Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2
Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
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