A 6 Month, Double-blind Safety Extension Study of MBGS205
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Percent Change in Bone Mineral Density Measured by DEXA (g/cm^2) From Baseline in Study MBGS205 to Week 48 in Study MBGS206
研究概览
简要总结
Phase IIb, multicentre, double-blind, randomised, placebo-controlled parallel-group 36-week study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism (HH)
详细描述
This is a 6 months, active treatment, extension study, open to subjects who have completed full 24 weeks in Study MBGS205 (A Phase IIb multicentre, double-blind, dose-ranging, randomised, placebo-controlled study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism [HH]).The main purpose of Study MBGS206 is to evaluate long term safety and efficacy parameters in subjects after 12 months exposure with BGS649.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participating in Study MBGS205 and completion of the 24 week treatment period without meeting any discontinuation criteria of Study MBGS205
- •In opinion of the investigator has been compliant with the requirements of the Study MBGS205 protocol.
排除标准
- •Meeting any of the discontinuation criteria of initial Study MBGS205
研究组 & 干预措施
BGS649 0.1 mg
Drug: BGS649 Dose 1 weekly
干预措施: BGS649 (Drug)
BGS649 0.3 mg
Drug: BGS649 Dose 2 weekly
干预措施: BGS649 (Drug)
BGS649 1.0 mg
Drug: BGS649 Dose 3 weekly
干预措施: BGS649 (Drug)
结局指标
主要结局
Percent Change in Bone Mineral Density Measured by DEXA (g/cm^2) From Baseline in Study MBGS205 to Week 48 in Study MBGS206
时间窗: At 48 weeks compared to baseline in MBGS205
Percentage change in lumbar bone mineral density measured by DEXA (g/cm\^2) from Baseline in Study MBGS205 to Week 48 in Study MBGS206 by dose group in participants randomised to active treatment in MBGS205.
次要结局
- Percentage Change From Baseline in DEXA Scan Density (g/cm^2) by Location for Subjects Randomised to Active Treatment in Study MBGS205 (Over-read)(48 Weeks)
- Descriptive Summary of Percentage Change in Bone Turnover Markers for Subjects Randomised to Active Treatment in Study MBGS205(48 Weeks)
- Percentage of Subjects With DEXA Scan T-score ≤ -2.5 at Week 48 by Location(48 Weeks)
- Percentage Change From Baseline in Bone Mineral Density by Location and Vitamin D Deficiency(48 Weeks)
- Change From Baseline of Oestradiol (Absolute) From Baseline in Study MBGS205 to Week 48(48 Weeks)
- Change From Baseline of Oestradiol (Percentage) From Baseline in Study MBGS205 to Week 48(48 Weeks)
- Analysis of Proportion of Subjects That Overshoot Testosterone for Subjects Randomised to Active Treatment in Study MBGS205(48 Weeks)
- Change From Baseline in PSA From Baseline in Study MBGS205 to Week 48 in Study MBGS206(48 Weeks)
- Change From Baseline in Haematocrit at Week 48(48 Weeks)
- Change From Baseline in Blood Pressure From Baseline to Week 48MBGS205(48 Weeks)
- Percentage of Subjects Achieving Normalisation of Bioavailable (Total) Testosterone at Wk 48(48 Weeks)
- Change From Baseline in Free and Bioavailable Testosterone(48 Weeks)
- Change From Baseline in Luteinizing Hormone From Baseline to Week 48(48 Weeks)
- Change From Baseline in Follicle Stimulating Hormone at Week 48(48 Weeks)
- Percentage Change in Bone Alkaline Phosphatase(48 weeks)
- Descriptive Summary of Total Testosterone (ng/dL) for Subjects Randomised to Active Treatment in Study MBGS205(48 Weeks)