This is an open-label, multi-centre, comparative study in young, healthy, female volunteers of reproductive age. Primary objective: \- To investigate the effect of 2 dosages of estetrol combined with P1 or P2, on vaginal bleeding patterns (cycle control), in comparison with a combined oral contraceptive containing estradiol valerate and dienogest Secondary objectives: * To investigate ovulation inhibition * To investigate the effect on SHBG * To assess pregnancy rate * To evaluate subject satisfaction, dysmenorrhoea, acne, and body weight * To investigate return of menstruation after treatment * To evaluate general safety and acceptability
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
396
6 treatment cycles each consisting of 28 days of oral administration as follows: * Days 1-24: one estetrol tablet and one P1 tablet per day * Days 25-28: two placebo tablets per day
6 treatment cycles each consisting of 28 days of oral administration as follows: * Days 1-24: one estetrol tablet and one P2 tablet per day * Days 25-28: two placebo tablets per day
6 treatment cycles each consisting of 28 days of oral administration as follows: * Days 1-26: one tablet of Estradiol valerate/dienogest per day * Days 26-28: one placebo tablet per day
Mehiläinen Helsinki
Helsinki, Finland
Väestöliitto Helsinki
Helsinki, Finland
YTHS Jyvaskyla
Jyväskylä, Finland
Laboratorio Simpanen
Kuopio, Finland
Terveystalo Kuopio
Kuopio, Finland
YTHS Kuopio
Kuopio, Finland
Väestöliitto Oulu
Oulu, Finland
Tampereen Lääkärikeskus Oy
Tampere, Finland
YTHS Tampere
Tampere, Finland
Väestöliitto Turku
Turku, Finland
Recording of vaginal bleeding events (diary) as a measure of Cycle control
Time frame: 6 cycles of 28 days
Measurement of pregnandiol glucuronide in urine as a measure of Ovulation inhibition
Time frame: 6 cycles of 28 days
Patient Reported Outcome questionnaire as a measure of Subject satisfaction
Time frame: 6 cycles of 28 days
Contacts patient-investigator to document Return of menstruation
(only in case the patient does not start up a new hormonal contraceptive method or in case of pregnancy wish)
Time frame: for up to 1 year follow-up
Recording of adverse events, physical examination and laboratory parameters as a measure of Safety and Tolerability
Time frame: up to 8 months
Measurement of SHBG in blood samples to assess the effect of treatment on SHBG
Time frame: 6 cycles of 28 days
Reporting of in-treatment pregnancies as a measure of pregnancy rate
Time frame: 6 cycles of 28 days
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