Study to Investigate the Effect of AB-101 in Breast Cancer Survivors
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in Delayed Orgasm Grade
研究概览
简要总结
The purpose of this research study is to investigate the possibility that a topical drug could restore nipple sensitivity and improve sexual quality of life in breast cancer survivors.
详细描述
Approximately, 80% of breast cancer survivors undergoing will suffer from a permanent reduced reduction in nipple sensitivity and associated lowerdecrease in sexual quality of life. Currently, there are no treatments for restoring nipple sensitivity and the associatedto improve lower sexual quality of life this condition. It would thus be of great clinical benefit to post breast surgery patients if a provide a new safe and , effective , topical , on-demand, treatment for this condition can be developed.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female breast cancer survivor
- •Age: 18 to 70
- •First diagnosed with Stage I or II breast cancer
- •Have had breast surgery: nipple sparring mastectomy or lumpectomy
- •At least 3 years post surgery
- •Nipple neuropathy post breast surgery (change in Llikeart scale >= 3 between pre and post surgery)
- •Baseline nipple sensitivity <=5 (likeartLikert scale)
- •QoL-BC (>=7)
- •Delayed orgasm (CTCAE v4.0) Grade 2
- •One of the following: Delayed orgasm (CTCAE v4.0) Grade 2 and/or Vaginal dryness (CTCAE v4.0) Grade 2 or 3
- •Able to give informed consent
- •Currently in a monogamous heterosexual relationship for at least 12 months
- •Sexually active within the last 30 days
- •Willing to engage in sexual activity at least once a month during the duration of the study
- •Willing to use on a regular basis a web based form system to record sexual events i.e., have access to the Internet
- •Willing to use an adequate method of birth control
- •Able to comply with the study requirements for 8 consecutive weeks
- •Able to give informed consent
排除标准
- •Previous adverse event to alpha 1 agonists (oral, nasal, topical, or ocular) or drugs in this class
- •Currently pregnant
- •Nursing within the last 6 months prior to beginning the study
- •History of cardiovascular or cerebrovascular disease, e.g., heart attack, disease of the arteries of the heart, partial heart block, rapid ventricular heartbeat, slow heartbeat, chronic heart failure, severe hardening of the arteries, blood clot in an artery
- •Actively being treated for breast cancer
- •Changes in chronic medication for oncology, cardiology, or endocrinology in past 12 months
- •Uncontrolled or severe hypertension
- •Decreased oxygen in the tissues or blood
- •Active inflammation of the liver
- •Acute inflammation of the pancreas
- •Overactive thyroid gland
- •Spinal cord injury
- •Nipple dermatitis
- •Regional complex pain syndrome
- •Use of any hypertensive drugs
- •Use of MAO inhibitors
- •Subjects assigned to interventional drug arm and failed to report an increase >=2 from baseline in nipple sensitivity (likert scale) during phase I
- •In partners: sexual dysfunction or erectile dysfunction
- •Currently enrolled in any other medical study or has been enrolled in any medical study in the past 30 days
- •Nipple dermatitis
- •Regional complex pain syndrome
- •Unable to provide consent or make allotted clinical visits
研究组 & 干预措施
AB-101
Apply to both nipple/areola regions approximately 1 hour prior to sexual activity
干预措施: AB-101 (Drug)
Placebo
Apply to both nipple/areola regions approximately 1 hour prior to sexual activity
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Delayed Orgasm Grade
时间窗: [baseline, week 8]
Change in Delayed Orgasm Grade (CTCAE v4.0 - Common Terminology of Adverse Events) CTCAE v4.0 is the NIH Common Terminology of Adverse Events v4.0 Delayed Orgasm is defined as: A disorder characterized by sexual dysfunction characterized by a delay in climax. This is a binary grading system: Grade 0:Delay in achieving orgasm not adversely affecting relationship Grade 1:Delay in achieving orgasm adversely affecting relationship
次要结局
未报告次要终点