized, Double Blind, Placebo Controlled, 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
- 180
- 主要终点
- Change From Baseline in Visual Evaluation of the Vagina
研究概览
简要总结
The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Had an intact uterus
- •Met the inclusion and exclusion criteria for Protocol 15-50310
- •Had completed Protocol 15-50310
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
Treatment Group 1
干预措施: Ospemifene (Dose 1) (Drug)
Treatment Group 2
干预措施: Ospemifene (Dose 2) (Drug)
Treatment Group 3
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Visual Evaluation of the Vagina
时间窗: Baseline to Week 52 (Visit 6)
Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).
Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels
时间窗: Baseline to Week 26 (Visit 5)
Incidence of Adverse Events (AEs)
时间窗: Week 20 (Phone Contact) to Week 56 (Visit 7)
Assessment of Cervical Pap Smear Samples
时间窗: Week 52 (Visit 6)
Cervical Pap smear samples were 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 Endometrial Safety With a Transvaginal Ultrasound (TVU)
时间窗: Baseline to Week 26 (Visit 5)
Mean change in endometrial thickness from baseline
Change From Baseline in Follicle Stimulating Hormone (FSH) Levels
时间窗: Baseline to Week 26 (Visit 5)
Change From Baseline in Testosterone (Free) Levels
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in E2 Levels
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in LH Levels
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in FSH Levels
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in Protein S Ag (Free), P Levels
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in Thromboplastin Time
时间窗: Baseline to Week 52 (Visit 6)
Assessment of Breast Palpation
时间窗: Week 52 (Visit 6)
Breast palpation was done by the investigator to assess abnormalities in the breast.
Change From Baseline in Specific Gravtiy of Urine
时间窗: Baseline to Week 26 (Visit 5)
Mean Percent Change From Baseline in Serum Lipids
时间窗: Baseline to Week 52 (Visit 6)
Assessment of Endometrial Safety With a TVU
时间窗: Baseline to Week 52 (Visit 6)
Mean change in endometrial thickness from baseline
Change From Baseline in Estradiol (E2) Levels
时间窗: Baseline to Week 26 (Visit 5)
Change From Baseline in Luteinizing Hormone (LH) Levels
时间窗: Baseline to Week 26 (Visit 5)
Change From Baseline in Antithrombin Antigen, P Levels
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in Protein C Ag, P Levels
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in Erythrocyte (RBC) Levels
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in Hematocrit Levels
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in pH of Urine
时间窗: Baseline to Week 52 (Visit 6)
Assessment of Hematology Test Values
时间窗: Baseline to Week 52 (Visit 6)
Change from baseline
Change From Baseline in Hemoglobin Levels
时间窗: Baseine to Week 52 (Visit 6)
Assessment of Endometrial Biopsy
时间窗: Week 52 (Visit 6)
Assessments were based on Blaustein's classification.
Mean Change in Blood Chemistry Parameters
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in Testosterone (Total) Levels
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in SHBG Levels
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in Hemogobin Levels
时间窗: Baseline to Week 26 (Visit 5)
Assessment of Mammography
时间窗: Week 52 (Visit 6)
Mammography was done for the detection of characteristic masses and microcalcifications in the breast.
Assessment of Hematology Tests
时间窗: Baseline to Week 26 (Visit 5)
Change from baseline
Change From Baseline in Specific Gravity of Urine
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in Weight
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in DBP
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in Fibrinogen Levels
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in Systolic Blood Pressure (SBP)
时间窗: Baseline to Week 26 (Visit 5)
Change From Baseline in Pulse Rate
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in BMI
时间窗: Baseline to Week 52 (Visit 6)
Change From Baseline in Diastolic Blood Pressure (DBP)
时间窗: Baseline to Week 26 (Visit 5)
Change From Baseline in SBP
时间窗: Baseline to Week 52 (Visit 6)
次要结局
未报告次要终点