NCT02215395

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Population Council · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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).

Conditions

• Antifungal Drug Adverse Reaction

Interventions

Type	Name	Description
DRUG	NES/EE CVR	Concurrent administration of vaginal antimycotic medication (Miconazole Nitrate) on the pharmacokinetics of Nestorone (NES) and ethinyl estradiol (EE) delivered by a contraceptive vaginal ring (CVR)

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-08-13
• Last updated: 2017-08-15

Locations

1 site across 1 country: United States