Completed PHASE1 INTERVENTIONAL 1-arm NCT01597986

Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone

A Phase 1, Open Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone

Sponsor: Astellas Pharma Global Development, Inc.

Conditions Healthy Volunteers Pharmacokinetics of Ethinyl Estradiol and Norethindrone Pharmacokinetics of Isavuconazole

Interventions Oral Contraceptive (ethinyl estradiol / norethindrone) isavuconazole

Updated 6 times since 2017 Last updated: Jul 12, 2012 Started: Apr 30, 2012 Primary completion: Jun 30, 2012 Completion: Jun 30, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Healthy Volunteers and Pharmacokinetics of Ethinyl Estradiol and Norethindrone and is currently completed. Astellas Pharma Global Development, Inc. leads this study, which shows 6 recorded versions since 2012 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Apr 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Astellas Pharma Global Development, Inc.
Basilea Pharmaceutica International Ltd

Data source: Astellas Pharma Inc

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Miami, United States