NCT00778934

Brief Summary

The purpose of this study is to evaluate the effects of an intimate health product on sexual experience in females.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
Last Updated

October 6, 2011

Status Verified

October 1, 2011

Enrollment Period

2 months

First QC Date

October 23, 2008

Last Update Submit

October 4, 2011

Conditions

Coitus

Outcome Measures

Primary Outcomes (1)

  • To assess the effect of product on sexual enhancement by comparing baseline questionnaire responses to the end of study questionnaire responses

    End of study (3 weeks after baseline visit)

Secondary Outcomes (1)

  • Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.

    throughout duration of the study (+ 30 days for spontaneously reported SAEs)

Study Arms (1)

1

EXPERIMENTAL

Intimate Health Gel

Other: Intimate Health Gel

Interventions

Intimate Health GelOTHER

Intimate Health Gel

Also known as: Not marketed yet
1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal, healthy females \>18 years of age
  • In committed heterosexual relationship for \>6months
  • Of adequate sexual functioning
  • On acceptable method of birth control

You may not qualify if:

  • Pregnant or breastfeeding
  • Allergy to product ingredients
  • Irritation or infection in genital area
  • Unstable or uncontrolled medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center of Marital and Sexual Health of South Florida

West Palm Beach, Florida, 33401, United States

Location

Center for Marital and Sexual Health, Inc.

Beachwood, Ohio, 44122, United States

Location

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Rita Wanser

    J&J CPPW

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2008

First Posted

October 24, 2008

Study Start

December 1, 2007

Primary Completion

February 1, 2008

Study Completion

April 1, 2008

Last Updated

October 6, 2011

Record last verified: 2011-10

Locations

US(2)