NCT02441647

Completed

Clinical Study to Prove Safety in Use (Irritability and Sens...

Kley Hertz S/A Source

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Other study identifiers

Sponsor study identifier

KLEY HERTZ-003

Study Type

interventional

Actual enrollment (reported)

33

Locations

0 countries

Sites

N/A

Timeline

Study Start

June 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2015

Actual (reported)

Study Completion

July 2015

Actual (reported)

Brief Summary

The purpose of this study is to check the safety under normal conditions of use through the emergence of signs of irritability and sensitization of the genital mucosa.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 33 participants
Study completion date: July 2015
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 15, 2015
Actual (reported)
First Posted
May 12, 2015
Actual (reported)
Study Start
June 2015
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
June 2015
Actual (reported)
Study Completion
July 2015
Actual (reported)

Last Updated: November 10, 2015
Status Verified: November 2015
Last Update Submitted: November 9, 2015

Conditions

Female Dry Genital Mucosa

Outcome Measures

Primary Outcomes (1)

Emergence of signs of irritability and sensitization in the genital mucosa through Wilcoxon test
For the safety assessment, the variables will be evaluated for each experimental period using one-tailed Wilcoxon test to investigate the following hypotheses: H0: The median of the results of the variable under study is zero (no irritation) H1: The median of the results of the variable under study is greater than zero (no irritation) The Wilcoxon test is used because it is the ideal to compare variables collected with ordinal scale with a reference value. In this study, the reference value is zero (no irritation). The expectation is the absence of positive safety, ie higher scores than zero. If there are positive evidence of (mild, moderate or severe) for parameters erythema, peeling,blistering and swelling, the results are statistically evaluated.
40 days

Study Arms (1)

Experimental group

EXPERIMENTAL

Device: KL029 Intimate Lubricant Gel

Interventions

KL029 Intimate Lubricant GelDevice

Experimental group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age25 Years - 55 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Female
Age between 25 to 55 years old

Sponsors & Collaborators

Kley Hertz S/A
Industrylead

Enrollment

33 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: SINGLE
Who Masked: PARTICIPANT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 15, 2015

First Posted

May 12, 2015

Study Start

June 2015

Date type not reported

This date has not been verified as actual or estimated.

Regular Menstrual Cycle

Intact skin in product analysis área

No prior reactions to topical products

Being a user of products from the same category

Reading, understanding, agreement and signature of the informed consent form

You may not qualify if:

Pregnancy or risk of pregnancy
Lactation
Use of anti-inflammatory and immunosuppressive from 30 days up to three months prior to selection;
Diseases that cause imune suppression;
Endocrine disorders such as thyroid, ovarian or adrenal gland disorders;
Any infection in the region where the product will be analyzed diagnosed at enrollment;
Other conditions considered by the investigator physician as reasonable for the disqualification of the individual's participation in the study.

Contact the study team to confirm eligibility.

Primary Completion

June 2015

Actual (reported)

Study Completion

July 2015

Actual (reported)

Last Updated

November 10, 2015

Record last verified: 2015-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02441647
Data provider: ClinicalTrials.gov
Source updated: 2015-11-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:02 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Experimental group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record