A Case-Cohort, Observational Study to Understand Clinical Safety and Effectiveness of Dydrogesterone In High Risk Pregnancy

Name of Sponsor:

Torrent Pharmaceuticals Ltd, India

|Name of the study Drug

Dydrogesterone Tablets

|Title of Study

A Case-Cohort, Observational Study to Understand Clinical Safety and Effectiveness of Dydrogesterone In  High Risk Pregnancy (D-ONE Study)

|Objectives:

To evaluate and understand the clinical utility oral Dydrogesteone in women having high risk pregnancy in real world clinical settings

|Study Population

Adult females identified as having high risk cases requiring progesterone supplementation

|Settings

Hospitals/Nursing homes or Outpatient settings having access to laboratory facilities for diagnostic and biochemical safety tests

|Study design:

Case-Cohort Observational Study

|Study endpoints

Primary Endpoint:

§  Ongoing pregnancy rate at 24th weeks (fetal viability confirmed with ultrasound)

Secondary Endpoints:

§  Patient’s acceptability to treatment

§  Safety assessment for Common Adverse events (>1%)

|Number of patients (planned):

2500 patients will be enrolled in the study from 250 different sites across India.

|Inclusion            and

exclusion criteria

Main criteria for inclusion:

ü  Pregnant women up to 12 weeks of gestation

ü  Women with a history of miscarriage with suspect luteal phase insufficiency

Main criteria for exclusion:

 

ü    Known hypersensitivity to individual ingredients ü Heavy vaginal bleeding requiring surgical intervention.

ü    Any uterine anomalies.

ü    Any associated medical and surgical illness.

|**Duration of study:**10 months(Observation period)

|Duration of observation Till 24 weeks of pregnancy

|Study drug, dosage and mode of administration:

Oral Dydrogesterone tablet 10mg

10 mg once or several times a day for atleast 20 weeks or beyond as directed by physician |Criteria for evaluation:

•      Clinical response: Number of patients on oral dydrogesterone and having successful continuation of pregnancy > 24th weeks of gestation ((fetal viability confirmed with ultrasound) will be considered

•      Safety: Adverse events: as per WHO classification, incidence of ‘Common’ Treatment emergent adverse events of  ≥ 1%.

|Statistical

Consideration

Data will be presented using descriptive statistics in the form of frequencies and percentages for qualitative variables, means, medians, standard deviations, minimal and maximal values and 95% confidence interval for quantitative variables.

The continuous and categorical variables will be assessed for significance using the Student’s T and Fischer’s Exact Test with p <0.05 considered to be clinically significant using the two-tailed test

A total sample size of 2500 cases had been planned for enrollment at 250 centers across India.

In case of SAE, the clinical investigator or the sponsor (representative) needs to report the Event information on pv@torrentpharma.com AND CDSCO Suspect ADR Report Form once aware of the event as Date of Reporting (DOR) in addition to Date of Event (DOE).