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

NCT ID: NCT01334827

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-06-30

Brief Summary

The purpose of the study is to compare, contrast, and characterize the range of user perceptions and potential acceptability of three (3) topical vaginal microbicide dosage forms.

Detailed Description

The success of microbicide products will derive from the synergy of their biological functionality and user acceptability. Biological functionality is the integrated result of safe and effective anti-HIV compounds incorporated into dosage forms or devices that successfully deliver those compounds to target tissues, fluids, and pathogens. Acceptability is a multi-factorial phenomenon that accounts for the personal, dyadic, product-related, and social contexts that potentiate - or not - a woman's decision to use a microbicide. Acceptability (assessed, in part, by the users' sensory perceptions of products during use) depends strongly upon dosage forms and/or delivery systems with biophysical functions and/or mechanical and materials properties that are most conducive to human use. Without both, microbicides' potential to decisively alter the public health impact of HIV/AIDS and other sexually transmitted infections will be largely limited. The current protocol will specifically study the impact of gel volume on user perceptions, as well as extend user perception scale development to include those properties and product "behaviors" experienced when using a vaginal film.

Conditions

Microbicide Delivery System Acceptability

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Formulations

high volume gel; low volume gel; vaginal film

Group Type: OTHER

high volume gel

Intervention Type: OTHER

4 mL HEC

low volume gel

Intervention Type: OTHER

2 mL HEC

vaginal film

Intervention Type: OTHER

1" x 2" intravaginal quick-dissolving film

Interventions

high volume gel

4 mL HEC

Intervention Type: OTHER

low volume gel

2 mL HEC

Intervention Type: OTHER

vaginal film

1" x 2" intravaginal quick-dissolving film

Intervention Type: OTHER

Other Intervention Names

Gray; Red; Blue

Eligibility Criteria

Inclusion Criteria

Women who:

• are between the ages of 18 and 45
• report vaginal sex with their male sexual partner in the past 6 months
• report being in a monogamous sexual relationship with their male partner
• report consistent use of an effective birth control method: e.g., hormonal contraceptive, IUD, bilateral tubal ligation, Essure® or any non-incisional permanent birth control procedure, hysterectomy (partial or total, with/without oophorectomy), partner's vasectomy/salpingectomy
• are able to tolerate film use, as measured by pelvic exam at Visit 1B
• are willing to refrain from any vaginal product use (inclusive of douching) for 48 hours before Visit 1B and until they complete all study activities (except for study-related products)
• are willing to refrain from having vaginal intercourse 24 hours before Visit 1B and Visits 2-4
• are willing to use condoms for vaginal-penile sex between all study visits (Visits 1A - 4)
• are willing to refrain from any non-penile vaginal penetration during dosage form evaluation visits (Visits 2-4)
• are willing to undergo HIV testing and receive test results and counseling.

Men who:

• are at least 18 years of age
• report vaginal sex with their female sexual partner in the past 6 months
• report being in a monogamous sexual relationship with their female sexual partner
• are willing to refrain from having vaginal intercourse 24 hours before Visit 1B and Visits 2-4
• are willing to use condoms for vaginal-penile sex between all of study visits (Visits 1A-4)
• are willing to refrain from any non-penile vaginal penetration during dosage form evaluation visits (Visits 2-4)
• are willing to use a non-lubricated latex condom (provided) for penile-vaginal intercourse during dosage form evaluation visits (Visits 2-4)
• are willing to undergo HIV testing and receive test results and counseling.

Exclusion Criteria

Women and men will be ineligible if:

• they are unable or unwilling to give informed consent
• their partner is unable or unwilling to give informed consent
• they are currently enrolled in other vaginal product study/studies
• they are STI (Neisseria gonorrhea, Chlamydia trachomatis, bacterial vaginosis, trichomoniasis, syphilis), HIV positive upon screening (Visit 1A), or pregnant (females) at any study visit
• they are breastfeeding, or have completed menopause (i.e., at least 12 months without menstrual periods) (female participants only)
• they are currently attempting to get pregnant or have an intention to get pregnant during their participation in the study
• they have clinically significant abnormal pelvic findings and/or findings requiring therapy as a function of clinical exam at Visits 1A and/or 1B (female participants only)
• they report being within 30 days of their last pregnancy outcome or gynecologic surgical procedure
• they have known, or suspected, allergies to any component of the study products or similar ingredients in other products
• they have known, or suspected, allergies to latex
• they have any condition that, in the opinion of the study clinician or principle investigator, would compromise the participant´s ability to participate in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ImQuest Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Buckheit, PhD

Role: PRINCIPAL_INVESTIGATOR

ImQuest Pharmaceuticals

Kathleen Morrow, PhD

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Locations

Miriam Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

R33AI076967

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11800

Identifier Type: -

Identifier Source: org_study_id