NCT02432261已完成1 期
A Randomized, Two Center, Double-Blind Trial to Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Healthy Men
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Gonadotropin Suppression
研究概览
简要总结
This is a prospective, randomized, double-blinded, two-center trial to evaluate the gonadotropin suppressive activity of transdermal treatment with a combined NES/T gel, or T gel alone, for 28 days.
详细描述
A total of 45 subjects will be enrolled and randomized in a 2:1 ratio to one of two treatment groups. A description of each group is as follows:
- Group 1 (30 subjects): 5.0 mL of the 1.62% combined gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders
- Group 2 (15 subjects): 4.4 mL of the 1.62% AndrogelTM (containing 62.7 mg T) applied each day to the arms and shoulders
The total duration of treatment will be 28 days followed by a 72 hour sampling period to assess half-life and a recovery period of at least 28 days, at which point the subjects will return to the clinic for an end of study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening;
- •18 to 50 years of age;
- •BMI < 33 calculated as weight in Kg/(height in cm)2;
- •No history of hormonal therapy use in the last six months prior to the first screening visit;
- •Subject will agree to use a recognized effective method of contraception with his partner (i.e. at a minimum, condom for the male partner and an effective contraception for the female partner) during the course of the study treatment and recovery phase;
- •In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form;
- •Does not meet any of the exclusion criteria.
- •Sperm concentration ≥ 15 million sperm per milliliter ejaculate.
排除标准
- •Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit;
- •Men not living in the catchment's area of the clinic or within a reasonable distance from the site;
- •Clinically significant abnormal physical findings at screening;
- •Elevated PSA (levels ≥ 4 ng/mL), according to local laboratory normal values;
- •Abnormal serum chemistry values, according to local laboratory normal values that indicate liver or kidney dysfunction or that may be considered clinically significant;
- •Use of androgens or body building substances within 6 months before first screening visit;
- •Diastolic blood pressure (DBP) > 80 and/or Systolic (SBP) > 130 mm Hg;
- •EKG abnormal and clinically significant and QTC level longer than 450msec;
- •History of hypertension, including hypertension controlled with treatment;
- •Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis;
- •Known hypersensitivity to progestins or androgen;
- •Family or personal history of venous thromboembolism;
- •Benign or malignant liver tumors; active liver disease;
- •Known history of reproductive dysfunction including vasectomy or infertility;
- •Known history of cardiovascular, renal, hepatic or prostatic disease;
- •A serious systemic disease such as diabetes mellitus or morbid obesity (body weight greater than 120% of ideal body weight or BMI limitation as above);
- •Known or suspected alcoholism or drug abuse that may affect metabolism/transformation of steroid hormones and study treatment compliance;
- •Known dermatitis or severe skin disorder;
- •Moderate or severe depression as determined by PHQ-9 score >15;
- •Partner is known to be pregnant;
- •Known or suspected breast or prostate cancer;
- •Allergic to any ingredient in testosterone/nestorone gel, including alcohol;
- •Known history of untreated sleep apnea;
- •International Prostate Symptom Score (IPSS) greater than or equal to 15.
研究组 & 干预措施
Group 1
Experimental
5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders
干预措施: Nestorone® /testosterone gel (Drug)
Group 2
Experimental
4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders
干预措施: Testosterone only gel (Drug)
结局指标
主要结局
Gonadotropin Suppression
时间窗: 4 weeks
To quantify the gonadotropin suppressive activity of 4 weeks daily therapy of a combination transdermal gel containing 8.3 mg Nestorone® (NES) gel and 62.5 mg (1.62%) testosterone (T) gel, and of T gel (1.62%) alone. Specifically, the proportion (and 95% CI) of men who suppress both gonadotropins (luteinizing hormone \[LH\] and follicle-stimulating hormone \[FSH\]) to ≤ 1 IU/L in each group, will be quantified.
次要结局
- Gonadotropin and Follicle-stimulating Hormone Suppression(4 weeks)
- Change in LH and FSH Concentrations(4 weeks)
- Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations.(4 weeks)
- T Serum Concentrations(8 weeks)
- Secondary Outcome # 6 Part 1a: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hemoglobin)(4 weeks)
- Assessing Sexual Function by Compare Gonadotropin Suppressive Activity of T and NES Against T Alone Through the Psychosexual Daily Questionnaire.(4 weeks)
- Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes(4 weeks)
- Secondary Outcome # 6 Part 5: A Composite Safety of the Combined Gel Determined by Outcomes of Psychosexual Questionnaires(4 weeks)
- Secondary Outcome # 6 Part 3: A Composite Safety of the Combined Gel Determined by Outcomes of Patient Health Questionnaires(4 weeks)
- Secondary Outcome # 6 Part 2a: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry(4 weeks)
- Secondary Outcome # 6 Part 3a: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Blood Pressure)(4 weeks)
- NES Serum Concentrations(8 weeks)
- Secondary Outcome # 6 Part 1b: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (WBC)(4 weeks)
- Secondary Outcome # 6 Part 1c: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hematocrit)(4 weeks)
- Secondary Outcome # 6 Part 2b: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry(4 weeks)
- Secondary Outcome # 6 Part 3b: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Weight)(4 weeks)
研究者
研究点 (2)
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