A single dose, randomized, three arm, two-way, cross-over study to assess the effect of food on the pharmacokinetics of the commercial NOMAC-E2 tablet formulation and of the phase 3 pivotal clinical batches (Protocol No. P06456)

A single dose, randomized, three arm, two-way, cross-over study to assess the effect of food on the pharmacokinetics of the commercial NOMAC-E2 tablet formulation and of the phase 3 pivotal clinical batches (Protocol No. P06456) - NOMAC-E2 food effect trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35968

Enrollment

Registered

2011-04-27

Start date

2011-05-17

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Gecombineerde orale hormonale anticonceptie birth control Contraceptive

Interventions

Active substance: NOMAC-E2

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy postmenopausal females Age : 45-70 years, inclusive BMI : 18 - 32, inclusive

Exclusion criteria

Exclusion criteria: Suffering from : hepatitis B, cancer or HIV-Aids. In case of participation in more then two other drug study within 60 days before the start of the study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.0 liters of blood in the 10 months preceding the start of the study.

Design outcomes

Primary

Measure	Time frame
- Pharmacokinetics - Safety	—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)