"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
- Unknown
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.To evaluate the regularization of Menses
研究概览
简要总结
This is A prospective, open-label, Single-center,single arm post-marketing study to evaluate the efficacy and safety of Normozon ovarian function and metabolic factors in women with Polycystic ovariansyndrome (PCOS). The study intends to recruit 100patients from 1 site in India who fit the eligibilitycriteria and provide informed consent to participate in the study. Normoz is one of thestandard treatments for this condition. Being an open label study there will beno blinding procedures.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
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 investigator’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.
结局指标
主要结局
1.To evaluate the regularization of Menses
时间窗: 1.Regularization of Menses measured by change from baseline to Month 6(3rd Month Interim). | 2.Improvement in Ovulatory function measured by change from baseline to Month 6(3rd Month Interim). | 3.Normalization of Thyroid Profile measured by change from baseline to Month 6(3rd Month Interim). | 4.Proportion of subjects achieving spontaneous ovulation at the end of 3 months of treatment with Normoz. (0,3 months)
2.To assess the Improvement in Ovulatory function
时间窗: 1.Regularization of Menses measured by change from baseline to Month 6(3rd Month Interim). | 2.Improvement in Ovulatory function measured by change from baseline to Month 6(3rd Month Interim). | 3.Normalization of Thyroid Profile measured by change from baseline to Month 6(3rd Month Interim). | 4.Proportion of subjects achieving spontaneous ovulation at the end of 3 months of treatment with Normoz. (0,3 months)
3.To assess the proportion of subjects achieving spontaneous ovulation at the end of 3 months.
时间窗: 1.Regularization of Menses measured by change from baseline to Month 6(3rd Month Interim). | 2.Improvement in Ovulatory function measured by change from baseline to Month 6(3rd Month Interim). | 3.Normalization of Thyroid Profile measured by change from baseline to Month 6(3rd Month Interim). | 4.Proportion of subjects achieving spontaneous ovulation at the end of 3 months of treatment with Normoz. (0,3 months)
4.To evaluate the normalization of Thyroid Profile
时间窗: 1.Regularization of Menses measured by change from baseline to Month 6(3rd Month Interim). | 2.Improvement in Ovulatory function measured by change from baseline to Month 6(3rd Month Interim). | 3.Normalization of Thyroid Profile measured by change from baseline to Month 6(3rd Month Interim). | 4.Proportion of subjects achieving spontaneous ovulation at the end of 3 months of treatment with Normoz. (0,3 months)
5.To evaluate the regularization of Menses
时间窗: 1.Regularization of Menses measured by change from baseline to Month 6(3rd Month Interim). | 2.Improvement in Ovulatory function measured by change from baseline to Month 6(3rd Month Interim). | 3.Normalization of Thyroid Profile measured by change from baseline to Month 6(3rd Month Interim). | 4.Proportion of subjects achieving spontaneous ovulation at the end of 3 months of treatment with Normoz. (0,3 months)
6.To assess the Improvement in Ovulatory function
时间窗: 1.Regularization of Menses measured by change from baseline to Month 6(3rd Month Interim). | 2.Improvement in Ovulatory function measured by change from baseline to Month 6(3rd Month Interim). | 3.Normalization of Thyroid Profile measured by change from baseline to Month 6(3rd Month Interim). | 4.Proportion of subjects achieving spontaneous ovulation at the end of 3 months of treatment with Normoz. (0,3 months)
7.To assess the proportion of subjects achieving spontaneous ovulation at the end of 3 months.
时间窗: 1.Regularization of Menses measured by change from baseline to Month 6(3rd Month Interim). | 2.Improvement in Ovulatory function measured by change from baseline to Month 6(3rd Month Interim). | 3.Normalization of Thyroid Profile measured by change from baseline to Month 6(3rd Month Interim). | 4.Proportion of subjects achieving spontaneous ovulation at the end of 3 months of treatment with Normoz. (0,3 months)
8.To evaluate the normalization of Thyroid Profile
时间窗: 1.Regularization of Menses measured by change from baseline to Month 6(3rd Month Interim). | 2.Improvement in Ovulatory function measured by change from baseline to Month 6(3rd Month Interim). | 3.Normalization of Thyroid Profile measured by change from baseline to Month 6(3rd Month Interim). | 4.Proportion of subjects achieving spontaneous ovulation at the end of 3 months of treatment with Normoz. (0,3 months)
次要结局
- 1.Improvement in clinical features of PCOS(2.change in oral glucose tolerance test)