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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Synokem Pharmaceuticals Ltd
- Enrollment
- 162
- Locations
- 11
- Primary Endpoint
- Mean reduction in blood loss during menstruation will be assessed using Pictorial Blood Loss Assessment Chart (PBAC) Score
Study Overview
Brief Summary
This is a Phase III, Multi-center, Prospective, Randomized,Double Blind, Single Dummy, Active Controlled, Comparative Clinical Study.Study will enroll 162 patients with HeavyMenstrual Bleeding (HMB) / Abnormal Uterine bleeding (AUB) due to HormonalImbalance from the different centers in India.
Patients will berecruited after providing written informed consent. After screening, patientswill be randomized (meeting all inclusion & none of the exclusion criteria)in 1:1 ratio to receive either Norethisterone CR Tablets 15 mg once daily alongwith Placebo Tablets (similar to Norethisterone CR Tablets 15 mg) twice daily orNorethisterone Tablets 5 mg three times daily for 84 days. The primary efficacyendpoint of the study is mean reduction in blood loss during menstruation willbe assessed using Pictorial Blood Loss Assessment Chart (PBAC) Score. Secondaryefficacy endpoint includes percentage Responder (Subject with score ≤100 willbe considered as responder) and changes in bleeding pattern post treatment ascompared to baseline. During the study, there will be 5 study visits forefficacy, safety and tolerability assessment.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 25.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia (or unstable angina) within the last 6 months.
- •Patients with uncontrolled (blood sugar levels specified above) or complicated diabetics including diabetic retinopathy, diabetic neuropathy or diabetic nephropathy)
- •Patients with bleeding disorders and patients with active peptic ulceration.
- •Patients with any major psychiatric disorders (including Schizophrenia or depression) not well controlled with treatment.
- •History of non- compliance to medical regimens or those patients unwilling to comply with the study protocol.
- •Pregnant or breast-feeding women.
- •Patients taking other medicines, including those available to buy without a prescription, herbal and complementary medicines.
- •Patient with known allergic to study medication.
- •Patients with intra uterine contraceptive devices.
- •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.
Outcomes
Primary Outcomes
Mean reduction in blood loss during menstruation will be assessed using Pictorial Blood Loss Assessment Chart (PBAC) Score
Time Frame: At Day 28, Day 56 and Day 84
Secondary Outcomes
- Percentage Responder (Subject with score ≤100 will be considered as responder)(At Day 28, Day 56 and Day 84)
- Changes in bleeding pattern post treatment as compared to baseline(At Day 28, Day 56 and Day 84)