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OpenTrials
Completed

NCT Number: NCT02434887

Clinical Study for Perceived Effectiveness Evaluation of Moisturizing Action of Intimate Use Product in Postmenopausal Women

The purpose of this study is to verify the effectiveness of the investigational product through Subjective Assessment and answered by volunteers.

Completed

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Key information

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female aged between 45 to 65 years old
  • Sexually active volunteers, with a minimum of 1 intercourse per week
  • In menopause for at least 6 months;
  • Intact skin in the product analysis region;
  • No prior reactions to topical products
  • Reading, understanding, agreement and signature of the informed consent form

Exclusion criteria

  • Use of anti-inflammatory and immunosuppressive ( in the last 30 days and during the study)
  • Active skin diseases (local or disseminated) in the evaluation área;
  • 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.

Treatment and study plan

KL029 Intimate Lubricant Gel

Device

Primary outcomes

  1. Evaluation of the product's efficiency as a moisturizer through subjective evaluation

    Time frame: 40 days

Sponsors and collaborators

Lead sponsor

Kley Hertz S/A

Industry

Registry information

Acronym: CLIN ST EF EV

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 6, 2015
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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