drugset / Trial / NCT01221831
Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2010-09
- Primary completion
- 2011-09
- Completion
- 2011-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dienogest | Small molecule | — | Oral |
| Subject | ESTETROL ANHYDROUS | Other / unclassified | — | Oral |
| Subject | P1 | Unknown | — | Oral |
| Subject | P2 | Unknown | — | Oral |
| Comparator | estradiol valerate | Unknown | — | Oral |
Indications
No indication recorded.