2023-509259-15-01招募中4 期
Optimizing metformin use in polycystic ovary syndrome - A randomized controlled trial
HUS-yhtymae1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2025年2月6日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Anthropometrics (weight)
研究概览
简要总结
To find out if a metformin dose of 1500mg is inferior to 2250 mg per day regarding biochemical and clinical outcomes in overweight individuals 18-37 years of age with PCOS.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-37 years of age
- •A diagnosis of PCOS according to the updated 2023 International PCOS guideline
- •BMI ≥ 25 kg/m2 and <40 kg/m2
- •Signed informed consent and willingness to comply with the trial procedures
排除标准
- •Females not meeting the 2003 Rotterdam criteria for PCOS
- •Investigator site staff directly involved in the conduct of the study and their family members
- •Females with hormonal contraceptive during the last 3 months
- •Women that are pregnant or breastfeeding
- •Females with an untreated diabetes, hypothyroidism or hyperprolactinemia
- •Use of medications for diabetes, high cholesterol, obesity and cortisone (per oral)
- •Serious mental illness
- •Females with contraindication for use of metformin (hypersensitivity to metformin, acute metabolic acidosis, severe renal failure, hepatic insufficiency, heart- or respiratory failure)
- •A planned surgical intervention during the next 26 weeks
结局指标
主要结局
Anthropometrics (weight)
Anthropometrics (weight)
Androgenicity (hirsutism and testosterone)
Androgenicity (hirsutism and testosterone)
Metabolic (HOMA-IR)
Metabolic (HOMA-IR)
Gastrointestinal side-effects (nausea, vomiting, abdominal pain)
Gastrointestinal side-effects (nausea, vomiting, abdominal pain)
Polycystic ovary morphology: AMH
Polycystic ovary morphology: AMH
次要结局
- Androgenicity: FAI, SHBG, DHEAS, androstenedione, free testosterone, acne and alopecia
- Menstrual cyclicity (questionnaire where asking how long the two previous cycles were (days)
- Quality of life and weight stigma: anxiety, weight stigma
- Metabolic: fasting glucose, fasting insulin, HbA1C, lipids, CRP, ALAT, GGT, OGTT, FLI, Matsuda Index, TyG index
- Polycystic ovary morphology: ultrasound (follicle number per ovary, ovarian volume)
- Anthropometric (BMI, waist-hip-ratio, WC, BAI, body composition, bloodpressure, pulse)
研究者
Johanna Melin
Scientific
HUS-yhtymae
研究点 (1)
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