NCT03578497已完成2 期
Effects of Interleukin-1 Receptor Antagonism on Hyperandrogenemia in Women With Polycystic Ovary Syndrome - a Prospective, Interventional, Single-arm, Open-label, Proof-of-concept Study
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2018年8月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Absolute change in fasting serum androstenedione level (nmol/l) from start (baseline, day 1) to one week after treatment start with Anakinra.
研究概览
简要总结
A prospective, interventional, open-label, single-arm, proof-of-concept study: 18 women with Polycystic Ovary Syndrome (PCOS) will be treated with 100 mg of Anakinra/Kineret® for 4 weeks. 1 week after last injection patients will have a follow-up and a dexamethasone visit after a dexamethasone suppression test. Goal of this study is to investigate the effect of the Interleukin 1( IL-1) receptor antagonist Anakinra/Kineret® on laboratory and clinical features in women with PCOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Premenopausal women aged 18 years or older
- •Onset of menarche ≥5 years ago
- •Diagnosis of PCOS defined by the Rotterdam criteria
- •High sensitivity C-reactive protein level ≥1 mg/l
- •Follicular phase of menstrual cycle as evident by
- •Serum estradiol level <200 pmol/l AND
- •Serum progesterone level <8 ng/ml
- •Willingness to use non-hormonal contraceptive measures adequate to prevent becoming pregnant during the study
排除标准
- •Intake of any testosterone level modifying drugs in the 8 weeks prior to study inclusion,
- •Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to Anakinra/Kineret,
- •Women who are pregnant or breast feeding,
- •Female participants who are ovariectomized or hysterectomised or post-menopausal
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- •Participation in another study with investigational drug within the 30 days preceding and during the present study,
- •Previous enrolment into the current study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons,
- •Clinical signs of infection in the week before inclusion or history of a severe infection during the last 2 months,
- •Potentially severe immunosuppression or intake of other immunosuppressive drugs
- •Severe hematologic disease
- •Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, active carcinoma),
- •History of or suspected tuberculosis and/or hepatitis B/C
研究组 & 干预措施
IL-1 receptor antagonist Anakinra 100 mg
Experimental
Anakinra (Kineret®; r-metHuIL-1ra, Swedish Orphan Biovitrum AB) is a recombinant, non-glycosylated form of the human IL-1Ra in a 100 mg/ 0.67 ml solution for subcutaneous injection. Anakinra/Kineret® is supplied in single use prefilled glass syringes with 27 gauge needles as a sterile, clear, colorless-to-white, preservative free solution for daily s.c. administration over a time period of 28 days.
干预措施: IL-1 receptor antagonist Anakinra (Drug)
结局指标
主要结局
Absolute change in fasting serum androstenedione level (nmol/l) from start (baseline, day 1) to one week after treatment start with Anakinra.
时间窗: 7 days
Absolute change in fasting serum androstenedione level (nmol/l) from start (baseline, day 1) to one week after treatment start with Anakinra.
次要结局
- Pituitary hormones (luteinizing hormone (LH), follicle stimulating hormone (FSH), adrenocorticotropic hormone (ACTH) [IU/L])(Day 1, 7, 14, 21, 28 and 35)
- inflammatory marker C reactive protein (CRP) [mg/l](Day 1, 7, 14, 21, 28 and 35)
- Ferriman-Gallwey-score(Day 1 and 28)
- Sebum production measures(At day 1 and 28)
- inflammatory marker white blood cell count [x109/l],(Day 1, 7, 14, 21, 28 and 35)
- Change in androstenedione level (nmol/l) from start (baseline, day 1) to days 14, 21, 28, and 35 after treatment start with Anakinra.(Days 14, 21, 28, and 35 after treatment start with Anakinra)
- Self-reported frequency of hair removal (times/week)(At day 1 and 28)
- Plewig-Kligman-score(At day 1 and 28)
- Estradiol (pmol/l), free testosterone (nmol/l), total testosterone (nmol/l), sex hormone-binding globulin (SHBG) [nmol/l], Anti-Muellerian Hormone [pmol/l], dehydroepiandrosterone (DHEA) [nmol/l]), basal cortisol (nmol/l)(Day 1, 7, 14, 21, 28 and 35)
- Fasting glucose (mmol/l), homeostatic model of assessment of insulin resistance (HOMA-IR)(At day 1, 7, 14, 21, 28 and 35)
- Treatment response according to a Dexamethasone suppression test(At days 35 and 36)
- inflammatory marker IL-6 [pg/ml](Day 1 and 28)
- Ovulation and menstruation rates [%](Between day 1 and day 35)
- inflammatory marker IL-1Ra [pg/ml](Day 1, 7, 14, 21, 28 and 35)
- Change in 11-oxygenated androgens (e.g. 11-ketotestosterone, 11-ketoandrostenedione, 11β-hydroxytestosterone, 11β-hydroxyandrostenedione [nmol/l]) on days 7, 14, 28, and 35 after treatment start with Anakinra(Days 7, 14, 28, and 35 after treatment start with Anakinra)
研究者
研究点 (1)
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