Fact CheckerSign in

NCT06513104CompletedPhase 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

Investigation of the Effect of NNC0519-0130 on the Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) and Gastric Emptying in Healthy Postmenopausal Females

Source: ClinicalTrials.gov · Last updated 12 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
47 (actual)
First submitted
16 Jul 2024
Start date
18 Jul 2024
Primary completion date
10 Sept 2025
Lead sponsor
Novo Nordisk A/S
NCT number
NCT06513104
EU CT number
2023-507973-16-00
EudraCT number
2023-507973-16

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 47
  • From 18 Jul 2024 to the primary completion date, 10 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic cytochrome P450 (CYP) pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. Exceptions are routine vitamins, occasional use of paracetamol, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.
  • Use of hormone replacement therapy within 4 weeks before screening or intention to initiate treatment with hormone replacement therapy during the study.

Other illness

  • Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
  • Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

Lab values

  • Glycated haemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimoles per mole (mmol/mol)) at screening.

Age

  • Any contraindications for the use of the oral contraception used in the study according to the Microgynon Summary of Product Characteristics, including:
    • 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.

Who the study is looking for

  • Postmenopausal female.
  • Age greater than or equal to (≥)45 years at the time of signing informed consent.
  • Body weight ≥ 60 kilogram (kg).
  • Body mass index (BMI) between 27.0 and 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
  • Considered to be otherwise healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Parexel International GmbH
Coordinator of this site? Confirm its status
BerlinGermanyCompleted

This page is information, not medical advice. Discuss any trial with your doctor.