CTRI/2017/02/007931招募中3 期
An Open Label, Randomized, Multicentric, Parallel Group, Comparative, Phase III Study to Evaluate Efficacy and Safety of Norethisterone CR Tablet Versus Medroxyprogesterone Acetate Tablet to Arrest Bleeding in Women with DysfunctionalUterine Bleeding due to Hormonal Imbalance.
Synokem Pharmaceuticals Limited0 个研究点目标入组 188 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 188
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 â?? Women between 25 - 45 years.
- •2. Actively bleeding female patients withDysfunctional Uterine Bleeding
- •due to hormonal imbalance in the reproductive age group.
- •3. Patients willing to give written informed consent.
排除标准
- •1. Patients who have suffered a myocardial infarction, stroke, or life
- •threatening arrhythmia (or unstable angina) within the last 6 months.
- •2. Patients with uncontrolled (blood sugar levels specified above) or
- •complicated diabetics including diabetic retinopathy, diabetic neuropathy
- •or diabetic nephropathy)
- •3. Patients with bleeding disorders and patients with active peptic ulceration.
- •4. Patients with multiple myeloma, leukemia, lymphoma, agammaglobinaemia.
- •5. Patients with spinal cord injury.
- •6. Patients with any major psychiatric disorders (including Schizophrenia or
- •depression) not well controlled with treatment.
- •7. Significant history of presence of hematological, gastrointestinal, hepatic
- •or renal disease.
- •8. Patients with clinically significant abnormal LFT & RFT Values.
- •9. History of non- compliance to medical regimens or those patients
- •unwilling to comply with the study protocol.
- •10. Pregnant or breast-feeding women.
- •11. Patients with epilepsy, high blood pressure, or asthma.
- •12. Patients with liver or kidney problems.
- •13. Patients with pulmonary embolism & deep vein thrombosis.
- •14. Patients diagnosed with jaundice, severe itching, or a skin condition
- •called pemphigoid gestationis during a pregnancy.
- •15. Patients taking other medicines, including those available to buy without
- •a prescription, herbal and complementary medicines.
- •16. Patient allergic to any medicine.
- •17. Patients with hardness or lumps in the breasts.
- •18. Patients with family history of breast cancer.
- •19. Patients with intra uterine contraceptive devices.
研究者
相似试验
已完成
3 期
To study efficacy and safety of Progesterone SR tablets in patient with secondary amenorrheaCTRI/2016/11/007433Synokem Pharmaceuticals Ltd388
已完成
3 期
se of Releeva 5 in menstrual irregularityCTRI/2020/06/026204Tirupati Life Sciences90
进行中（未招募）
不适用
An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAJECT™ and Regular Human Insulin in Patients with Type 2 Diabetes MellitusEUCTR2006-006600-11-DEBIODEL Inc.400
进行中（未招募）
不适用
An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAJECT™ and Regular Human Insulin in Patients with Type 1 Diabetes MellitusDiabetes Mellitus Type 1MedDRA version: 8.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusEUCTR2006-006599-39-DEBIODEL Inc.400
已完成
2 期
Open label study comparing Insulin Tregopil (IN-105) with Insulin Aspart in Type 2 Diabetes Mellitus PatientsCTRI/2017/11/010560Biocon Limited91