NCT05644444

Effectiveness and Safety of a Water-based and a Silicone-based Personal Lubricants With Sensory Action

A Two-arm, Parallel-design, Clinical Investigation to Determine the Effectiveness and Safety of a Water-based Personal Lubricant With a Sensory Action and Silicone-based Personal Lubricant With a Sensory Action for the Relief of Intimate Discomfort Associated With Vaginal Dryness

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Reckitt Benckiser Healthcare (UK) Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This clinical investigation will look at the effectiveness and safety of two personal lubricants for the relief of intimate discomfort associated with vaginal dryness.

Detailed description

This is an open label, two-arm, parallel-design clinical investigation determining the effectiveness and safety of two personal lubricants. This clinical investigation consists of two phases, a Tolerance Phase and a Treatment Phase, whereby a sub-set of subjects will enter the Tolerance Phase followed by the Treatment Phase. The remaining subjects will enter the Treatment Phase only.

Conditions

• Dyspareunia
• Vaginal Dryness

Interventions

Type	Name	Description
DEVICE	Lubricant A (sensate water-based personal lubricant) and Comparator A (non-sensate water-based lubricant)	In the tolerance phase, a pea-sized lubricant will be considered a single application for oral assessment and approximately 3g of lubricant will be considered a single application for vaginal assessment. In the treatment phase, approximately 3g of lubricant will be considered a single application.
DEVICE	Lubricant B (sensate silicone-based personal lubricant) and Comparator B (non-sensate silicone-based personal lubricant)	In the tolerance phase, a pea-sized lubricant will be considered a single application for oral assessment and approximately 3g of lubricant will be considered a single application for vaginal assessment. In the treatment phase, approximately 3g of lubricant will be considered a single application.

Timeline

• Start date: 2023-02-20
• Primary completion: 2023-05-05
• Completion: 2023-05-05
• First posted: 2022-12-09
• Last updated: 2025-02-11
• Results posted: 2025-02-11

Locations

1 site across 1 country: Germany