Trials Sponsors Conditions Drugs Pricing

Conditions

Microbicide Delivery System Acceptability

Keywords

topical microbicideprimary preventionHIVdrug delivery systems

Outcome Measures

Primary Outcomes (1)

User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
USPE Sum of averaged item means/# items (min:max 1:5); 1=Do not agree at all;2=Agree a little;3=Agree somewhat;4=Agree a lot;5=Agree completely. Products:Low volume gel, high volume gel, film.Initial Penetration:Smoothness/lubricity; Initial Lubrication:Coating/lubricating; Spreading Behavior:Ease of stroke, product spread; Product Awareness:Feel intravaginally during sex (movement, felt betw vaginal wall-penis); Perceived Wetness:Covering entire vagina; as after orgasm; Stimulating: enhanced pleasure; Messiness:Perceptions of watery/messiness; Leakage:Sensations of leaking during/after sex; in pubic hair; need to clean; Pre-coital Leakage:Product felt/leakage noticed on panty liner before sex; Naturalness:Sensation of naturalness; leakage looked like vaginal fluid; Lubricity:Wetness before sex; slipperiness/lubricity during sex; Effortful:Effort needed at penetration; effort difficulty/dryness; Pleasure:Partner's stimulation; Noticeable:Male sensation during sex, messiness, thickness
4-5 visits over an average of 8-12 weeks

Study Arms (1)

Formulations

OTHER

high volume gel; low volume gel; vaginal film

Other: high volume gelOther: low volume gelOther: vaginal film

Interventions

high volume gelOther

4 mL HEC

Also known as: Gray

Formulations

low volume gelOther

2 mL HEC

Also known as: Red

Formulations

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Women who:
are between the ages of 18 and 45

Sponsors & Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
NIHcollaborator
ImQuest Pharmaceuticals, Inc.
Industrycollaborator

Study Sites (1)

Miriam Hospital

Providence, Rhode Island, 02906, United States

MeSH Terms

Interventions

Radiation DosageDyrk KinasesRID

Intervention Hierarchy (Ancestors)

RadiometryInvestigative TechniquesRadiationPhysical PhenomenaRadiologic HealthPublic HealthEnvironment and Public HealthProtein Serine-Threonine KinasesProtein KinasesPhosphotransferases (Alcohol Group Acceptor)PhosphotransferasesTransferases

Limitations and Caveats

User Sensory Perceptions \& Experience (USPE) scales adapted and were used for the first time with male sexual partners in Project MIST.

Results Point of Contact

Title: Dr Kate Guthrie, Co-Investigator, Project MIST Lead Investigator
Organization: The Miriam Hospital

Study Officials

Robert Buckheit, PhD
ImQuest Pharmaceuticals
PRINCIPAL INVESTIGATOR
Kathleen Morrow, PhD
The Miriam Hospital
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

48 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 11, 2011

First Posted

April 13, 2011

Study Start

April 2011

Actual (reported)

A Formative Study to Explore the Sensory Perceptions of Vaginal Product Users

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Formulations

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Formulations

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations