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
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.
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.
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