A randomized, double-blind, placebo-controlled, parallel, single center study to investigate the pharmacokinetics, safety, and tolerability of Estetrol (E4) in combination with Drospirenone (DSRP) after single and multiple dosing in healthy women.

A randomized, double-blind, placebo-controlled, parallel, single center study to investigate the pharmacokinetics, safety, and tolerability of Estetrol (E4) in combination with Drospirenone (DSRP) after single and multiple dosing in healthy women. - E4/DRSP single and multiple dose PK and early QT study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43025

Enrollment

Registered

2016-03-30

Start date

2016-04-14

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Zwangerschapspreventie. Prevention of pregnancy.

Interventions

Group Dose Level E4 (mg) Dose Level DRSP (mg) Dosage Group 1 15 3 therapeutic E4/DRSP dose level Group 2 30 6 2 times therapeutic E4/DRSP dose level Group 3 60 12 4 times therapeutic E4/DRSP dose

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy female subjects 18-50 years, inclusive BMI 18.0-35.0 kg/m2, inclusive non-smokers

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
To investigate the pharmacokinetics (PK) of single and multiple doses of estetrol (E4) in combination with drospirenone (DRSP) in healthy women	—

Secondary

Measure	Time frame
To investigate the safety and tolerability of single and multiple doses of E4 in combination with DRSP in healthy women. To define the effect of E4 in combination with DRSP on QT interval corrected with Fridericia*s formula (QTcF) in healthy women using exposure-response analysis. To define the effect of E4 in combination with DRSP on heart rate (HR), PR, and QRS in healthy women.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)