Completed PHASE1 INTERVENTIONAL 4-arm NCT02713893

Tolerability and Pharmacokinetic Study of Econazole Nitrate and Benzydamine HCl Intravaginal Cream

A Phase I Study of a Novel Intravaginal Antimycotic Cream (Econazole Nitrate 1% Plus Benzydamine HCl 0.12%) Administered Once Daily for 15 Days to Healthy Women

Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A

Conditions Healthy

Interventions Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream Placebo intravaginal cream Placebo plus Benzydamine HCl 0.12% intravaginal cream Placebo plus Econazole nitrate 1% intravaginal cream

Updated 6 times since 2017 Last updated: Jan 15, 2018 Started: Sep 30, 2015 Primary completion: Jun 30, 2016 Completion: Jun 15, 2016

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 and is currently completed. Aziende Chimiche Riunite Angelini Francesco S.p.A leads this study, which shows 6 recorded versions since 2015 — 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 2018 — Jun 2018 [monthly]

Completed PHASE1

Status: Recruiting → Completed

▶ Show 1 earlier version

Jan 2017 — Feb 2018 [monthly]

Recruiting PHASE1

First recorded

Sep 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Aziende Chimiche Riunite Angelini Francesco S.p.A
Cross Research S.A.

Data source: Aziende Chimiche Riunite Angelini Francesco S.p.A

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

Study Locations

• Arzo, Switzerland