Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-01-03 @ 10:20 PM
Study NCT ID:
NCT03353857
Status:
COMPLETED
Last Update Posted:
2020-04-15
First Post:
2017-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-drug Interaction Between Rifampicin and Progestins/Ethinylestradiol and Midazolam
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
Open-label, Randomized, Fixed Sequence Cross-over Study With Five Parallel Treatment Arms and Three Treatment Periods to Quantify the Drug-drug Interactions of Two Rifampicin Dose Strengths on Four Progestins and a Fixed Progestin-ethinylestradiol Combination Compared With Midazolam in Healthy Post-menopausal Women
Status:
COMPLETED
Status Verified Date:
2020-04
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:
Quantify the effect of a probe CYP3A4 inducer (Rifampicin) on the pharmacokinetics of levonorgestrel, norethindrone, desogestrel, dienogest, drospirenone,estradiol and midazolam
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-002792-26 | EUDRACT_NUMBER | None | View |