An Open-Label, Nine-Month Randomized Controlled Study of Testosterone (Testopel) Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- penile curvature
研究概览
简要总结
Two recent studies have identified low levels of serum testosterone in association with Peyronie's Disease (PD), with a significant correlation noted between severity of testosterone deficiency and severity of curvature. The study hypothesis is to determine whether treatment with testosterone may help men with PD and penile curvature.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •acquired penile curvature of > 30 degrees and < 90 degrees associated with palpable penile plaque on physical examination
- •onset of curvature within 18 months prior to signing consent form
- •serum TT < 500 ng/dl at the screening visit
排除标准
- •prior history of treatment for PD that includes intra-lesional injections, topical creams, or surgery
- •prior treatment with oral therapy at least 2 weeks prior to signing consent form (e.g. Potaba, Vitamin E, colchicines) will be acceptable for inclusion
- •prior history of treatment for testosterone deficiency
- •presence of dense calcified plaque by US or plain radiograph
- •taking the medication Coumadin
- •hypersensitivity to testosterone, stearic acid, or polyvinyl pyrolidone (the constituents of Testopel)
- •unable to achieve adequate erection with penile injection to access degree of curvature
- •undergone definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, cryotherapy.
- •prior history of prostate cancer, hematologic disorders, chronic liver disease including cirrhosis and hepatitis C, disorders affecting the immune system, including infection with human immunodeficiency virus, or psychiatric disorders including major depression, schizophrenia, bipolar disease
- •history of cerebrovascular accident, history of deep venous thrombosis within the past 5 years or history of untreated or severe sleep apnea
- •PSA > 4.0 ng/dL at the screening visit, unless prostate cancer has been excluded to the investigator's satisfaction
- •clinically significant abnormal lab results that would put the subject at increased risk or compromise the integrity of the study data, in the opinion of the investigator
- •received any other investigational drug within 30 days
研究组 & 干预措施
Vitamin D and E
Oral Vitamin D and E alone in men with penile curvature due to PD.
干预措施: Vitamin D2 (Drug)
Vitamin D and E
Oral Vitamin D and E alone in men with penile curvature due to PD.
干预措施: Vitamin E (Drug)
Testosterone Pellets and Vitamin D and E
Testosterone in combination with oral Vitamin D an E supplementation in men with penile curvature due to PD.
干预措施: Testosterone Pellets (Drug)
结局指标
主要结局
penile curvature
时间窗: 9 months
The primary outcome to be assessed will be the change in penile curvature from baseline.
次要结局
- sexual function(9 months)
研究者
Dr. Abraham Morgentaler
Associate Clinical Professor of Urology Harvard Medical School
Men's Health Boston