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OpenTrials
Completed

NCT Number: NCT00778934

In-Home Use Study to Evaluate Use of an Intimate Health Product in Females

The purpose of this study is to evaluate the effects of an intimate health product on sexual experience in females.

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Key information

Conditions

Coitus Behavior Sexual Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center of Marital and Sexual Health of South Florida, West Palm Beach, Florida, United States

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About this study

Study to evaluate consumer perceptions of a cosmetic intimate health product on sexual experience in females, using a validated psychometric questionnaire.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Normal, healthy females >18 years of age
  • In committed heterosexual relationship for >6months
  • Of adequate sexual functioning
  • On acceptable method of birth control

Exclusion criteria

  • Pregnant or breastfeeding
  • Allergy to product ingredients
  • Irritation or infection in genital area
  • Unstable or uncontrolled medical condition

Treatment and study plan

Intimate Health Gel

Other

Intimate Health Gel

Other names: Not marketed yet

Primary outcomes

  1. To assess the effect of product on sexual enhancement by comparing baseline questionnaire responses to the end of study questionnaire responses

    Time frame: End of study (3 weeks after baseline visit)

Secondary outcomes

  1. Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.

    Time frame: throughout duration of the study (+ 30 days for spontaneously reported SAEs)

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer and Personal Products Worldwide

Industry

Registry information

Official study title

A Single-blind, Multi-center, In-home Use Study to Evaluate Sexual Enhancement Effects of Product PD-F-5394 in Females

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 24, 2008
Registry last updated
Oct 6, 2011

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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