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: 2021年11月24日

试验速览

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•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)

•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

发起方

IMS BH