Parexel International GmbH
Berlin, 14050, Germany
NCT Number: NCT06513104
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.
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Notify MeUp to 45 year
Female
Interventional
Phase 1
Berlin, 14050, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NNC0519-0130 will be administered subcutaneously.
Levonorgestrel + Ethinylestradiol will be administered orally.
Paracetamol will be administered orally.
Time frame: Day 8
Measured in hours picograms per milliliter (h*pg/mL).
Time frame: Day 188
Measured in h*pg/mL.
Time frame: Day 8
Measured in h*pg/mL.
Time frame: Day 188
Measured in h*pg/mL.
Time frame: Day 8 and Day 188
Measured in picograms per milliliter (pg/mL).
Time frame: Day 8 and Day 188
Measured in pg/mL.
Time frame: Day 1 and Day 181
Measured in hours micrograms per milliliter (h*μg/mL).
Time frame: Day 1 and Day 181
Measured in h*μg/mL.
Time frame: Day 1 and Day 181
Measured in micrograms per milliliter (μg/mL).
Novo Nordisk A/S
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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