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.

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 Dysfunctional Uterine Bleeding due to Hormonal Imbalance.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/02/007931

Enrollment

188

Registered

2017-02-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Women who Diagnosed with Dysfunctional uterine bleeding due to hormonal imbalance

Interventions

Intervention1: Norethisterone (10mg CR Tablets): Norethisterone 10 mg CR to be taken once daily from 5th to 25th day of menstruation, with or without regards to food Control Intervention1: Medroxyprog

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of Norethisterone versusMedroxyprogesterone 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	—

Secondary

Measure	Time frame
To compare the safety and tolerability of Norethisterone versusMedroxyprogesterone 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	—

Countries

India

Contacts

Public ContactMr Sanjib Kumar Panda

Ocius Life Sciences Private Limited

sanjib@ociuslife.com9003580729

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026