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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1294-3433 | Other Identifier | World Health Organization (WHO) | |
| 2023-507973-16 | Other Identifier | European Medical Agency (EMA) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0519-0130 + OC+ paracetamol | Experimental | All participants will initiate treatment with paracetamol (once) and oral contraceptive (Levonorgestrel + Ethinylestradiol) treatment only followed by a period with NNC0519-0130 treatment only, thereafter a period with NNC0519-0130, paracetamol (once) and oral contraceptive treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0519-0130 | Drug | NNC0519-0130 will be administered subcutaneously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state | Measured in hours picograms per milliliter (h*pg/mL). | Day 8 |
| Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state | Measured in h*pg/mL. | Day 188 |
| Area under the levonorgestrel plasma concentration time curve during a dosing interval at steady state | Measured in h*pg/mL. | Day 8 |
| Area under the levonorgestrel plasma concentration time curveduring a dosing interval at steady state | Measured in h*pg/mL. | Day 188 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum ethinylestradiol plasma concentration at steady state | Measured in picograms per milliliter (pg/mL). | Day 8 and Day 188 |
| Maximum levonorgestrel plasma concentration at steady state | Measured in pg/mL. |
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Inclusion Criteria:
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:
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.
Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International GmbH | Berlin | 14050 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Levonorgestrel + Ethinylestradiol |
| Drug |
Levonorgestrel + Ethinylestradiol will be administered orally. |
|
| Paracetamol | Drug | Paracetamol will be administered orally. |
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| Day 8 and Day 188 |
| Area under the paracetamol concentration-time curve for 0-300 minutes following a standardised meal | Measured in hours micrograms per milliliter (h*μg/mL). | Day 1 and Day 181 |
| Area under the paracetamol concentration-time curve for 0-60 minutes following a standardised meal | Measured in h*μg/mL. | Day 1 and Day 181 |
| Maximum paracetamol plasma concentration following a standardised meal | Measured in micrograms per milliliter (μg/mL). | Day 1 and Day 181 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| D004997 | Ethinyl Estradiol |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009651 | Norpregnatrienes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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