ACTRN12623000166673尚未招募4 期
Evaluating prevention of Muscle Loss After Menopause Using Testosterone: The PAMELA study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 55 Years 至 70 Years（—）
- 性别
- Female
入选标准
- •Naturally postmenopausal women, aged 55-70 years, who are not taking medications that might influence hormone levels or muscle/bone health. Participants must be agreeable to taking vitamin D3 1000 IU/day and making no meaningful change in their exercise regime or diet over the course of the study. Participants will be required to have a body mass index between 18 and 35 kg/m2, a clinically acceptable mammogram in the preceding 2 years and clinically acceptable cervical screening test results within the preceding 5 years.
排除标准
- •1.Body mass index <18 or >35 kg/m2
- •2.Current or recent (in the past 12 months) use of systemic estrogen replacement therapy or tibolone (vaginal estrogen permitted)
- •3.Current or recent (in the past 12 months) use of antiandrogens
- •4.Use of any drugs affecting bone metabolism such as bisphosphonates, denosumab, systemic corticosteroids, antineoplastic drugs, thiazide diuretics, anti-epileptic drugs, and heparin in the last 5 years
- •5.History of testosterone or dehydroepiandrosterone treatment in the last 5 years
- •6.Plans to commence a weight reduction diet for the duration of the study
- •7.Known allergy to almonds (a constituent of the cream)
- •8.Severe chronic skin disease (such as eczema or psoriasis) that is likely to interfere with transdermal drug absorption
- •9.Intolerance to transdermal testosterone
- •10.Clinically significant infection requiring systemic antibiotics
- •11.Undiagnosed vaginal bleeding
- •12.Evidence of clinical hyperandrogenism (hirsutism, androgenic alopecia, or acne) as assessed by the recruiting clinician
- •13.Taking herbal remedies, grapefruit juice, or medications known to be strong inducers or inhibitors of cytochrome P450 3A4 or known to interact with testosterone metabolism or reproductive hormone levels.
- •14.Use of protein supplementation is permitted but participants will be restricted from commencing new any new protein supplement or increasing their consumption.
- •15.History of smoking within the past year, active substance abuse, or alcohol consumption of more than two standard drinks per day
- •16.Severe musculoskeletal, neurological, or metabolic disease which might influence the results of the study
- •17.Present or previous systemic cancer diagnosis in the last 5 years
- •18.Donation of blood within the last 6 weeks or plasma within 7 days of the first dosing in this study
- •19.Abnormal thyroid function (abnormal thyroid stimulating hormone (TSH) value confirmed by a free T4 outside laboratory range)
- •20.Being considered by a chief investigator to be unsuitable for participation in the study
研究者
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