NCT03075956

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Estetra · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Contraception
• Menopause

Interventions

Type	Name	Description
DRUG	5 mg E4 single-dose	A single oral dose of 5 mg E4 will be administered during Period 1 of the study.
DRUG	15 mg E4 single-dose	A single oral dose of 15 mg E4 will be administered during Period 1 of the study.
DRUG	45 mg E4 single-dose	A single oral dose of 45 mg E4 will be administered once orally during Period 1 of the study
DRUG	15 mg E4 multiple-dose	15 mg E4 will be administered once daily orally for 14 consecutive days during Period 2 of the study

Timeline

• Start date: 2017-01-31
• Primary completion: 2017-08-02
• Completion: 2017-08-02
• First posted: 2017-03-09
• Last updated: 2017-09-08

Locations

1 site across 1 country: Bulgaria