Safety Study for an All-in-One Body and Personal Lubricant

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a one-week study designed to test the safety of an all-in-one body and personal lubricant product during in-home use.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety Study of a Sensitive Sensual Touch and Personal Lubricant

NCT01271036

Inadequate Lubrication

COMPLETED NA

A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions

NCT00779025

Coitus

COMPLETED NA

A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female Subjects

NCT02737592

Erythema Edema

COMPLETED NA

Clinical Study to Prove Safety in Use (Irritability and Sensitization in Genital Mucosa) of an Intimate Lubricating Gel

NCT02441647

Female Dry Genital Mucosa

COMPLETED NA

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

NCT00778934

Coitus

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a single-center, medically supervised, single-arm study to evaluate the safety of an all over body and personal lubricant product in home-use conditions via clinical assessment. The study will consist of 2 visits. Subjects who meet the entrance criteria will receive investigational product (IP) and 2 subjective questionnaires for at-home completion. The subjects will be required to use the IP at least 2 times, as instructed over the 1-week home-use period. At the end of the study (visit 2) subjects will return to the study site, at which time the unused IP and questionnaires will be returned and a final clinical assessment will be performed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lubricating Agents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Formula PD-F-7619

At least twice per week for one week, massage about a dime-sized amount of the PD-F-7619 personal lubricant product to the application site as directed.

Group Type EXPERIMENTAL

Formula PD-F-7619

Intervention Type DEVICE

Off-White to Beige Lotion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Formula PD-F-7619

Off-White to Beige Lotion

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

All-In-One Caressing Crème & Personal Lubricant K-Y Touch Massage Warming 2-in-1 Personal Lubricant

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Normal, healthy adults in a stable, monogamous, ongoing heterosexual relationship with current partner within protocol-specified parameters
* Subjects comfortable discussing sensitive topics such as personal hygiene, menstruation and sexuality
* Able to read and understand English
* Voluntarily signs an Informed Consent document after the trial has been explained
* Willing to follow all study procedures, including birth control requirements

Exclusion Criteria

* Any medical or mental health history or condition, or use of any product, drug or medication that per protocol (or in the opinion of the Investigator) might compromise the participant's safety or the analysis of results
* Participation as a research subject in a different trial within timelines dictated by protocol
* Participants with relationships or employment outside protocol-defined parameters

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes