E4/DRSP Ovarian Function Inhibition Study

Prevention of Pregnancy Clinical Trial

Official title: A Single-center, Randomized, Open-label, Two-arm Study to Evaluate the Ovarian Function Inhibition of a Monophasic Combined Oral Contraceptive (COC) Containing 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP) and a Monophasic COC Containing 20mcg Ethinylestradiol (EE)/3 mg DRSP (YAZ®), Administered Orally Once Daily in a 24/4 Day Regimen for Three Consecutive Cycles

Status Completed

Clinical Trial Summary

A combined oral contraceptive (COC) containing 15 mg E4 and 3 mg DRSP administered for 24 days followed by 4 placebo tablets, is being evaluated for further development. This study will investigate the effect of this COC on ovarian function inhibition, levels of serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol (E2) and progesterone during 3 treatment cycles in comparison with the reference COC 20 mcg EE/3 mg DRSP.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Prevention of Pregnancy

• NCT number: NCT03091595
• Study type: Interventional
• Source: Estetra
• Status: Completed
• Phase: Phase 2
• Start date: February 7, 2017
• Completion date: June 8, 2018