New female condom tested against market leader
NCT ID NCT06821152
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tested a new female condom called Miss Liberty against the existing FC2 female condom. 235 women aged 18-45 used each condom five times in a random order. Researchers measured breakage, slippage, and other failures to see if Miss Liberty works as well as FC2. They also checked safety and how much women liked using it.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Miss Liberty female condom (polyurethane device with two flexible rings)
- What this could lead to
- If successful, this could provide a safe and acceptable alternative female condom option for pregnancy and STI prevention.
- What could go wrong
- This is a completed device comparison study, not a treatment trial. Results may show no significant difference or lower performance than FC2.
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
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235 people
The number who actually took part.
- Started
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May 2025
- Finished
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Oct 2025
- Lead sponsor
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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
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Be between the ages of 18 and 45 years (inclusive); * Be of female sex and gender * Be literate (able to read a newspaper or letter easily); * Have been in an exclusive (monogamous) heterosexual sexual relationship with a male partner partner for at least 3 months; and intend to continue to be an exclusive (monogamous) sexual relationship with their spouse or partner while participating in this research study; * Be sexually active (defined as having at least one vaginal coital act per week); * Willing to give informed consent; * Willing to complete the female condom coital use reports; * Willing to use the study condoms as directed; * Agree to only use the study condoms sequentially during time of participation * Willing to adhere to the follow-up schedule and all study procedures; * Willing to provide research study staff with an address, phone number or other locator information while participating in the study; * Willing to participate in the study for the duration of 10 condom uses (approximately 2- 3 months); * Willing to have a fingerprint scan to exclude co-enrolment in other research projects; * Using hormonal or other non-barrier contraception (e.g. Oral Contraceptives, injectables, implant, Intrauterine device (IUD), or have had a tubal sterilization) or male partner vasectomised; * Agree to return any unopened condoms; * Agree to not bring study condoms in contact with genital or oral piercing jewelry; * Able to understand instructions for correct use of female condoms; * Agree not to use male condoms when using the female condom in a single sex act. Exclusion Criteria: * Woman is pregnant or desires to become pregnant during the time of the research study; * Known to be HIV positive by self report; * Self-reported history of current sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia); * Female (or reports her partner) has genital piercing jewelry, uses genital beading or uses sex toys, drugs, medications or non-study devices that can affect sexual performance; * Female (or reports her partner) has known sensitivities or allergies to latex, synthetic nitrile, vaginal/sexual lubricants or lubricants used on condoms; * Female has symptoms of a sexually transmitted infection (STI). * Male partner has known erectile or ejaculatory dysfunction; * Is a past or current employee of the University of the Witwatersrand or Miss Liberty Ltd;
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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
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MatCH Research Unit [Maternal, Adolescent and Child Health Research Unit]
Durban, KwaZulu-Natal, 4001, South Africa
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