NCT04908124

A Clinical Investigation Into the Effectiveness and Safety of Five Water Based Personal Lubricants.

An Open Label, Parallel-design, Clinical Investigation to Determine the Effectiveness and Safety of Five Water Based Personal Lubricants for the Relief of Intimate Discomfort Associated With Vaginal Dryness.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Reckitt Benckiser Healthcare (UK) Limited · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This clinical investigation will look at the safety of five water based personal lubricants, and teir effectiveness the relief of intimate discomfort associated with vaginal dryness.

Detailed description

This is an open label, five-arm, parallel-design clinical investigation determining the effectiveness and safety of five personal lubricants. This clinical investigation consists of two phases, a Tolerance Phase and a Treatment Phase, whereby a sub-set of subjects will enter both 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	Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
DEVICE	Lubricant B	Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
DEVICE	Lubricant C	Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
DEVICE	Lubricant D	Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
DEVICE	Lubricant E	Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-06-29
• Completion: 2021-06-29
• First posted: 2021-06-01
• Last updated: 2021-07-02

Locations

1 site across 1 country: Germany