Hypoactive Sexual Desire Disorder in Males (10-18-40-13)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mohit Khera
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Sexual Desires Inventory-2 (SDI-2)
研究概览
简要总结
The purpose of this study is to determine if the study drug will increase sexual desire in men with HSDD. Half of the participants will take ADDYI while the other half will receive a placebo (a look-alike pill with no medicine).
详细描述
This pilot randomized placebo controlled study will include 60 men (30 treatment and 30 placebo). ARM 1 will take flibanserin 100mg orally every night and ARM 2 will take a placebo orally every night.
There will be four study visits and the study duration is approximately 4 months. Participants will have physicals at each visit. Blood draws for tests will be done at 3 visits and up to 4 questionnaires will completed at each visit. Study drug will randomized.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Study medication (flibanserin 100 mg or identically matched placebo) will be provided in a randomized fashion. Randomization will be 1:1 with a block size of 4. Each individual kit will contain three bottles of 30 tablets of study medication. Each individual bottle within the kit will be labeled sequentially, for example kit 201 will include three bottles of 30 tablets labeled 201A, 201B, 201C. Kits will be numbered consecutively in the randomized order. Once a patient is confirmed eligible to participate in the study, the site will select the lowest numbered kit that has not been assigned to a subject. Subjects will be provided with the "A" bottle at their first visit. The site will mark the subject's study number on the kit and document which subject received that kit number. As subjects return for interim visits, they will be provided the "B" and "C" bottles from their previously assigned kit.
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men age 18 through 69 years old
- •Men who are distressed by their low libido as defined by SDI-2, and SCI-M questionnaires. (Appendices A,C)
- •Men who are not depressed as defined by PHQ-9 (Patient Health Questionnaire) score of 9 or less. (Appendix D)
- •Men with good erectile function as defined by IIEF greater than 22
- •Men with normal testosterone and liver function values (may be on testosterone therapy)
- •Men who are satisfied in their relationship or with their partners
- •Men or their female partners must be willing to use one form of contraception throughout the study and 30 days after final study visit.
- •Willing to give informed consent
排除标准
- •Hypogonadal patients (less than 350 ng/dL)
- •IIEF-EF less than 22
- •CYP3A4 and CYP2C19 inhibitors Use of moderate or strong CYP3A4 inhibitors is prohibited for the duration of the trial, and if such medication becomes necessary, flibanserin treatment must be suspended until 2 weeks after the last dose of the CYP3A4 inhibitor
- •Hepatic impairment not greater than 1.5 upper limit of normal of AST/ALT
- •Men with normal to high libido
- •Depressed patients as assessed by the PHQ-9 questionnaire as defined as 10 or greater.
- •Men who are stressed or fatigued as determined by the PI
- •Men with partners who have low libido as determined by the PI
- •Men with pre-existing conditions that might predispose to hypertension
- •Men who are not willing to meet the requirements for drinking alcohol during their participation in the study
- •Men who are taking digoxin
研究组 & 干预措施
Arm 1 - Active
Participants will take flibanserin 100mg orally every night for approximately 3 months.
干预措施: Flibanserin (Drug)
Arm 2 - Placebo
Participants will take a placebo orally every night for approximately 3 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Sexual Desires Inventory-2 (SDI-2)
时间窗: 3 months
Range 2-10: Number of Participants with a significant change of at least 2 points higher than at screening.
Patient Health Questionnaire (PHQ-9)
时间窗: 3 months
Number of Participant with a significant change of at least 2 points on the PHQ-2 questionnaire after 3 months
次要结局
- Sexual Concerns Inventory - Male (SCI-M) questionnaire(3 months)
- Erectile Function Change(3 months)
研究者
Mohit Khera
Professor of Urology
Baylor College of Medicine