EUCTR2004-001545-15-IE进行中（未招募）1 期
Multicenter, double blind, randomized, placebo controlled study of Testogel® (testosterone 50–100mg) to evaluate its efficacy and safety in men presenting with typical symptoms of partial androgen deficiency of aging males (PADAM) over a period of 6 months with 12 months open label follow-up - European Testogel study in PADAM
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Schering AG
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.Men aged 50 to 80 inclusive
- •2.Symptomatic hypogonadism as defined by i and ii:
- •i.Total testosterone <15nmol/l (<4.3ng/ml), bioavailable testosterone will be calculated9 from total testosterone and sex hormone binding globulin and must be <4.43nmol/l (<1.28ng/ml)
- •ii.Aging males’ symptom score >36
- •3.Willing to avoid significant change in the pattern of physical exercise and lifestyle for the duration of the study
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Use of androgen therapy or anabolic steroids within 12 months of entry into the study (i.e. screening visit/visit 1)
- •2.Contraindication to treatment with Testogel® according to the SPC
- •3.Hypersensitivity to the active substances or any of the excipients of Testogel®
- •4.Extensive skin abnormalities that could affect absorption of the gel
- •5.Diagnosed sleep apnea
- •6.Polycythemia
- •7.Hematocrit >50% at entry to the study (i.e. screening visit/visit 1)
- •8.Prolactin >25ng/ml
- •9.Organic hypothalamic-pituitary pathology
- •10.Severe psychiatric disease
- •11.Prostate specific antigen (PSA) =4ng/ml
- •12.Severe symptomatic benign prostatic hyperplasia (IPSS sum score =20)
- •13.Concurrent use of androgens including dehydroepiandrosterone (DHEA), anabolic steroids, clomipramine, antiandrogens, estrogen, cytochrome P450 inducing medicines (e.g. quinidine, ketoconazole, macrolides), corticotrophins (ACTH), oxyphenbutazone
- •14.Body mass index >35kg/m2
- •15.Uncontrolled thyroid disorders
- •16.Diabetes mellitus with vascular changes, or which is uncontrolled
- •17.Epilepsy not adequately controlled by treatment
- •18.Patients requiring fertility treatment
- •19.Any clinically significant chronic disease that might, in the opinion of the investigator, compromise patient’s safety interfere with the evaluations, or preclude completion of the trial (e.g. hemochromatosis, chronic lung disease, chronic malabsorption disease)
- •20.History of alcohol or drug abuse
- •21.Medical, psychiatric or other conditions that compromise the patient’s ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study.
- •22.Hypertension which is not adequately controlled on therapy
- •23.Severe cardiac, hepatic or renal insufficiency
- •24.Suspicion of, current, or past history of prostate or breast cancer
- •25.Metal implants in the body (metal implants in the head will not exclude patients from participation)
- •26.Previous randomization into this study
- •27.Concurrent participation in another clinical trial within 1 month of entry into this study (i.e. screening visit/visit 1) or throughout the duration of the study.
研究者
相似试验
进行中（未招募）
不适用
Randomized, multicenter, double blind, placebo controlled trial, for the evaluation of the efficacy and tolerability of ursodeoxycholic acid on the dissolution of cholesterol gallstones (<15mm) after 18 months of therapyRandomized multicenter double blind, placebo controlled trial, for the evaluation of the efficacy and tolerability of UDCA on the dissolution of cholesterol gallstones (<15mm) after 18 months of therapy.EUCTR2005-005919-24-HUDr. Falk Pharma Portugal224
进行中（未招募）
不适用
Multicenter, double-blind, randomized, placebo controlled, dose ranging phase 2 study to investigate efficacy, safety, tolerability and pharmacokinetics of the DPP-IV inhibitor RO0730699 in patients with type 2 diabetes, who are treated with a stable dose of metformin BM18106type 2 diabetesMedDRA version: 6.1Level: PTClassification code 10049746EUCTR2004-004529-84-ITROCHE200
进行中（未招募）
不适用
Multicenter, double-blind, randomized, placebo controlled, dose ranging phase 2 study to investigate efficacy, safety, tolerability and pharmacokinetics of the DPP-IV inhibitor RO0730699 in patients with type 2 diabetes, who are treated with a stable dose of metformiEUCTR2004-004529-84-DEF. Hoffmann-La Roche Ltd200
进行中（未招募）
不适用
Multicentre, randomised, double blind, placebo controlled study on long-term treatment with Sulodexide for prevention of recurrent DVT in patients with venous thromboembolism - SURVET studyEUCTR2009-016923-77-ITALFA WASSERMA784
进行中（未招募）
不适用
Multicentre, randomised, double blind, placebo controlled study on long-term treatment with Sulodexide for prevention of recurrent DVT in patients with venous thromboembolism - SURVETVenous ThromboembolismMedDRA version: 14.0Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 10047065 - Vascular disordersEUCTR2009-016923-77-PLAlfa Wassermann SpA784