Multicentre, phase II, open label randomised clinical trial to assess the bleeding profile, tolerability and safety associated with the use of three prolonged release formulations containing a combination of dienogest and ethinyl estradiol versus a flexible regimen contraceptive containing drospirenone 3 mg and ethinyl estradiol 20 µg.
Phase of Trial: Phase II
Latest Information Update: 07 Dec 2017
At a glance
- Drugs Ethinylestradiol/dienogest (Primary) ; Drospirenone
- Indications Pregnancy
- Focus Therapeutic Use
- Sponsors Exeltis
- 07 Dec 2017 Planned number of patients changed from 350 to 400.
- 20 Apr 2017 New trial record