Oral hormonal contraceptive for women without uncontrolled current diseases between 18-45 years. MedDRA version: 15.1 Level: PT Classification code 10030970 Term: Oral contraception System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Drospirenone
Product Code: LF111
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Drospirenone
CAS Number: 67392-87-4
Current Sponsor code: LF111
Concentration unit: mg milli
Sponsors
Laboratorios León Farma S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Woman 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 IMPs 4. Abnormal finding on pelvic, breast or intravaginal 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, desogestrel) or excipients of IMPs 8. Significant cardiovascular, hepatic or renal disease, diabetes mellitus, uncontrolled thyroid disorder, history or presence of arterial / venous thrombosis or embolism 9. Undiagnosed vaginal bleeding 10. Known or suspected sex-steroid sensitive malignancies 11. Presence or history of severe hepatic disease as long as liver function values have not returned to normal 12. Evidence or history of alcohol, medication or drug abuse (within the last 12 months) 13. Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a 14. 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, microsomal enzyme-inducing drugs within the last 28 days before the start of IMP intake) 15. Dependence on prohibited co-medication 16. Planned surgery during the anticipated time of participation in this trial requiring withdrawal of an oral contraceptive 17. Regular concomitant use of barrier contraceptive methods, spermicides, IUDs or other contraceptive measures (excepting occasional use due to risk of infection) 18. Evidence or history of neurotic personality, psychiatric illness or suicide risk 19. 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 20. Employee of the investigator or trial centre or family member of the employees or the investigator 21. Any condition that, in the opinion of the investigator, may jeopardise the trial conduct according to the protocol 22. Subject concerned has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities 23. Adrenal insufficiency, history or presence of cerebral-vascular disease, headaches with focal neurological symptoms, major surgery with prolonged immobilisation, cholestatic jaundice of pregnancy or jaundice with prior pill use
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 in comparison to desogestrel 0.075 mg, especially regarding bleeding pattern.;Primary end point(s): 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): - Pearl Index for method failures - Pearl Index after correction for back-up contraception - Pregnancy ratio - safety and tolerbility endpoints;Timepoint(s) of evaluation of this end point: After study termination (last patient/last visit) | — |
Countries
Austria, Czech Republic, Germany, Hungary, Poland, Romania, Slovakia, Spain
Contacts
Public ContactHead of Clinical Development – Gyna
CHEMO France S.A.
Outcome results
None listed