A human phase 0, microdose pharmacokinetic study of [14C]-Org 201745-0, [14C]-Org 244378-0 and [14C]-Org 245021-0 in post-menopausal female volunteers

A human phase 0, microdose pharmacokinetic study of [14C]-Org 201745-0, [14C]-Org 244378-0 and [14C]-Org 245021-0 in post-menopausal female volunteers - [14C]-Org 201745, [14C]-Org 244378 and [14C]-Org 245021 Microdosing Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31864

Enrollment

Registered

2007-11-16

Start date

2007-12-16

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

anticonceptie contraception family planning

Interventions

[14C]-Org 201745, [14C]-Org 244378 and [14C]-Org 245021 microdose

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 45-70 years of age amenorrhoe for 18 months

Exclusion criteria

Exclusion criteria: history of significant disease

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics : plasma drug concentrations; pharmacokinetic parameters in plasma: Cmax, Tmax, AUC0-inf, t1/2; to perform pharmacokinetic analysis of urine samples will be decided later after analysis of plasma samples Safety : adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination.	—

Secondary

Measure	Time frame
none	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)