An open-label, randomized, parallel arm trial to investigate the pharmacokinetics and pharmacodynamics of NOMAC-E2 and ENG-E2 containing vaginal ring formulations in women of childbearing potential

An open-label, randomized, parallel arm trial to investigate the pharmacokinetics and pharmacodynamics of NOMAC-E2 and ENG-E2 containing vaginal ring formulations in women of childbearing potential - E2 contraceptive vaginal ring study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35882

Enrollment

Registered

2011-07-11

Start date

2011-08-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Anticonceptie contraceptive

Interventions

60 healthy female subjects will have a vaginal ring (NOMAC-E2 or ENG-E2) during 25 days. During the study blood will be sampled on different occasions.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy females, 18-45 years of age, BMI 18-30 kg/m2

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities at screening

Design outcomes

Primary

Measure	Time frame
The objective of this trial is to study how E2, NOMAC and ENG (the test medication) are absorbed, distributed and broken-down by the body during usage of a vaginal ring that releases either NOMAC and E2 or ENG and E2 and to investigate the effect of this vaginal ring on the functioning of the ovaries.	—

Secondary

Measure	Time frame
-	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)