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Tolerability and Pharmacokinetic Study of Econazole Nitrate Plus Benzydamine HCl Vaginal Pessary

NCT02720783 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2017-02-07

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the local tolerability of the new Econazole/Benzydamine pessary, in comparison with Econazole and Benzydamine stand-alone products and placebo. Pharmacokinetics of the study products after single and multiple applications o.d. for 3 days, overall local and general tolerability, safety and comfort of use will also be evaluated.

Conditions

  • Healthy Women

Interventions

DRUG

Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary

Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary

DRUG

Placebo plus Econazole nitrate 150 mg vaginal pessary

DRUG

Placebo plus Benzydamine HCl 6 mg vaginal pessary

DRUG

Placebo vaginal pessary

Sponsors & Collaborators

  • Cross Research S.A.

    collaborator INDUSTRY

  • Aziende Chimiche Riunite Angelini Francesco S.p.A

    lead INDUSTRY

Principal Investigators

  • Milko Radicioni, MD · CROSS Research S.A. Phase I Unit

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-04
Primary Completion
2016-10-12
Completion
2016-10-12

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02720783 on ClinicalTrials.gov