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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1279-3843 | Other Identifier | World Health Organization (WHO) | |
| 2023-503595-24-00 | Registry Identifier | EU CT Number |
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The study will investigate the influence of NNC0194-0499 on the blood levels of the two components of a birth control pill, Microgynon®. Participants will get the birth control pill in form of tablets in two periods of 8 days each.
Participants will get NNC0194-0499 as injection under the skin of their thigh. The injections will be given once weekly for 5 weeks.
The study will last for about 11 to 15 weeks, depending on the length of the screening period.
Participants will have to stay overnight at the study centre (2 nights and 4 nights, respectively) Only healthy women who are not able to bear children can take part in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | All participants will be exposed to both interventions in a defined sequence. OC 8 days, NNC0194-0499 4 weeks, OC/NNC0194-0499 combined 1 week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0194-0499 | Drug | Once a week for 5 weeks as an injection in dose of 30 mg. The injection will be given under the skin |
|
| Measure | Description | Time Frame |
|---|---|---|
| (AUC0-24h,EE,SS), area under the ethinylestradiol plasma concentration-time curve during a dosing interval at steady state | h-pg/mL | Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose) |
| (AUC0-24h,LN,SS), area under the levonorgestrel plasma concentration-time curve during a dosing interval at steady state | h-pg/mL | Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| (Cmax,EE,SS), maximum concentration of ethinylestradiol at steady state | pg/mL | Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose) |
| (Cmax,LN,SS), maximum concentration of levonorgestrel at steady state |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | 8010 | Austria |
"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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single-centre, one-sequence cross-over, open-label study
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| ethinylestradiol/levonorgestrel | Drug | Oral contraceptive is taken as tablet daily composed of 30 μg ethinylestradiol and 150 μg levonorgestrel. |
|
pg/mL
| Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose) |
| (tmax,EE,SS), time to maximum concentration of ethinylestradiol at steady state | hours | Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose) |
| (tmax,LN,SS), time to maximum concentration of levonorgestrel at steady state | hours | Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose) |
| Number of treatment emergent adverse events (TEAEs) | Number of events | Day 1 to Day 8, and Day 31 to Day 38. |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
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