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

Completed · Not applicable

Conditions studied: Microbicide Delivery System Acceptability

In brief

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.

Key facts

Study ID

NCT01334827

Run by

The Miriam Hospital

People needed

48

Starts

2011-04-01

Expected to finish

2012-06-01

Last updated by the study team

2025-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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
• 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.

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

Where it is running

• Miriam Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.