Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06188026
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-14
Brief Title:
A Research Study Looking at How the Compound NNC0194-0499 Works With Birth Control Pills in Women Not Able to Bear Children
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
Investigation of the Effect of NNC0194-0499 on Pharmacokinetics of a Combined Oral Contraceptive Ethinylestradiol and Levonorgestrel in Females of Non-childbearing Potential
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-503595-24-00 | REGISTRY | EU CT Number | None |
| U1111-1279-3843 | OTHER | None | None |