CompletedPhase 1

A Research Study Looking Into the Effect of NNC0519-0130 on Blood Levels of a Birth Control Pill and Emptying of the Stomach in Women After Menopause

Germany47 participantsStarted 2024-07-18

Plain-language summary

The purpose of the study is to investigate if NNC0519-0130 affects the blood levels of a birth control pill that contains the two hormones ethinylestradiol and levonorgestrel. The study will also look into if NNC0519-0130 affects how fast stomach is emptied. Participants will get the new study medicine NNC0519-0130 and will also get birth control pills and paracetamol. The study will last for about 35 weeks.

Who can participate

Age range45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Presence or risk of venous thromboembolism or arterial thromboembolism, e.g., history of migraine with focal neurological symptoms or transitory ischemic attacks.
✕. Undiagnosed vaginal bleeding.
✕. Presence or history of breast cancer.
✕. Presence or history of liver tumours (benign or malignant).
✕. Positive family history of arterial thromboembolism and/or venous thromboembolism (ever in a sibling or parent especially at relatively early age e.g. below 50).
✕. Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and anti-phospholipid antibodies (anticardiolipinantibodies, lupus anticoagulant).
✕. Known hereditary or acquired predisposition to venous thromboembolism, such as Activated Protein C (APC) resistance (including factor V Leiden), antithrombin III deficiency, protein C deficiency or protein S deficiency.
✕. Dyslipoproteinaemia.

What they're measuring

Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state

Timeframe: Day 8

Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state

Timeframe: Day 188

Area under the levonorgestrel plasma concentration time curve during a dosing interval at steady state

Timeframe: Day 8

Area under the levonorgestrel plasma concentration time curveduring a dosing interval at steady state

Timeframe: Day 188

Trial details

NCT IDNCT06513104

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-10

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials

Plain-language summary

Who can participate

Age range45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Presence or risk of venous thromboembolism or arterial thromboembolism, e.g., history of migraine with focal neurological symptoms or transitory ischemic attacks.
✕. Undiagnosed vaginal bleeding.
✕. Presence or history of breast cancer.
✕. Presence or history of liver tumours (benign or malignant).
✕. Positive family history of arterial thromboembolism and/or venous thromboembolism (ever in a sibling or parent especially at relatively early age e.g. below 50).
✕. Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and anti-phospholipid antibodies (anticardiolipinantibodies, lupus anticoagulant).
✕. Known hereditary or acquired predisposition to venous thromboembolism, such as Activated Protein C (APC) resistance (including factor V Leiden), antithrombin III deficiency, protein C deficiency or protein S deficiency.
✕. Dyslipoproteinaemia.

What they're measuring

Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state

Timeframe: Day 8

Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state

Timeframe: Day 188

Area under the levonorgestrel plasma concentration time curve during a dosing interval at steady state

Timeframe: Day 8

Area under the levonorgestrel plasma concentration time curveduring a dosing interval at steady state

Timeframe: Day 188