Contraception Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel, Single Center Study to Investigate the Pharmacokinetics, Safety, Tolerability, and QT Concentration-effect Modelling of Estetrol in Combination With Drospirenone After Single and Multiple Dosing in Healthy Women
This study is conducted to evaluate the effect of single and multiple therapeutic and supratherapeutic oral doses of E4/DRSP combinations on PK parameters, safety, tolerability and on cardiac repolarization, as detected by QT interval corrected with Fridericia's formula (QTcF).
This will be a randomized, double-blind, placebo-controlled, parallel, single center study
in healthy female subjects. A total of 42 female subjects will be enrolled in 3 groups of 14
subjects each. A potential fourth group of 14 healthy female subjects may be added. In each
group, subjects will be randomized in a 2.5 to 1 ratio between active (n=10) and placebo
(n=4).
Subjects will receive a single dose on Day 1 and, after a washout of at least 14 days,
multiple doses on 14 consecutive days from Days 15 to 28.
Group 1 and Group 2 may be dosed in parallel. After completion of Group 1 and Group 2, a
Dose Escalation Report (DER), including PK data up to at least 24 hours post-last dose, will
be prepared by the Principal Investigator (PI). Escalation to the planned dose level of 60
mg E4/12 mg DRSP will only proceed if the safety and tolerability of the dose levels of 15
mg E4/3 mg DRSP and 30 mg E4/6 mg DRSP up to 24 hours post-last dose, are acceptable to the
PI and the Sponsor and, if deemed necessary by the Independent Ethics Committee (IEC)
following their review of the protocol, after a statement of no objection of the DER from
the IEC.
After completion of Group 3, a second DER, including PK data, will be prepared by the PI. If
in Group 3 the expected exposure level of approximately 4 times the exposure of Group 1 is
not achieved, and treatment in Group 3 is well tolerated, an additional group with 14
subjects may be enrolled, using a dose level that is estimated to result in at least 4 times
the exposure after administration of the 15 mg E4/3 mg DRSP therapeutic dose.
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