A Clinical Trial to study the effect of Norethisterone CR Tablets in Women with Heavy Menstrual Bleeding / Abnormal Uterine bleeding.

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/06/019490

Enrollment

162

Registered

2019-06-03

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: N938- Other specified abnormal uterine and vaginal bleeding

Interventions

Intervention1: Norethisterone CR Tablets 15 mg: Norethisterone CR Tablets 15 mg once daily along with placebo (similar to Norethisterone CR Tablets 15 mg) twice daily orally for 84 days Control Interv

Eligibility

Inclusion criteria

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

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 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactAbhinav Arora

Synokem Pharmaceuticals Ltd.

abhinavarora@synokempharma.com9811882440

Outcome results

None listed

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