CTRI/2020/11/029044尚未招募4 期
A clinical study efficacy and safety of Evakind Tablets in women diagnosed with PCOS
IMS BH0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •Rotterdam Criteria
- •Two of the three following criteria are diagnostic of the condition, assuming other causes have been excluded:
- •Polycystic Ovaries
- •Oligo-ovulation or anovulation. Number of menstrual cycles in last 1 year ( <8/year).
- •Clinical and/or biochemical signs of Hyperandrogenism (HA)
- •Signs of clinical HA:
- •Sexual hair growth graded by modified Ferriman-Gallwey3 (mFG) Score >=6-8
- •Global Acne Grading System4
- •Androgenic alopecia
- •Biochemical Signs of HA:
- •Total Testosterone
- •Luteinizing Hormone (LH)
- •Follicle Stimulating Hormone (FSH)
- •Investigational
- •Polycystic ovarian Morphology confirmation by Ultrasonography
- •Presence of at least 12 follicles measuring 2 to 9 mm in the whole ovary.
- •increased ovarian volume (greater than 10 cm3)
排除标准
- •Age >40 years or patients with menopausal levels of FSH ( > 20mIU/mL)
- •Hyperprolactinemia (Serum prolactin >30 ng/mL)
- •Patients with known 21-hydroxyase deficiency5 (Serum 17-hydroxyprogesterone < 2ng/mL)
- •Patients with uncorrected Thyroid disease ( defined as TSH <0.2 mIU/mL or >5.5 mIU/mL)
- •Patients on oral contraceptives, depo progestins, or hormonal implants, GnRH agonists and antagonists, IUCD (intra uterine contraceptive device) or using barrier contraceptives.
- •Organic lesion of the reproductive tract if any:
- •1.Benign growth
- •2.Malignant growth
- •3.Extensive cervical erosion
- •4.Cervical polyps
- •5.Endometriosis
- •History of spontaneous abortion in last 3 months.
- •History of any of the following systemic disorders:
- •1.Diabetes mellitus type 1
- •2.Coronary artery disease
- •3.Hypertension
- •4.Renal disease
- •5.Hepatic disease
研究者
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