An Open Label, Escalating Dose, 6 Month Phase III Safety Study Of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 499
- 试验地点
- 25
- 主要终点
- Change From Baseline in BMI
研究概览
简要总结
ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.
详细描述
This study is a phase III, open label safety study with a six month active dosing period. All subjects will be started at 12.5 mg Androxal and titrated to 25 mg if needed. Safety will be assessed by physical and visual acuity exams, slit lamp eye exams, clinical laboratory tests and adverse event reporting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Secondary hypogonadal males between the ages of 18 and 65
- •Men currently using topical testosterone products should wash-out for at least 7 days before Visit
- •All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
- •Previously or concurrently diagnosed as having secondary hypogonadism and confirmed with morning testosterone level < 350 ng/dL for men age < 55 and < 300ng/dl for men age 55-65
- •LH < 15mIU/mL (at Visit 1 only)
- •Ability to complete the study in compliance with the protocol
- •Ability to understand and provide written informed consent.
排除标准
- •Use of an injectable pelleted testosterone within 6 months prior to study (men currently on topical testosterone products may be enrolled in the study after a 7-day washout period).
- •Use testosterone injection, spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
- •Use of Clomid in the past year
- •Uncontrolled hypertension based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study.
- •A hematocrit ≥ 51% or a hemoglobin ≥ 17 g/dL
- •Clinically significant abnormal findings on screening examination, based on the Investigator's assessment.
- •Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication.
- •Known hypersensitivity to Clomid
- •Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade > 2 based on 0-4 scale or any trace of posterior subcapsular cataract)
- •Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study
- •Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, or tumors of the pituitary)
- •Current or history of breast cancer
- •Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA > 3.6
- •Presence or history of known hyperprolactinemia with or without a tumor
- •Chronic use of medications use such as glucocorticoids
- •Chronic use of narcotics
- •Subjects know to be positive for HIV
- •End stage renal disease
- •Subjects with cystic fibrosis (mutation of the CFTR gene)
- •Enrollment in a previous Androxal study
研究组 & 干预措施
Androxal 12.5 mg
Androxal 12.5 mg daily
干预措施: Androxal (Drug)
Androxal 25 mg
Androxal 25 mg daily
干预措施: Androxal (Drug)
结局指标
主要结局
Change From Baseline in BMI
时间窗: 6 months
Mean change from baseline in BMI at end of treatment (26 weeks)
Change From Baseline in LH
时间窗: 6 months
Mean change from baseline in LH at end of treatment (26 weeks)
Absolute Values of Morning Testosterone
时间窗: 6 months
Absolute values of morning testosterone at end of treatment (26 weeks)
Mean Change From Baseline FPG
时间窗: 6 months
Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)
Change From Baseline in Total Morning Testosterone at 26 Weeks
时间窗: 6 months
Changes in values from baseline of total morning testosterone levels at Week 26
Change From Baseline in FSH
时间窗: 6 months
Change from baseline in FSH at end of treatment (26 weeks)
次要结局
未报告次要终点