Oral hormonal contraceptive for women without uncontrolled current diseases between 18-45 years. MedDRA version: 13.1 Level: PT Classification code 10010808 Term: Contraception System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Drospirenone
Product Code: LF111
Pharmaceutical Form: Tablet
INN or Proposed INN: Drospirenone
CAS Number: 67392-87-4
Current Sponsor code: LF111
Concentration unit: mg milligram(s)
Conc
Sponsors
Laboratorios León Farma S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women without uncontrolled current diseases at risk of pregnancy, at the age of 18-45 years 2. For starters: At least four menstrual cycles during the last six months before Visit 1a were regular (i.e. cycle length between 24 and 35 days) 3. Systolic blood pressure =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant subject 2. Breastfeeding subject 3. Subject is known to or suspected of not being able to comply with the study protocol and the use of the IMP 4. Abnormal finding on pelvic, breast or ultrasound examination that precludes participation in the trial 5. Unexplained amenorrhoea, known polycystic ovary syndrome 6. Subject having ASC-US or more severe finding on Pap smear 7. Known contraindication or hypersensitivity to ingredients (drospirenone) or excipients of IMP (cellulose, lactose, silicon dioxide, magnesium stearate, corn starch, polyethylene glycol, polyvinyl pyrrolidone, polyvinyl alcohol, aquariusBT16035 cottage green, talc, titanium dioxide) 8. Significant cardiovascular, hepatic or renal disease, diabetes with vascular involvement, uncontrolled thyroid disorder or current venous thrombosis or embolism 9. Evidence or history of alcohol, medication or drug abuse (within the last 12 months) 10. Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a 11. Prohibited previous medication / contraceptives ((injectable hormonal methods of contraception within the last 6 months before V1a, progestin-releasing IUD or contraceptive implant within the last 2 months before V1a, anti-retroviral therapy within the last 6 months before V1a) 12. Dependence on prohibited co-medication 13. Planned surgery during the anticipated time of participation in this trial requiring withdrawal of an oral contraceptive 14. Regular concomitant use of barrier contraceptive methods, spermicides, IUDs or other contraceptive measures (excepting occasional use due to risk of infection) 15. Evidence or history of neurotic personality, psychiatric illness or suicide risk 16. Participation in another trial of investigational drugs or devices parallel to, or less than 90 days before trial entry, or previous participation in this trial 17. Employee of the investigator or trial centre, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial centre, or family member of the employees or the investigator 18. Any condition that, in the opinion of the investigator, may jeopardise the trial conduct according to the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the contraceptive efficacy of LF111;Secondary Objective: To demonstrate the safety and tolerability of LF111;Primary end point(s): Primary efficacy endpoint: Overall Pearl index (overall PI) ;Timepoint(s) of evaluation of this end point: After study termination (last patient/last visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: - Pearl Index for method failures (electronic diaries) - Pearl Index after correction for back-up contraception - pregnancy ratio;Timepoint(s) of evaluation of this end point: After study termination (last patient/last visit) | — |
Countries
Czech Republic, Germany, Hungary, Romania
Outcome results
None listed