A Clinical Trial to study the effect of Norethisterone CR Tablets in Women with Heavy Menstrual Bleeding / Abnormal Uterine bleeding.
- Conditions
- Health Condition 1: N938- Other specified abnormal uterine and vaginal bleeding
- Registration Number
- CTRI/2019/06/019490
- Lead Sponsor
- Synokem Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 172
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean reduction in blood loss during menstruation will be assessed using Pictorial Blood Loss Assessment Chart (PBAC) ScoreTimepoint: At Day 28, Day 56 and Day 84
- Secondary Outcome Measures
Name Time Method Changes in bleeding pattern post treatment as compared to baselineTimepoint: At Day 28, Day 56 and Day 84;Percentage Responder (Subject with score â?¤100 will be considered as responder)Timepoint: At Day 28, Day 56 and Day 84