NCT03007615

Unknown

Dermal and Gynecological Acceptability (Irritability and Sen...

Kley Hertz S/A Source

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Other study identifiers

Sponsor study identifier

Kley Hertz 007

Study Type

interventional

Estimated enrollment

33

Locations

0 countries

Sites

N/A

Timeline

Study Start

January 2017

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2017

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

Not reported

Date not reported

Brief Summary

To evaluate the safety of an investigational product through the verification of signs of irritability and sensitization of the genital mucosa, as well as the instrumental moisturizing efficacy by TEWL and barrier integrity analysis, in addition to the efficacy perceived by the volunteers.

Registry Overview

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

Recruitment status: unknown
Estimated enrollment: 33 participants
Study completion date: Not reported
Date not reported
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

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
December 29, 2016
Actual (reported)
Study Start
January 2017
Date type not reported
This date has not been verified as actual or estimated.
First Posted
January 2, 2017
Actual (reported)
Primary Completion
February 2017
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: January 2, 2017
Status Verified: December 2016
Last Update Submitted: December 29, 2016

Conditions

Female Dry Genital Mucosa

Outcome Measures

Primary Outcomes (1)

Evaluation of the product's efficiency as a moisturizer through subjective evaluation
30 days

Study Arms (1)

Experimental group

EXPERIMENTAL

Other: Intimate Lubricant Gel

Interventions

Intimate Lubricant GelOther

Experimental group

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

Eligibility Criteria

Age45 Years - 65 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Healthy female sex with active sex life;
Age group: between 45 and 65 years old;

Sponsors & Collaborators

Kley Hertz S/A
Industrylead

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

December 29, 2016

First Posted

January 2, 2017

Study Start

January 2017

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2017

Estimated (date passed)

Menopause for at least six months;

Whole skin in the region of product analysis;

No history of reaction to products of the same category

Understanding, agreement and signature of the Term of Free and Informed Consent.

You may not qualify if:

Gestation or risk of gestation;
Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study);
Active cutaneous pathologies (local and / or disseminated) in the evaluation area;
Pathologies that cause suppression of immunity, such as diabetes, HIV, etc.;
Endocrine pathologies such as thyroid disorders, ovarian or adrenal gland disorders;
Other conditions considered by the investigating physician as reasonable for disqualification of the individual from the study participation.

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

January 2, 2017

Record last verified: 2016-12

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: NCT03007615
Data provider: ClinicalTrials.gov
Source updated: 2017-01-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:43 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Experimental group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Design

Study Record Dates

You may not qualify if:

Source record