NCT01221831

Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2

A Randomised Open-label Multi-centre Comparative Study to Evaluate Cycle Control of 2 Dosages of Estetrol Combined With Either P1 or P2, Compared to a Combined Oral Contraceptive Containing E2V and DNG

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 396 (actual)
• Sponsor: Estetra · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	estetrol, P 1 and placebo tablets	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
DRUG	estetrol, P2 and placebo tablets	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
DRUG	Estradiol valerate, dienogest and placebo tablets	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

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2010-10-15
• Last updated: 2012-09-14

Locations

10 sites across 1 country: Finland