A Research Study Looking Into the Effect of Semaglutide and NNC0480 0389 on Blood Levels of a Birth Control Pill in Woman After Menopause

What Was Tested

In this phase 1 trial, researchers set out to test Semaglutide.

The study will investigate the influence of the combination of semaglutide and NNC0480-0389 on the blood levels of a birth control pill (a combined oral contraceptive consisting of ethinylestradiol and levonorgestrel) and paracetamol.

It had 1 arm (groups): One-sequence cross-over arm (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 27 actual participants took part.

It was open to women only aged from 45 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Postmenopausal female, aged greater than or equal to 45 years at the time of signing informed consent. Body mass index between 20.0 and 29.9 kilogram per meter square (kg/m\^2) (both inclusive).

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol; presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

How the Study Was Run

The set-up was sequential and open-label.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2021-12-13 with completion listed for 2022-08-13.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Maximum concentration of ethinylestradiol at steady state (Cmax,EE,SS), Maximum concentration of levonorgestrel at steady state (Cmax,LN,SS), Area under the paracetamol concentration-time curve for 0-60 minutes following a standardised meal (AUC0-60min,para), Area under the paracetamol concentration-time curve for 0-300 minutes following a standardised meal (AUC0-300min,para) and Maximum observed paracetamol concentration following a standardised meal (Cmax,para).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Semaglutide in 27 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.