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Contraceptive Efficacy, Tolerance and Acceptability of a Benzalkonium Chloride Spermicide Cream In Women Aged Over 40 Years of Age

NCT03102450 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2020-02-26

No results posted yet for this study

Summary

In spite of many advantages of spermicides, there is no contraceptive efficacy study conducted with any spermicide in women aged over 40 years. That is why the aim of this study is to evaluate contraceptive efficacy, tolerance and acceptability of a spermicide with benzalkonium chloride (Pharmatex® cream) in women aged over 40 years.

Conditions

  • Contraception

Interventions

DRUG

Benzalkonium Chloride Spermicide Cream

One dose of Pharmatex vaginal cream (benzalkonium chloride) must be used systematically before each intercourse, regardless of the cycle period, even during menstrual periods. In case of repeated acts of intercourse, an additional dose of cream must be used before each new act. Duration of treatment : 6 months (12 months optional)

Sponsors & Collaborators

  • ITEC Services

    collaborator OTHER

  • Laboratoire Innotech International

    lead INDUSTRY

Principal Investigators

  • David Serfaty, MD · 9 rue Villersexel 75007 PARIS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-26
Primary Completion
2019-10-17
Completion
2019-10-17

Countries

  • France
  • Russia

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 NCT03102450 on ClinicalTrials.gov