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Microbiological Impact of an Intimate Cream and Its Suitability to Contribute to the Feeling of Softness and Freshness in the Intimate Area of Women

NCT02162160 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-11-26

No results posted yet for this study

Summary

Generate more information on the use of the Probiotic Intimate Crème regarding feeling of dryness and freshness in the intimate area, as well as to evaluate the Lactobacillus flora and presence of coliform bacteria in respect to E. coli in the intimate area of women before use of the crème and at the end of a 10 days crème-usage (day 8-10), as well as 10 days after (9-11 days) finished crème-usage.

The hypothesis is that lactobacilli can survive in the intimate area of postmenopausal women with use of a probiotic creme.

Conditions

  • Post Menopausal Dryness in the Intimate Area of Women

Interventions

DEVICE

probiotic creme

Probiotic creme applied

DRUG

Placebo

Creme without probiotics applied in same manner

Sponsors & Collaborators

Principal Investigators

  • Helena Kopp Kallner, MD, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Companies

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 NCT02162160 on ClinicalTrials.gov