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

NCT06821152 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2025-11-24

No results posted yet for this study

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

Interventions

DEVICE

Miss Liberty Condom

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.

DEVICE

FC2 condom

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.

Sponsors & Collaborators

  • University of Witwatersrand, South Africa

    lead OTHER

Principal Investigators

  • Mags Beksinska, PhD · University of Witwatersrand, South Africa

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-21
Primary Completion
2025-10-15
Completion
2025-10-15

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06821152 on ClinicalTrials.gov