EUCTR2023-000224-10-PL进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, multicentre study to evaluate the effect of a 12-week dose of 35 mg DHEA on quality of life in menopausal women. - DHEA/EPH/02/2022
The Pharmaceutical Company LEK-AM Sp. Zo.o.0 个研究点目标入组 100 人开始时间: 2023年4月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- Female
入选标准
- •-BMI 20.0-29.9 kg / m2,
- •- time from the last menstruation at least 12 months,
- •-stable body weight during the last 6 months,
- •- FSH concentration 35-135 mIU / ml and estradiol 5-55 pg / ml,
- •- concentration of total testosterone 0.084 - 0.481 ng / ml,
- •- Beck Depression Score 11–27 points,
- •- result in the Kupperman Scale 17-30 points,
- •- declared sexual activity,
- •- FSFI scale
- •- not using menopausal replacement therapy for at least 6 months,
- •- The ability to understand audit procedures and provide written 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 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Current use of menopausal replacement therapy,
- •- The use of phytoestrogens,
- •- The use of psychotropic drugs,
- •- Use of oral or intravenous glucocorticosteroids,
- •- Vaginal application of DHEA (Prasteron),
- •- Current or history of oncological disease,
- •- Decompensated thyroid disease or other endocrine disease such as Cushing's syndrome
- •- Uncontrolled cardiovascular diseases (hypertension, coronary artery disease, heart failure),
- •- Osteoarthritis with significant pain ailments with the use of steroid therapy,
- •- Rheumatoid arthritis and other rheumatological diseases with the use of steroids,
- •- A disease of the nervous system that may affect the quality of life,
- •- History of mental illness (except postmenopausal depression),
- •- The patient's lack of cooperation
研究者
相似试验
进行中（未招募）
1 期
Study on the safety of the drug runcaciguat and how well it works when given at the highest dose as tolerated by the individual patient whose kidneys are not working properly and suffering at the same time from a disease of the heart and the blood vessels and high blood sugarTreatment of cardiovascular and renal disease in patients with chronic kidney diseaseMedDRA version: 21.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 20.0Level: PTClassification code 10001580Term: AlbuminuriaSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2019-003297-53-ESBayer AG432
进行中（未招募）
不适用
A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety and tolerability of licarbazepine 750-2500 mg/d combined with risperidone in the treatment of manic episodes of bipolar I disorder over 6 weeksBipolar I disorder, manic and mixed episodesEUCTR2004-000113-18-HUovartis Hungaria Kft.430
进行中（未招募）
1 期
Phase 2b dose-ranging study of ALX-0171 in infants and young children hospitalized for RSV lower respiratory tract infectioRSV lower respiratory tract infectionMedDRA version: 20.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2016-001651-49-SKAblynx NV180
进行中（未招募）
1 期
A randomized, double-blind, placebo-controlled, multicenter phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients have achieved complete response with first-line rituximab-chemotherapyDiffuse Large B-Cell LymphomaMedDRA version: 19.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-000498-40-HUovartis Pharma Services AG487
进行中（未招募）
1 期
Safety and efficacy study in patients with moderate to severe nail psoriasisModerate to severe nail psoriasisMedDRA version: 18.0Level: PTClassification code 10028703Term: Nail psoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2012-005413-40-BEovartis Pharma Services AG195