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

NCT01334827 | Completed Results

• 2 other identifiers: 11800R33AI076967
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbicide Delivery System Acceptability

Keywords

topical microbicide; primary prevention; HIV; drug 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 gel; Other: low volume gel; Other: vaginal film

Interventions

high volume gel OTHER

4 mL HEC

Also known as: Gray

Formulations

low volume gel OTHER

2 mL HEC

Also known as: Red

Formulations

vaginal film OTHER

1" x 2" intravaginal quick-dissolving film

Also known as: Blue

Formulations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• ImQuest Pharmaceuticals, Inc.: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Interventions

Radiation Dosage; Dyrk Kinases; RID

Intervention Hierarchy (Ancestors)

Radiometry; Investigative Techniques; Radiation; Physical Phenomena; Radiologic Health; Public Health; Environment and Public Health; Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Protein-Tyrosine Kinases; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

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

kate.guthrie@lifespan.org

401-793-8180

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

Study Design

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

Model Details: Mixed Methods Measurement Development study

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 13, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 15, 2025
• Results First Posted: December 8, 2020

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)