PER-063-10已完成未知
A STUDY OF THE EFFICACY AND SAFETY OF MULTIPLE DOSES OF DUTASTERIDE VERSUS PLACEBO AND FINASTERIDE IN THE TREATMENT OF MALE SUBJECTS WITH ANDROGENETIC ALOPECIA
GLAXOSMITHKLINE PERU S.A.,0 个研究点目标入组 103 人开始时间: 2010年11月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 103
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 至 50（—）
- 性别
- Male
入选标准
- •Outpatient male patient, 20 to 50 years of age inclusive.
- •AGA classified as Types III (vertex), IV, or V (excluding the above Type IV and V) using the Norwood-Hamilton classification (see Appendix 1)
- •Read and write fluently in the local language, with the ability to understand and record information on the hair growth index (HGI) questionnaires, the Hair Growth Satisfaction Scale (HGSS) and the Evaluation Scale of problem of the inventory of sexual function (FAS SFI).
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2x normal upper limit (ULN); alkaline phosphatase and bilirubin <1.5xLLN (an isolated bilirubin> 1.5xULN is acceptable if bilirubin is fixed and direct bilirubin is <35%).
- •Is willing to meet the requirements of the study, including maintaining the same hairstyle and hair color throughout the study.
排除标准
- •Evidence of hypogonadism defined as serum testosterone <250 ng / dL in the selection.
- •Unstable liver disease (stable chronic hepatitis B and C evidence is acceptable, if the subject meets the other admission criteria).
- •Serum creatinine> 1.5xULN in the selection.
- •History of malignant neoplasia in the last 5 years, with the exception of basal cell or squamous cell carcinoma of the skin.
- •History of prostate cancer in a first-degree relative before the age of 50.
- •Serum levels of specific prosthetic antigen (PSA)> 2.0 ng / mL in the selection.
- •History of breast cancer or clinical breast exam suggestive of malignant neoplasia.
- •Active and unstable thyroid disease, including subjects under treatment for either hyperthyroidism or hypothyroidism, unless the doses of thyroid medications have remained stable for at least 3 months.
- •Any serious and unstable coexisting medical condition including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, stroke in the 6 months prior to selection, uncontrolled diabetes , peptic ulcer that is not controlled by medical management, and subjects known to be positive for human immunodeficiency virus (HIV) (including subjects with acquired immunodeficiency syndrome [AIDS]).
- •Background or current evidence of any medical condition or pre-existing serious and / or unstable psychiatric disorder, or other conditions that, in the opinion of the investigator or the GlaxoSmithKline (GSK) medical monitor, could interfere with the patient´s safety, with the obtaining informed consent, or with compliance with the study procedures.
- •Global thinning of scalp hair, including occipital areas.
- •Scars of the scalp, including previous hair transplantation or reduction of the scalp, or any other condition or disease of the scalp or hair, including diseases of the hair shaft (for example, ringworm infection, non-androgenic cause alopecia , psoriatic dermatitis or other psoriatic lesions, or uncontrolled seborrheic dermatitis).
- •History of hair transplantation at any time to correct AGA or the use of hair extensions in the 6 months prior to selection.
- •Background or evidence of hair loss other than AGA (for example, due to an autoimmune, endocrine, mechanical or infectious process, or secondary to a dermatological scalp disorder).
- •Use of cosmetic products intended to improve or correct the signs of hair loss (for example, preparations for the scalp that claim to improve hair growth) in the 2 weeks prior to selection.
- •Use of treatments with light or laser beam on the scalp (for example, light emitting diode lamps [LED]) in the previous 3 months.
- •Hypersensitivity to a 5AR inhibitor or to chemically related medications with the treatment being studied.
- •Use of dutasteride within 18 months prior to selection, or the use of finasteride within 12 months prior to selection.
- •Previous use of systemic cytotoxic agents.
- •Use of glucocorticoids (inhaled glucpcorticoids are allowed; topical corticosteroids are allowed as long as they are not applied to the scalp) within 3 months prior to selection.
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