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

What this trial studies

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.

Conditions in scope

• Diabetes Mellitus, Type 2

Interventions

• NNC0519-0130 (Drug) — NNC0519-0130 will be administered subcutaneously.
• Levonorgestrel + Ethinylestradiol (Drug) — Levonorgestrel + Ethinylestradiol will be administered orally.
• Paracetamol (Drug) — Paracetamol will be administered orally.

Who can join

Women only · Up to 45 Years

Inclusion criteria

• 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.

Exclusion criteria

• Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
• Glycated haemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimoles per mole (mmol/mol)) at screening.
• 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).

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE1
• Start date: 2024-07-18
• Primary completion: 2025-09-10
• Last update posted: 2026-03-12
• First posted: 2024-07-22

Sponsor & contact

Lead sponsor: Novo Nordisk A/S (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state (Day 8)
  Measured in hours picograms per milliliter (h*pg/mL).
• Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state (Day 188)
  Measured in h*pg/mL.
• Area under the levonorgestrel plasma concentration time curve during a dosing interval at steady state (Day 8)
  Measured in h*pg/mL.
• Area under the levonorgestrel plasma concentration time curveduring a dosing interval at steady state (Day 188)
  Measured in h*pg/mL.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.