Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-31 @ 2:09 AM
Study NCT ID:
NCT02215395
Status:
COMPLETED
Last Update Posted:
2017-08-15
First Post:
2014-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label Study to Evaluate the Effects of Concurrent Administration of Vaginal Antimycotic Medication Miconazole Nitrate on the Pharmacokinetics of Nestorone and Ethinyl Estradiol Delivered by a Contraceptive Vaginal Ring in Normal Ovulating Women
Sponsor:
Population Council
Organization:
Study Overview
Official Title:
Phase 1, Open-label Study to Evaluate the Effects of Concurrent Administration of Vaginal Antimycotic Medication (Miconazole Nitrate) on the Pharmacokinetics of Nestorone and Ethinyl Estradiol Delivered by a Contraceptive Vaginal Ring Releasing a Daily Dose of 150 ug of NES and 15 ug of EE
Status:
COMPLETED
Status Verified Date:
2017-08
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:
To evaluate the pharmacokinetics (PK) of EE and NES released from the CVR in the presence of a single dose and multiple doses of antimycotic co-medication (miconazole nitrate suppository or cream).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: