A Functional Performance Study of The Wondaleaf Female Condom

NCT04076774 | Completed FDA Device

• 2 other identifiers: MD201805025020
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

This research study will determine how well two female condoms perform when used during sex. One of these condoms (FC2) is already commercially available in South Africa. The other female condom, "Wondaleaf Condom" is a new female condom. Participants will use both condoms. The study aims to determine how well these condoms work comparatively. Study visits include a screening/enrolment visit and 2 follow up visits.

Conditions

HIV Prevention; Pregnancy Prevention

Keywords

female condom; HIV and STI prevention; Condom acceptability; Wondaleaf; FC2

Outcome Measures

Primary Outcomes (7)

• Clinical breakage

  Clinical breakage is defined as breakage during sexual intercourse or during withdrawal of the female condom 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 during sexual intercourse or during withdrawal by the number of female condoms used during sexual intercourse.

  Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks)

• Total breakage

  Total breakage is defined as the sum of all female condom breakages at any time before, during or after sexual intercourse. It includes both clinical breakages and non-clinical breakages. The total breakage rate is calculated by dividing the total number of female condoms that broke by the number of female condom packages opened

  Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks)

• Slippage

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

  Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks)

• Misdirection

  Invagination is 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 invagination rate is calculated by dividing the number of events of invagination by the number of female condoms used during sexual intercourse.

  Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks)

• Invagination

  Invagination is 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 invagination rate is calculated by dividing the number of events of invagination by the number of female condoms used during sexual intercourse.

  Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks)

• Total clinical failure

  Total clinical failure is defined as the sum of female condoms that clinically break or slip, or are associated with misdirection, invagination or any 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.

  Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks)

• Total female condom failure

  Total female condom failure is defined as a female condom for which a non-clinical breakage, clinical breakage or slippage occurs, or is associated with misdirection, invagination or any additional failure modes(s) identified in the risk assessment. The female condom failure rate is calculated by dividing the number of female condoms that fail by the number of female condom packages opened.

  Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks)

Secondary Outcomes (2)

• Safety (Adverse Events)

  Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks)

• Acceptability

  Number of condoms allocated in each arm is 5. Duration of time these condoms will be used depends on the coital frequency of the couple. Therefore the duration of time in each arm is dependent on time take to use all 5 condoms. (approximately 3-6 weeks)

Study Arms (2)

Wondaleaf female condom

EXPERIMENTAL

Participants will be provided with 5 Wondaleaf condoms first at enrolment and switched to 5 FC2 condoms at the first follow up visit

Device: Wondaleaf Female Condom; Device: FC2 Female Condom

FC2 Female condom

ACTIVE COMPARATOR

Participants will be provided with 5 FC2 condoms first at enrolment and switched to 5 Wondaleaf condoms at the first follow up visit

Device: Wondaleaf Female Condom; Device: FC2 Female Condom

Interventions

Wondaleaf Female Condom DEVICE

Wondaleaf: Wondaleaf is an ultra thin (of 0.02 mm) polyurethane female/male condom (16x8cm) that has folded extended adhesive shields (front 18x18cm, back 18x10cm), which at unfolding covers the entire external genitalia to prevent direct skin contact and exchange of body fluid between sexual partners during intercourse. Insertion of the condom body into the vagina is through use of a small medical grade cotton tissue packed inside the foil package. This is inserted into the end of the condom body and used to push the condom into the vagina. Each condom is individually packaged without prior lubrication. However, lubricant is expected to be used at donning the condom and during sexual intercourse. The lubricant will be supplied in separate packets together with the condom. Unlike latex, polyurethane condoms are unlikely to cause any allergic reaction and are much stronger than conventional latex condoms

FC2 Female condom; Wondaleaf female condom

FC2 Female Condom DEVICE

FC2: 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 (Conformité Européenne) of the European Union. The FC2 is the only female condom that has been pre-qualified by the World Health Organisation. The device is similar in design to the FC1, but is made from a synthetic polymer (nitrile) film that is softer and more elastic than the polyurethane of the earlier device. 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 polyurethane ring is removable and serves as the insertion mechanism and anchors the device within the vagina. FC2 measures 180mm in length and 80mm in lay-flat width. The device is pre-lubricated with dimethicone.

FC2 Female condom; Wondaleaf female condom

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 literate (able to read a newspaper or letter easily);
• Be sexually active (defined as having at least two vaginal coital acts per week and not being abstinent in the month prior to enrolment);
• Be in an exclusive (monogamous) sexual relationship with her spouse or partner while participating in this research study;
• Have been in a sexual relationship with this partner for at least 6 months;
• Not be a sex worker;
• Not be pregnant (as determined by pregnancy testing) or planning a pregnancy during the time of the research study;
• Be without observable evidence of Sexually Transmitted Infections (STI) as determined through syndromic diagnosis and vaginal examination;
• Be using hormonal or other non-barrier contraception (e.g. Oral Contraception (OCs), injectable, implant, Intra Uterine Device (IUD), or have had a tubal sterilization);
• Not be menopausal (defined as 12 months without menstruation);
• Not have had a hysterectomy;
• Not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms;
• Willing to give informed consent;
• Willing to complete the FC coital use logs;
• Willing to use the study condoms as directed;

You may not qualify if:

• None specified

Sponsors & Collaborators

• Prof Mags Beksinska: lead

Study Sites (1)

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

Durban, KwaZulu-Natal, 4001, South Africa

Location

Related Publications (18)

• Trussell J, Sturgen K, Strickler J, Dominik R. Comparative contraceptive efficacy of the female condom and other barrier methods. Fam Plann Perspect. 1994 Mar-Apr;26(2):66-72.

  PMID: 8033980 BACKGROUND

• Soper DE, Shoupe D, Shangold GA, Shangold MM, Gutmann J, Mercer L. Prevention of vaginal trichomoniasis by compliant use of the female condom. Sex Transm Dis. 1993 May-Jun;20(3):137-9. doi: 10.1097/00007435-199305000-00003.

  PMID: 8511706 BACKGROUND

• Fontanet AL, Saba J, Chandelying V, Sakondhavat C, Bhiraleus P, Rugpao S, Chongsomchai C, Kiriwat O, Tovanabutra S, Dally L, Lange JM, Rojanapithayakorn W. Protection against sexually transmitted diseases by granting sex workers in Thailand the choice of using the male or female condom: results from a randomized controlled trial. AIDS. 1998 Oct 1;12(14):1851-9. doi: 10.1097/00002030-199814000-00017.

  PMID: 9792386 BACKGROUND

• French PP, Latka M, Gollub EL, Rogers C, Hoover DR, Stein ZA. Use-effectiveness of the female versus male condom in preventing sexually transmitted disease in women. Sex Transm Dis. 2003 May;30(5):433-9. doi: 10.1097/00007435-200305000-00010.

  PMID: 12916135 BACKGROUND

• Hoke TH, Feldblum PJ, Van Damme K, Nasution MD, Grey TW, Wong EL, Ralimamonjy L, Raharimalala L, Rasamindrakotroka A. Temporal trends in sexually transmitted infection prevalence and condom use following introduction of the female condom to Madagascar sex workers. Int J STD AIDS. 2007 Jul;18(7):461-6. doi: 10.1258/095646207781147175.

  PMID: 17623503 BACKGROUND

• PATH and United Nations Population Fund (UNFPA). Female condom: a powerful tool for protection. Seattle: UNFPA, PATH; 2006. Available at: http://www.unfpa.org/upload/lib_pub_file/617_filename_female_condom.pdf.

  BACKGROUND

• World Health Organization (WHO), United States Agency for International Development, Johns Hopkins Bloomberg School of Public Health. Family Planning, A Global Handbook for Providers. Baltimore, MD: Information & Knowledge for Optimal Health (INFO) Project; 2008.

  BACKGROUND

• Beksinska M, Smit J, Joanis C, Usher-Patel M, Potter W. Female condom technology: new products and regulatory issues. Contraception. 2011 Apr;83(4):316-21. doi: 10.1016/j.contraception.2010.07.022. Epub 2010 Sep 15.

  PMID: 21397088 BACKGROUND

• Ting RS, Wong EL, Tnay JK. A pilot study on the functional performance and acceptability of an innovative female condom (Wondaleaf(R)) in Malaysia. Open Access J Contracept. 2018 Jan 24;9:11-20. doi: 10.2147/OAJC.S152505. eCollection 2018.

  PMID: 29440937 BACKGROUND

• Beksinska M, Joanis C, Manning J, Smit J, Callahan M, Deperthes B, Usher-Patel M. Standardized definitions of failure modes for female condoms. Contraception. 2007 Apr;75(4):251-5. doi: 10.1016/j.contraception.2006.10.003. Epub 2007 Feb 7.

  PMID: 17362701 BACKGROUND

• Gallo MF, Grimes DA, Schulz KF. Non-latex versus latex male condoms for contraception. Cochrane Database Syst Rev. 2003;(2):CD003550. doi: 10.1002/14651858.CD003550.

  PMID: 12804475 BACKGROUND

• Williams, E., Experimental Designs Balanced for the Estimation of Residual Effects of Treatments. Australian Journal of Chemistry, 1949. 2(2): p. 149-168.

  BACKGROUND

• STATA User's Guide. College Station, Texas, USA: StataCorp, LP.

  BACKGROUND

• Beksinska ME, Piaggio G, Smit JA, Wu J, Zhang Y, Pienaar J, Greener R, Zhou Y, Joanis C. Performance and safety of the second-generation female condom (FC2) versus the Woman's, the VA worn-of-women, and the Cupid female condoms: a randomised controlled non-inferiority crossover trial. Lancet Glob Health. 2013 Sep;1(3):e146-52. doi: 10.1016/S2214-109X(13)70054-8. Epub 2013 Aug 23.

  PMID: 25104263 BACKGROUND

• Joanis C, Beksinska M, Hart C, Tweedy K, Linda J, Smit J. Three new female condoms: which do South-African women prefer? Contraception. 2011 Mar;83(3):248-54. doi: 10.1016/j.contraception.2010.08.002. Epub 2010 Sep 17.

  PMID: 21310287 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

• ISO 29943-2:2017 Condoms -- Guidance on clinical studies -- Part 2: Female condoms, clinical function studies based on self-reports.

  BACKGROUND

• Beksinska M, Mphili N, Smit J. Functional performance of the Wondaleaf condom: A crossover, noninferiority, randomized clinical trial. Int J STD AIDS. 2023 Feb;34(2):114-121. doi: 10.1177/09564624221139899. Epub 2022 Nov 25.

  PMID: 36426764 DERIVED

Study Officials

• Mags E Beksinska, PhD

  Maternal, Adolescent and Child Health Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The two devices in the trial are distinctly different and so device specific training is required and so cannot be blinded. The statistician analysing the data will be blinded to female condom type.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy 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 FC types (FC2 and Wondaleaf).

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 3, 2019
• Study Start: March 27, 2019
• Primary Completion: October 18, 2019
• Study Completion: October 18, 2019
• Last Updated: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)