Oral contraception for females aged 18-35 MedDRA version: 20.0 Level: SOC Classification code 10042613 Term: Surgical and medical procedures System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10030970 Term: Oral contraception System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Code: LPRI-421
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: DIENOGEST
CAS Number: 65928-58-7
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration n
Sponsors
Exeltis France S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female subjects aged 18-35 years. 2. Regular cycles during the last three months before consent, when not using hormonal contraception. 3. At least three complete menstrual cycles after delivery/abortion/miscarriage (only applicable for women who were pregnant within the last six months). 4. Body Mass Index (BMI): 18 kg/m2 = BMI =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 Pregnancy, wish for pregnancy or breastfeeding 2 Subject with self-reported heavy vaginal bleeding 3 Subject with relevant uncontrolled concomitant disease 4 Subject is known to or suspected of not being able to comply with the trial protocol, the use of the IMP or the use of the diary 5 Abnormal finding on pelvic, breast or ultrasound examination that in the investigator’s opinion contraindicates participation in the trial 6 History or presence of any malignancy or presence of premalignant disease of the uterus or cervix, including endometrial hyperplasia, or (other) sex-steroid sensitive pre-malignancies 7 Known polycystic ovary syndrome 8 Abnormal cervical smear worse than the Bethesda classification atypical squamous cells of undetermined significance (ASC-US) and positive human papilloma virus (HPV) results at screening. (Cervical smear results from within the previous three months prior to screening will be acceptable if the report is available to the investigator; subjects 30 years of age. 12 Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to screening 13 Known or suspected human immunodeficiency virus [HIV] and/or hepatitis infection at screening 14 Prohibited previous medication/contraceptives, i.e. injectable hormonal methods of contraception within the last six months prior to consent, progestin-releasing IUD or contraceptive implant within the last two months prior to consent or anti-retroviral therapy within the last six months prior to consent 15 Long-term treatment (lo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess vaginal bleeding pattern (subject paper diaries).;Secondary Objective: 1. Treatment-emergent adverse events (TEAEs) 2. Effects on vital signs and on clinical laboratory parameters 3. Treatment compliance 4. Subject satisfaction ;Primary end point(s): The primary endpoint will be evaluated by the total number of bleeding/spotting days.;Timepoint(s) of evaluation of this end point: After trial termination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Total number of scheduled bleeding/spotting days 2. Total number of unscheduled bleeding/spotting days 3. Total number of scheduled bleeding/spotting episodes 4. Total number of unscheduled bleeding/spotting episodes 5. Duration of bleeding/spotting episodes 6. Duration of scheduled bleeding/spotting episodes 7. Intensity of bleeding/spotting episodes 8. Rate of absence of all bleeding/spotting 9. Treatment-emergent adverse events (TEAEs) 10. Changes from baseline in vital signs 11. Changes from baseline in clinical laboratory parameters 12. Treatment compliance 13. Subject satisfaction;Timepoint(s) of evaluation of this end point: After trial termination | — |
Countries
Czech Republic, Lithuania, Ukraine
Contacts
Public ContactProject leader
Exeltis France S.A.
Outcome results
None listed