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What do women think? study explores feel of vaginal products

NCT ID NCT01334827

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how 48 women felt about three different vaginal products: a low-volume gel, a high-volume gel, and a quick-dissolving film. The goal was to understand what women like and dislike about each product, which could help make future HIV prevention gels and films more acceptable. Participants used each product during sex and rated their sensory experiences.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help design more acceptable vaginal microbicides, potentially improving HIV prevention options for women.
What could go wrong
This is a small, early-stage study focused on user perceptions, not on testing effectiveness against any disease. Results may not translate to real-world use or product success.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

48 people

The number who actually took part.

Started

Apr 2011

Finished

Jun 2012

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Miriam Hospital

    Providence, Rhode Island, 02906, United States