跳至主要内容
临床试验/SLCTR/2015/007
SLCTR/2015/007已完成3 期

A Randomized Controlled Trial to compare the effectiveness of cyproterone acetate /ethinyl estradiol, desogestrel / ethinyl estradiol and metformin on improving hirsutism, hormonal and metabolic features of polycystic ovary syndrome.

niversity Grants Commission, Sri Lanka0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
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

入排标准

入选标准

  • 1.Age more than 18 years and less than 40 years
  • 2.Diagnosis of PCOS according to the 2003 Rotterdam Consensus conference criteria
  • 3.One or more of the following dermatological manifestations of hyperandrogenism: hirsutism, androgenetic alopecia, acne

排除标准

  • 1. Smoking, alcoholism, drug addiction
  • 2. Current pregnancy.
  • 3. Current or previous use (up to three months before the study) of oral, vaginal, monthly injectable, or transdermal combined hormonal contraceptives
  • 4. Current or previous use (up to six months before the study) of a long-lasting hormonal contraceptive method (injectable, implant, or intrauterine device)
  • 5. Current use of antiandrogens, hypoglycemic drugs, statins
  • 6. Presence of systemic diseases (diabetes mellitus, cardiovascular disease, autoimmune diseases, liver disease, thyroid disease, or congenital adrenal hyperplasia)
  • 7. Personal history of arterial or venous thrombosis
  • 8. Puerperium of 24 weeks or less
  • 9. Psychiatric illness or on anti-psychotic drugs
  • 10. Renal disease
  • 11. Migraine
  • 12. Other causes of hyperandrogenism
  • 13. Women wishing to conceive during the next 12 months
  • 14. Personal or family history of breast carcinoma
  • 15. Women with contraindications to use oral contraceptives (WHO criteria) and metformin
  • 16. Inability to give the informed consent
  • 17. History of metformin use within the previous 8 weeks

研究者

发起方
niversity Grants Commission, Sri Lanka

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