Description

In-Use Test Under Gynecological Control

Supervised In-Use Test under Gynecological Control

This study is a 21-day supervised in-use test with 20 volunteers, conducted under the oversight of a qualified gynecologist. The study includes clinical evaluation and final gynecologist sign-off, providing medically supervised data on product tolerance and performance in the intimate area.

Because products intended for intimate use require a higher level of safety assessment, this study is designed to evaluate real-world use conditions while maintaining clinical control.

Study Purpose

This study evaluates how a product performs when used on the intimate area over time. It focuses on:

• Tolerance
• User comfort
• Cosmetic acceptability

It also helps determine whether repeated use may lead to irritation or discomfort.

Study Design

The study follows a controlled, supervised in-use design over 21 days at a clinical site.

• 20 adult female volunteers participate
• Participants use the product as directed under normal conditions
• A gynecologist oversees the study and performs clinical evaluation
• A final medical review and sign-off is provided

This structure ensures results reflect real product use while maintaining medical oversight.

Study Population

Participants are adult female volunteers selected based on the intended product use.

All participants:

• Are in good general health
• Have no active gynecological conditions at study start

This ensures that observed effects are attributable to the product.

Evaluation Criteria

Clinical and subjective evaluations are performed throughout the study.

Clinical assessments may include:

• Redness
• Swelling
• Dryness
• Burning or itching
• Signs of irritation

Participants also complete structured questionnaires to document:

• Comfort
• Sensory experience
• Overall acceptability

Both clinical observations and user feedback are included in the final evaluation.

Claims Supported

This study can support a range of marketing and safety claims, including:

• Gynecologist tested
• Gynecologically tested
• Clinically tested
• Tested under gynecological control
• Suitable for intimate use
• Dermatologically and gynecologically tested (when combined with other studies)
• Gentle on intimate areas (subject to results)

Final claim support depends on study outcomes and regulatory context.

Data Review and Reporting

At the conclusion of the study:

• Data is summarized using descriptive analysis
• A clear and structured report is issued
• A final evaluation and sign-off by the gynecologist is included

The report is suitable for use in safety documentation, product dossiers, and marketing support.

Why Choose Pentyl Labs

Pentyl Labs coordinates supervised in-use testing with:

• Clear study protocols
• Reliable timelines
• Easy-to-interpret reports
• Integration with broader testing programs

We also support related services such as HRIPT, safety assessments, and claims substantiation, allowing results to fit seamlessly into your product development and compliance strategy.

Get Started

Contact [email protected] to request a Supervised In-Use Test under Gynecological Control.