A Double-Blind Extension Study to Evaluate the Post-Treatment Safety and Duration of Clinical Effect of LIPO-202 in Subjects Who Completed Either the LIPO-202-CL-18 or LIPO-202-CL-19 Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Evofem Inc.
- 入组人数
- 100
- 主要终点
- Evaluation of a 12-month Post-treatment, Non-interventional, Observational Period to Evaluate the Safety and Duration of Clinical Effects of LIPO-202.
研究概览
简要总结
LIPO-202-CL-23 is a follow-on study to evaluate the post-treatment safety and duration of clinical effect of LIPO-202 in subjects that completed either the LIPO-202-CL-18 (NCT02397499) or LIPO-202-CL-19 (NCT02398188). No risks related to treatment are anticipated as subjects will not receive additional treatment with LIPO-202 or Placebo for LIPO-202 in this follow-on study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male or non-pregnant female subjects who completed Study LIPO-202-CL-18 or LIPO-202-CL-19
- •Capable of providing written consent
- •Willing to comply with the study procedures and schedule
排除标准
- •Female subjects who are pregnant or are not using adequate birth control methods
- •Plan on starting a weight loss or exercise program during the study
- •Plan to enroll in another investigational drug or device study
- •Unlikely or unable to adhere to the study visit schedule
研究组 & 干预措施
Experimental: LIPO-202
Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study.
干预措施: LIPO-202 (Drug)
Placebo Comparator: Placebo
Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study.
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of a 12-month Post-treatment, Non-interventional, Observational Period to Evaluate the Safety and Duration of Clinical Effects of LIPO-202.
时间窗: 1 Year
Subjects who report an improvement of a least 1-point (grade) on the patient global abdominal perception scale and the photonumeric scale.
Evaluation of the Post-treatment Duration of Clinical Effect of LIPO-202. Photonumeric Score and Global Abdominal Perception Score.
时间窗: 1 Year
Measured by change in clinician reported photonumeric score and change in patient reported global abdominal perception score. Patient-rated changes in amount of bulging or flatness of their belly using the 5-point scale provided as pictures where zero is flat and five is big bulge.
次要结局
未报告次要终点