CTRI/2019/06/019490已完成3 期
A Phase III, Multi-center, Prospective, Randomized, Double Blind, Single Dummy, Active Controlled, Comparative Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Norethisterone CR Tablets 15 mg versus Norethisterone Tablets 5 mg to Arrest Bleeding in Women with Heavy Menstrual Bleeding (HMB) / Abnormal Uterine bleeding (AUB) due to Hormonal Imbalance.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 172
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
- •Female patients of age 25-45 years (both inclusive)
- •Patients having known history and current signs / symptoms of Abnormal Uterine Bleeding / Heavy Menstrual Bleeding
- •Patients willing to give written informed consent and comply with the study procedure
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 any major psychiatric disorders (including Schizophrenia or depression) not well controlled with treatment.
- •5. History of non- compliance to medical regimens or those patients unwilling to comply with the study protocol.
- •6. Pregnant or breast-feeding women.
- •7. Patients taking other medicines, including those available to buy without a prescription, herbal and complementary medicines.
- •8. Patient with known allergic to study medication.
- •9. Patients with intra uterine contraceptive devices.
- •10. Patients with epilepsy, high blood pressure, asthma, pulmonary embolism & deep vein thrombosis, hardness or lumps in the breasts, history of breast cancer, hepatic, renal or any other condition according to the investigator may affect the conduct and result of the study.
研究者
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