CTRI/2019/11/022122招募中4 期
A Prospective, Open label, single-center, single arm, post marketing study to evaluate the efficacy and safety of D-chiro inositol and myoinositol combination on ovarian function and metabolic factors in women with Polycystic ovarian syndrome (PCOS)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Female subjects oligo menorrhea, amenorrhea with Polycystic ovarian syndrome (PCOS), aged 18 years to 40 years old and meet the following criteria:
- •2.Female subjects 18 years to 40 years (both inclusive) oligo menorrhea, amenorrhea with Polycystic ovarian syndrome (PCOS).
- •3.Subjects who are known cases of PCOS as per the Rotterdam Criteria, which requires presence of 2 of the following 3 conditions:
- •-oligo/anovulation
- •-hyperandrogenism- clinical (hirsutism or less commonly male pattern alopecia) or biochemical (raised free androgen index or free testosterone)
- •-Polycystic ovaries on ultrasound (>=10 small antral follicles seen in each ovary)
- •4.Subjects with primary or secondary infertility (with PCOS as the apparent cause), and attempting to conceive at the time of signing ICF.
- •5.Patients with BMI between 18-29 kg/m2 (both inclusive) at the time of screening.
排除标准
- •1.Systemic diseases- Renal, hepatic cardiac, RS , frank DM, hypertension ,
- •congenital adrenal hyperplasia, ,hyperprolactinemia, acromegaly,
- •functional hypothalamic amenorrhea.
- •2.Past H/O lactic acidosis.
- •3.Patients undergoing IV contrast media study or surgical procedures.
- •4.BMI ( >29 mg/) kg.
- •5.Any ovarian and/or abdominal abnormality interfering with ultrasound examination.
- •6.History / presence of undiagnosed vaginal bleeding.
- •7.History of clinically significant endocrine related abnormality.
- •8.Subject with history of abnormal thyroid function, congenital adrenal hyperplasia, or any other adrenal, pituitary, or ovarian condition that may be the cause of hyperandrogenism and/or anovulation. hyperprolactinemia, Addison and Cushing.
- •9.Subject in whom infertility is related to male factors, or female factors including uterine, tubal or cervical abnormality, primary/premature ovarian failure, pelvic infections, or adhesions etc.
- •10.Subject has received hormonal preparations, including oral/injectable contraceptive preparation in the past 6 months.
- •11.Subject is receiving drugs that can potentially influence ovulation, insulin resistance, and body weight (e.g. anti-epileptics, anti-psychotics, sulfonylureas, insulin sensitizers, corticosteroids, etc) within 5-half-lives prior to screening. Intermittent oral corticosteroids (<=10 mg/day of prednisolone equivalent for <=7 days at a time, or chronic inhaled corticosteroids will be permitted).
- •12.Subject with history of or who test positive for Human Immunodeficiency Virus, Hepatitis B or Hepatitis C infection at screening.
- •13.Subject known to be allergic, hypersensitive, or intolerant to any of the contents of Normoz.
- •14.Subject who smokes or has stopped smoking within the last 3 months prior to screening.
- •15.Subject with history of alcohol or drug abuse within 6 months prior to screening.
- •16.Subject with history of epilepsy, thrombophilia, cardiovascular, gastrointestinal, hepatic, renal, pulmonary, auto-immune disease or any active infection, requiring treatment which at the investigatorâ??s discretion might interfere with the study.
- •17.Subject with history of malignancy.
- •18.Subject who has received an investigational product or has used an invasive investigational medical device within 30 days before the planned first dose of the study drug; or is currently enrolled in an investigational study.
研究者
相似试验
尚未招募
Unknown
A clinical endpoint study to assess the effect of dental cream, strontium chloride 10% w/w medicated dental cream on blood glucose levels in healthy male subjects.CTRI/2024/05/068009Indoco Remedies Limited
尚未招募
不适用
A study to find out the effect and safety of Amlapitta Mishran Suspension in patients with gastritis (stomach inflammation).CTRI/2020/02/023224Shree Dhootapapeshwar Limited
已完成
不适用
A Clinical study to determine whether RESOLV® Endoscopic Hemostat System is safe and effective at achieving hemostasis (stopping bleeding) in adult subjects diagnosed with non-variceal gastrointestinal bleeding (bleeding from just past your throat to just past your stomach).CTRI/2021/12/038478Hemostasis LLC61
尚未招募
不适用
The accuracy of 99mTc-PSMA imaging in the re-staging and response monitoring in patients with metastatic prostate cancerCancer - ProstateMetastatic prostate cancerACTRN12622001030763Fiona Stanley Hospital20
已完成
4 期
A Study To Evaluate Effectiveness and Safety of Dosulepin hydrochloride in Patients with Major Depressive DisorderCTRI/2018/10/016217Dr M Suresh Kumar