Functional Performance and Acceptability Evaluation of the Miss Liberty Female Condom Compared to the FC2 Female Condom

NCT06821152 | Completed

• 1 other identifier: Miss Liberty
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the functional performance and acceptability of the Miss Liberty female condom version 1 (Miss Liberty female condom), compared to the FC2 female condom. The study will be a sequential randomised 2-period cross-over trial comparing five uses of the Miss Liberty female condom, compared to the control FC2 female condom. Each woman will be asked to use five Miss Liberty female condoms, and five FC2 control female condoms in a randomised order. Woman will complete a Condom Use Report after each condom use. Function, safety, and acceptability will be assessed at each of two follow-up visits conducted after using each set of five condoms. The trial will enrol 235 women between 18-45 years old. The primary objective is to ascertain the functional performance of the Miss Liberty female condom compared to the control FC2 female condom. The secondary objectives are to determine the acceptability and safety (as determined by the number of adverse events) for the Miss Liberty female condom compared to the FC2 female condom.

Conditions

Functional Performance

Keywords

Female condom; condom acceptability; Miss Liberty; FC2; condom safety

Outcome Measures

Primary Outcomes (5)

• Clinical breakage

  Defined as breakage or tearing of the female condom during sexual intercourse or during withdrawal from the vagina. Clinical breakage is breakage with potential adverse clinical consequences. The clinical breakage rate is calculated by dividing the number of female condoms reported to have broken or torn during sexual intercourse or during withdrawal by the number of female condoms used during sexual intercourse.

  2-3 months

• Clinical slippage

  Defined as an instance when a female condom slips completely out of the vagina during sexual intercourse. The clinical slippage rate is calculated by dividing the number of female condoms that slipped by the number of female condoms used during sexual intercourse.

  2-3 months

• Clinical misdirection

  Defined as vaginal penetration whereby the penis is inserted between the female condom and the vaginal wall. The clinical misdirection rate is calculated by dividing the number of reported events of misdirection by the number of female condoms used during sexual intercourse.

  2-3 months

• Clinical invagination

  Defined as an instance when the external retention feature of the female condom is partially or fully pushed into the vagina during sexual intercourse. The clinical invagination rate is calculated by dividing the number of events of invagination by the number of female condoms used during sexual intercourse.

  2-3 months

• Total clinical failure

  Defined as the sum of female condoms with at least one clinical failure event (clinical breakage, clinical slippage, clinical misdirection, clinical invagination) clinically break or additional failure modes(s) identified in the risk assessment which results in the reduction of the female condom protective function. The total clinical failure rate is calculated by dividing the number of female condoms with a clinical failure by the number of female condoms used during sexual intercourse.

  2-3 months

Secondary Outcomes (5)

• Condom Safety

  2-3 months

• Acceptability

  2-3 months

• Non-Clinical breakage

  2-3 months

• Total breakage

  2-3 months

• Non-Clinical slippage

  2-3 months

Study Arms (2)

Arm 1 - Type A - Type B

ACTIVE COMPARATOR

A separate randomization process (implemented by an independent statistician) will allocate one of the two study condom types to the letters A and B which will be used to label individual packs of five condoms for distribution to study women and to record the condom type used in each study period.

Device: Miss Liberty Condom; Device: FC2 condom

Arm 2 -Type B - Type A

ACTIVE COMPARATOR

A separate randomization process (implemented by an independent statistician) will allocate one of the two study condom types to the letters A and B which will be used to label individual packs of five condoms for distribution to study women and to record the condom type used in each study period.

Device: Miss Liberty Condom; Device: FC2 condom

Interventions

Miss Liberty Condom DEVICE

The Miss Liberty female condom is manufactured by Zhejiang Rui Bo 001 High Polymer Co, Ltd. The condom is designed as a loose-fitting pouch that lines the vagina. It has two flexible rings. The sheath, are made of polyurethane. The outer ring remains outside the vagina and covers the external genitalia during intercourse. An internal ring is removable and serves as the insertion mechanism and anchors the device within the vagina. Miss Liberty measures 180mm in length and 78mm in lay-flat width. The device is pre-lubricated with silicone oil. This condom is a similar design (material, length, width) to the USFDA approved FC1 female condom which was discontinued and replaced by FC2.

Arm 1 - Type A - Type B; Arm 2 -Type B - Type A

FC2 condom DEVICE

The FC2 is a second-generation female condom manufactured by the Female Health Company (Chicago, IL). The FC2 has US FDA approval and has been granted the CE Mark of the European Union. The FC2 is pre-qualified by the WHO. The condom is designed as a loose-fitting pouch that lines the vagina. It has two flexible rings. The outer ring at the open end is rolled from the nitrile material. The outer ring remains outside the vagina and covers the external genitalia during intercourse. An internal ring is removable and serves as the insertion mechanism and anchors the device within the vagina. FC2 measures 170mm in length and 80mm in lay-flat width. The device is pre-lubricated with silicone oil. This FC is available in the public health sector in South Africa.

Arm 1 - Type A - Type B; Arm 2 -Type B - Type A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Participants must be female as female condoms inserted vaginally are being evaluated
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Witwatersrand, South Africa: lead

Study Sites (1)

MatCH Research Unit [Maternal, Adolescent and Child Health Research Unit]

Durban, KwaZulu-Natal, 4001, South Africa

Location

Related Publications (9)

• Holm S. A simple sequentially rejective multiple test procedure. Scand J Statist 6: 65-70, 1979).

  BACKGROUND

• Taylor D. Issues in the design, analysis and interpretation of condom functionality studies. Contraception. 2009 Sep;80(3):237-44. doi: 10.1016/j.contraception.2009.03.004. Epub 2009 Apr 23.

  PMID: 19698815 BACKGROUND

• Beksinska M, Wong R, Smit J. Male and female condoms: Their key role in pregnancy and STI/HIV prevention. Best Pract Res Clin Obstet Gynaecol. 2020 Jul;66:55-67. doi: 10.1016/j.bpobgyn.2019.12.001. Epub 2019 Dec 14.

  PMID: 32007451 BACKGROUND

• Center for Health and Gender Equity. Female condoms and US foreign assistance: an unfinished imperative for women's health. Washington, DC; 2011

  BACKGROUND

• United Nations Population Fund. HIV prevention gains momentum. New York: UNFPA, 2011. 978-0-89714-933-4

  BACKGROUND

• Shisana O, Rehle T, Simbayi LC, et al. South African national HIV prevalence, incidence, behaviour and communication survey 2017: Health and wellbeing: Human Science Research Council Press; 2017

  BACKGROUND

• Martinez G, Copen CE, Abma JC. Teenagers in the United States: sexual activity, contraceptive use, and childbearing, 2006-2010 national survey of family growth. Vital Health Stat 23. 2011 Oct;(31):1-35.

  PMID: 22256688 BACKGROUND

• Warren M. Condoms: the multipurpose prevention technologies that already exist. BJOG. 2014 Oct;121(Suppl 5):9-11. doi: 10.1111/1471-0528.12913. No abstract available.

  PMID: 25335833 BACKGROUND

• World Health Organization Department of Sexual and Reproductive Health and Research (WHO/SRH) and Johns Hopkins Bloomberg School of Public Health/ Center for Communication Programs (CCP), Knowledge SUCCESS. Family Planning: A Global Handbook for Providers (2022 update). Baltimore and Geneva: CCP and WHO; 2022. chromeextension://efaidnbmnnnibpcajpcglclefindmkaj/https://fphandbook.org/sites/default/files/WH O-JHU-FPHandbook-2022Ed-v221114b.pdf

  BACKGROUND

Related Links

• UNFPA, Universal access to Reproductive Health: Progress and Challenges.
• Muchiri E, Odimegwu E, DeWet N. HIV risk perception and consistency in condom use among adolescents and young adults in urban Cape Town, South Africa: a cumulative risk analysis. S Afr J Infect Dis \[Internet\]. 2017 \[cited 2019 Sep 8\]; 32(3):105-110.
• eproductive Health Supplies Coalition. Caucus on new and underused reproductive health technologies. Product brief: female condom. Reproductive Health Supplies Coalition; 2013. \[Online\]. \[Cited: 19th Dec 2016\].
• UNFPA Prequalified Female Condom Manufacturers List
• ISO 29943-2:2017 Condoms - Guidance on clinical studies - Part 2: Female condoms, clinical function studies based on self-diaries.
• ISO 25841:2017 Female condoms Requirements and test methods.

Study Officials

• Mags Beksinska, PhD

  University of Witwatersrand, South Africa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician preparing the randomization sequences and analyzing the data will remain masked while developing and testing the analysis programs and procedures and drafting the preliminary study report.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director

Model Details: This research study will be a two-period, cross-over randomized controlled trial to compare the functional performance, safety and acceptability of two female condom types.

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: May 21, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)