EUCTR2015-005760-42-GB进行中（未招募）1 期
A Phase IIb multicentre, double-blind, dose-ranging, randomised, placebo-controlled study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 268
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Adult male subject aged 18 to 65 years inclusive
- •2. BMI > 30 kg/m2 and < 50 kg/m2
- •3. Serum total testosterone concentration below the normal range (serum total testosterone < 300 ng/dL [< 10.4 nmol/L]) in both of two morning samples, taken before 11:00 am, at least 3 days apart
- •4. LH levels below the upper limit of normal (ULN)
- •5. Oestradiol levels within or above the normal range of approved assay
- •6. At least two symptoms of androgen deficiency present for at least 2 months prior to the first Screening Visit, with at least one of these being a sexual dysfunction
- •7. Agreement on the part of the subjects to use double-barrier contraception for vaginal sexual intercourse with female partners of child bearing potential to prevent conception and theoretical fetal risk of BGS649 exposure from seminal fluid. To use single barrier protection (condom) to prevent semen exposure through non-vaginal sexual intercourse with female partners of child bearing potential and refrain from sperm donation for the duration of the study. All to be continued for at least 3 months following study drug discontinuation.
- •8. Ability to understand and comply with the requirements of the protocol/study, including understanding and being able to give informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 268
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Evidence of clinically significant endocrinopathy at Screening that may interfere with the study assessments or mask/mimic symptoms of hypogonadism e.g., growth hormone deficiency, adrenal deficiency, untreated hypothyroidism (primary hypothyroidism on replacement with normal thyroid stimulating hormone [TSH] level is allowed), or that may interfere with the evaluation of efficacy/safety parameters
- •2. Other types of HH (e.g., Kallmann syndrome) or primary hypogonadism (e.g., cryptorchidism, or Klinefelter syndrome)
- •3. Any other pituitary or hypothalamic disease, as based on one of the following:
- •- Current or past hypothalamic or pituitary tumour
- •- Suspicion of pituitary or hypothalamic tumour based on a clinical or laboratory evidence, e.g., elevated prolactin or other pituitary hormone abnormality, symptoms/signs of tumour mass effect, very low testosterone and LH (unless there is documentation of a normal magnetic resonance imaging scan of pituitary and hypothalamus within 3 months before first Screening Visit)
- •- Hypothalamic or pituitary conditions, which may contribute to hypogonadism e.g., pituitary sarcoidosis, histiocytosis or tuberculosis
- •4. Subject with prostate disease, as confirmed by the presence of one of the following:
- •- History of prostate cancer
- •- Elevated PSA levels = 3 ng/mL at Screening
- •- Subjects with a detectable prostate nodule or induration at Screening unless proven previously benign by a biopsy
- •- Urologist confirmed symptomatic benign prostatic hyperplasia
- •5. History of type 1 diabetes mellitus
- •6. Current clinical diagnosis of depression or current or past Bipolar disorder
- •7. Uncontrolled type 2 diabetes mellitus (HbA1c > 10.5% at Screening) or significant diabetic neuropathy. Subjects with type 2 diabetes can be included when both of the following conditions are met:
- •- HbA1c = 10.5% at Screening, and:
- •- Anti-diabetic medication regimen (excluding insulin) has been stable for = 8 weeks before the first Screening visit
- •8. Treatment with one or more of the following prescribed or over the counter medications in the six months prior to first Screening Visit:
- •- Medications with known androgenic or estrogenic properties or known to affect production of sex hormones
- •- Injectable testosterone enhancement therapy
- •- Fertility drugs
- •- Growth hormone
- •- Anabolic steroids
- •- Long acting opiates
- •9. Treatment with topical testosterone therapy in the two months prior to first Screening Visit
- •10. Treatment with one of the following medications for either >7 consecutive days in the three months prior to first Screening Visit OR any treatment within 3 weeks of first Screening Visit:
- •- Testosterone lowering drugs e.g., spironolactone, cimetidine, 5a-reductase inhibitors
- •- Short acting opiates / opioids including methadone
- •- Medications known to increase prolactin levels, e.g., antipsychotics
- •11. Treatment with the following medications:
- •- Chronic systemic steroid treatment or systemic steroids for > 5 consecutive days for intercurrent illness within the 4 weeks prior to the first Screening visit (inhaled and topical steroids are allowed)
- •- Clomid within 1 year before first Screening Visit
- •- Biphosphonates or other medication used to treat low bone density (denosumab, teriparatide) except calcium and vitamin D within 1 year before first Screening Visit
- •12. Weight loss or weight gain (gain or loss > 5% body weight) OR weight reduction surgery or procedure within the 3 months prior to first Screenin
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