An open label, multi-center, prospective clinical study to Evaluation of Efficacy and Safety of JPF-16 Capsules in Sexual Dysfunction in Females
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in sexual feelings and responses [assessment using Female Sexual Function Index (FSFI)]
研究概览
简要总结
Itis an open label, interventional, multi-center, prospective clinical study toevaluate efficacy and safety of ‘JPF-16 Capsule’ in 38 female patientssuffering from sexual dysfunction. The study will be conducted at two sites inIndia. The dose of the drug would be 2 capsules two times daily orally aftermeals for 4 weeks. The primary outcome measures will be to assess efficacy of ‘JPF-16Capsule’ on sexual feelings and responses [assessment using Female Sexual FunctionIndex (FSFI)] on day -7, day 0, day, 14 and day 28. The secondary outcomes willbe assessment of Global assessment for overall improvement by the investigatorand by the patient at the end of the study treatment, assessment oftolerability of study drug by assessing adverse events and assessment oflaboratory parameters on day -7, day 0, day 14 and day 28
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 19.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Diagnosis of Female Sexual Interest/Arousal Disorder according to the DSM-5 criteria (2013)
- •Be involved in a stable relationship and have a partner
- •Healthy according to normal results of medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant.
排除标准
- •1.Subjects with major illnesses and sexual dysfunction due to anatomical, surgical or pharmacological causes 2.Subjects with history of major psychiatric disorder 3.Subjects with history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery 4.Subjects with hypotension or uncontrolled hypertension, uncontrolled diabetes, hepatic impairment, renal impairment or hematological disorders.
结局指标
主要结局
Changes in sexual feelings and responses [assessment using Female Sexual Function Index (FSFI)]
时间窗: Day -7, Day 0, Day 14 and Day 28
次要结局
- 1. Global assessment for overall improvement by the patient at the end of the study treatment.(2. Global assessment for overall improvement by the investigator at the end of the study treatment.)