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 range

45 Years

Sex

FEMALE

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

45 Years

Sex

FEMALE

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.

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