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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
183
Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
proDERM GmbH
Hamburg, Pinneberg, Germany
Female Sexual Function Index (FSFI) score compared to baseline
The Change in FSFI from the baseline event and at 4-weeks post baseline
Time frame: 4 weeks after baseline
Change from baseline in the Female Sexual Function Index (FSFI) individual domain scores
Change from baseline in the FSFI individual domain scores (desire, arousal, lubrication, orgasm, satisfaction, and pain) at 4-weeks post baseline
Time frame: 4 weeks after baseline
Overall proportion of subjects with Adverse Events/Adverse Device Effects (AE/ADEs)
Overall proportion of subjects with Adverse Events/Adverse Device Effects (AE/ADEs) i.e. the occurrence of one of more AE/ADE per subject.
Time frame: 4 weeks
Subject perception of the personal lubricants through Subject Percieved Questions
Subjects' perception of each of the five personal lubricants will be determined through Subject Perceived Questions
Time frame: Initial application (within 24 hours of intercourse) and after 4 weeks
Global evaluation of the personal lubricants (subjective opinion)
• Subjects global evaluation of the five personal lubricants will be determined through global evaluation of effectiveness, tolerability and usability
Time frame: 4 weeks after baseline
Vaginal Epithelial Tolerability (VET)
An assessment of the Vaginal Epithelial Tolerability (VET) of the five personal lubricants as assessed by gynaecologist examination.
Time frame: Baseline, 2 and 24 hours post single application
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
Tolerability as assessed by Subject Perceived Questions
Tolerability of the five personal lubricants will be determined through Subject Perceived Questions
Time frame: 24 hours post single application.
Global Assessment of Tolerance for each subject by a Gynaecologist
Determined by professional assessment of each individual.
Time frame: 24 hours post single application
Overall Tolerance Rating Statement for each lubricant by a Gynaecologist
An overall summary statement of tolerance of each lubricant will be made by the Gynaecologist, taking into consideration all tolerance assessments across all subjects and the nature of the IP in its intended use
Time frame: 24 hours post single application