Coitus Clinical Trial - A Safety Evaluation of Personal Lubricant Product

Clinical Trial Description

Study to evaluate the safety of Class II personal lubricant devices. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Coitus

See also
Status	Clinical Trial	Phase
Unknown status	`NCT02306655` - Coital Incontinence: Incidence and Quality of Life Impact.	N/A
Recruiting	`NCT06134609` - Does Sexual Intercourse Affect the Outcomes of Frozen-thawed Embryo Transfer?	N/A
Completed	`NCT00778934` - In-Home Use Study to Evaluate Use of an Intimate Health Product in Females	N/A

See also

Status

Clinical Trial

Phase

Unknown status

NCT02306655 - Coital Incontinence: Incidence and Quality of Life Impact.

N/A

Recruiting

NCT06134609 - Does Sexual Intercourse Affect the Outcomes of Frozen-thawed Embryo Transfer?

N/A

Completed

NCT00778934 - In-Home Use Study to Evaluate Use of an Intimate Health Product in Females

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT00779025
Study type	Interventional
Source	Johnson & Johnson Consumer and Personal Products Worldwide
Contact
Status	Completed
Phase	N/A
Start date	January 2008
Completion date	February 2008

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms