Health Condition 1: Z30- Encounter for contraceptive management
Conditions
Interventions
Intervention1: Estetrol (14.2 mg) and Drospirenone (3 mg) Tablets: One tablet is to be taken daily for 28 consecutive days. The tablets must be taken every day at about the same time, if necessary, wi
Sponsors
Sun Pharma Laboratories Limited (SPLL)
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women of child bearing potential of age between 18 to 50 years (both inclusive) at the time of screening and willing to provide written informed consent 2. Females with a body mass index (BMI) of 18.5 to 40 (both inclusive) 3. Heterosexually active females at risk of pregnancy and requesting contraception 4. Females with at least 3 regular menstrual cycles 5. Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Enrolment 6. Willing to use the Investigational product as the primary method of contraception for the duration of the study [Note: Women of childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Post-menopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age]
Exclusion criteria
Exclusion criteria: 1. Participants with known hypersensitivity or any other contraindication to the Investigational product or any of its components 2. Currently pregnant or with the intention to become pregnant during the course of the study 3. Currently breastfeeding or before two spontaneous menstruations have occurred after cessation of breastfeeding prior to Screening 4. Less than 6 weeks since last delivery/2nd trimester abortion and before spontaneous menstruation has occurred following a delivery or 2nd trimester abortion 5. Participants with history or current or suspected carcinoma breast or any other estrogen-dependent neoplasia or any undiagnosed breast mass (to be ruled out via breast examination at Screening) 6. Participants with history of pelvic malignancy or abnormal PAP smear reports at Screening 7. Participants with history of deep vein thrombosis or pulmonary embolism or prolonged immobilization or major surgery planned during the conduct of the study 8. Participants with history of or current pancreatitis OR gall bladder disease OR COC related cholestasis 9. Participants with history of use of medications that may increase serum potassium concentration (like but not limited to: ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonist and non-steroidal anti-inflammatory drugs) 10. Participants using any of the following medications within 30 days prior to Enrolment: a) Cytochrome P450 3A4 (CYP3A4) inducers: barbiturates, primidone, bosentan, felbamate, griseofulvin, oxcarbazepine, topiramate, carbamazepine, phenytoin, rifampicin, St Johnâ??s wort b) CYP3A4 inhibitors: azole antifungals, phenylbutazone, modafinil, cimetidine, verapamil, macrolides, diltiazem and grapefruit juice c) Human immunodeficiency virus (HIV)/Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors [Note: Maximum washout period allowed within the study is for 4 weeks (28 days). If the participant requires washout more than 4 weeks after screening, then such participants will be excluded from the study] 11. Participants with history of any clinically significant medical and/or psychological condition that, in the opinion of the Investigator would jeopardize the safety of the Participant or affect the validity of the study results [for example but not limited to: renal impairment, cardiovascular disorders (like: ischemic heart disease, cardiomyopathy, valvular heart disease, New York Heart Association (NYHA) Class III/IV left ventricular failure, arrhythmia, atrial fibrillation, myocardial infarction, angina, congestive heart failure, etc.), cerebrovascular disease, ophthalmologic disease, psychiatric disorder, neurodegenerative disease, epilepsy or seizure disorder or any neurological disorder, any autoimmune disorders, uncontrolled thyroid disorder, hyperkalemia, hepatic impairment ] 12. Participants with Type I diabetes mellitus or uncontrolled Type II diabetes mellitus OR controlled diabetes with vascular involvement 13. Participants with arterial hypertension (both controlled and uncontrolled) with a systolic blood pressure (SBP) of greater then and equal to 140 mm Hg and diastolic blood pressure (DBP) greater than and equal to 90 mmHg 14. Participants who tested positive for human immunodeficiency virus (HIV) and/or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of on-treatment pregnancies as assessed by the Pearl Index in participants aged 18 to 35 yearsTimepoint: Number of on-treatment pregnancies as assessed by the Pearl Index in participants aged 18 to 35 years | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of on-treatment pregnancies as assessed by the method failure Pearl Index in participants aged 18 to 35 yearsTimepoint: [Time frame: Up to Week 24];The cumulative pregnancy rate Index in participants aged 18 to 35 yearsTimepoint: [Time frame: Up to Week 24];The number of on-treatment pregnancies as assessed by Pearl Index in the overall study populationTimepoint: [Time frame: Up to Week 24];The number of on-treatment pregnancies as assessed by the method failure Pearl Index in the overall study populationTimepoint: [Time frame: Up to Week 24];The cumulative pregnancy rate Index in the overall study populationTimepoint: [Time frame: Up to Week 24] ;Proportion of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)Timepoint: [Time frame: Throughout the study period] | — |
Countries
India
Contacts
Public ContactAbhijit Bhuwad
Sun Pharma Laboratories Limited
Outcome results
None listed