A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Minocycline Extended-Release Tablets on Spermatogenesis in Human Males
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 10
- 主要终点
- Mean Percent Change From Screening in Sperm Concentration.
研究概览
简要总结
Researchers want to find out how Minocycline Extended-Release Tablets affect sperm-production in healthy males.
The study will include Minocycline Extended-Release Tablets, a new once-daily formulation of minocycline, compared with a placebo or inactive pill.
Approximately 170 healthy adult males will be assigned by chance (like flipping a coin) to 2 treatment groups with approximately 85 subjects per group. You will be treated with either Minocycline Extended-Release Tablets or placebo once daily. Screening will occur within 14 days prior to the first dose of study drug.
Required study activities include:
- Written informed consent
- Weight
- Two semen collections within 48-72 hours of one another at the screening visit and Days 84,112, 140, and 168
- Blood draws at the screening visit and Days 84, 112, 140, and 168
- Genital examination (excluding prostate) at screening and at the Day 84 and Day 112 visits
- Medical history
You will continue in the treatment phase of the study for 12 weeks.
You will return to the clinic 4 weeks and 8 weeks after completion of the treatment phase of the study, with the final study visit approximately 12 weeks after the last dose.
Participation will be for 24-weeks.
Up to 10 investigational sites will enroll subjects into the study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males at least 18 years of age
- •Weight 45 kg - 136.36 kg (99-300 lbs)
- •Must understand and give consent voluntarily to be in the study and to comply with study requirements
- •Subjects must ejaculate between 48 and 72 hours prior to collection of the first specimen (Pre-Collection Ejaculation) and refrain from further ejaculation until Specimen 1 is collected. The second ejaculation sample Specimen 2) must be collected between 48 hours and 72 hours after Specimen
- •No ejaculation is permitted between Specimen 1 and Specimen 2
- •Must refrain from using saunas or hot tubs during the duration of the study 168 days)
- •Must be a non smoker
- •Must be medically healthy as determined by the investigator physician (via medical history and clinical laboratory tests)
- •Must have sperm parameters (average of Specimen 1 and Specimen 2) within clinically acceptable limits at screening defined as:
- •Total sperm concentration ≥20 x 106/mL10
- •% motile ≥50%10
- •% normal morphology >4.4%14
排除标准
- •Known allergy/sensitivity to minocycline or any of the other drug product components
- •Use of antacids or other dietary supplements containing aluminum, calcium, iron, or magnesium
- •History of vestibular incidents including vertigo, lightheadedness, nausea, or vomiting within the 30 days prior to enrollment
- •Known history of alcohol or drug dependency, significant within the past 2 years
- •Known history or current risk of hepatic dysfunction
- •Known history or current risk of renal dysfunction, e.g., uncontrolled diabetes
- •Systemic lupus erythematosis (SLE) or a positive ANA at screening
- •Receipt of any experimental drugs within 120 days prior to Study Day 0
- •Non-LFT clinical laboratory values outside the normal range and determined to be of clinical significance
- •Liver function tests greater than 1.5 times the upper limit of normal (ALT, AST, GGT)
- •Use of tetracyclines, erythromycin within 12 weeks of Day 0
研究组 & 干预措施
Minocycline Extended-Release Tablets
干预措施: minocycline extended release (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Percent Change From Screening in Sperm Concentration.
时间窗: Baseline and 12 Weeks
次要结局
未报告次要终点