To Evaluate Efficacy and Safety of Norethisterone CR Tablet Versus Medroxyprogesterone Acetate Tablet for the treatment of Women with Dysfunctional Uterine Bleeding due to Hormonal Imbalance.
- Conditions
- Health Condition 1: null- Women who Diagnosed with Dysfunctional uterine bleeding due to hormonal imbalance
- Registration Number
- CTRI/2017/02/007931
- Lead Sponsor
- Synokem Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 188
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of Norethisterone versusMedroxyprogesterone AcetateTablets in <br/ ><br>women with Dysfunctional Uterine Bleeding due to hormonal imbalance.Timepoint: Day 1, On 28th day of 1st menstruation from screening,On 28th day of 2nd menstruation from screening, On 28th day of 3rd menstruation from screening
- Secondary Outcome Measures
Name Time Method To compare the safety and tolerability of Norethisterone versusMedroxyprogesterone <br/ ><br>AcetateTablets in women with Dysfunctional Uterine Bleeding due to hormonal imbalance.Timepoint: Day 1, On 28th day of 1st menstruation from screening,On 28th day of 2nd menstruation from screening, On 28th day of 3rd menstruation from screening