Safety, Tolerability and Pharmacokinetics of Estetrol (E4) After Single and Multiple Oral Doses in Healthy Female Volunteers

Contraception Clinical Trial

Official title: An Open-label, Single Center, Randomized, Two Period Study to Characterize the Safety, Tolerability and Pharmacokinetics (PK) of Estetrol (E4) After Single and Multiple Oral Doses in Healthy Female Volunteers

Status Completed

Clinical Trial Summary

Estetrol (E4) is being developed in two indications supporting women health care: first E4 is combined with a progestin, [drospirenone (DRSP)] and is used as a new combined oral contraceptive (COC) for the prevention of pregnancy and secondly, E4 is used alone as new hormone replacement therapy (HRT) for the treatment of menopause related symptoms.

The current clinical trial is designed to collect more detailed information about the PK profile, safety and tolerability of different dosages of E4, given orally as a solid tablet.

Clinical Trial Description

This is an open-label, single-center, randomized, two-period, single and multiple oral dose study in 27 healthy female volunteers.

After a screening period, eligible subjects (n=27) will receive a single oral dose of 5, 15, or 45 mg E4 (Period 1). After at least 14-day washout, 18 subjects will continue the study (Period 2). They will receive 15 mg E4 once daily for 14 consecutive days. ;

Related Conditions & MeSH terms

• Contraception
• Menopause

• NCT number: NCT03075956
• Study type: Interventional
• Source: Estetra
• Status: Completed
• Phase: Phase 1
• Start date: January 31, 2017
• Completion date: August 2, 2017