HIV Prevention Clinical Trial
Official title:
A Functional Performance Study of The Wondaleaf Female Condom
Verified date | October 2019 |
Source | University of Witwatersrand, South Africa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 220 |
Est. completion date | October 18, 2019 |
Est. primary completion date | October 18, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: 1. Be between the ages of 18 and 45 years (inclusive); 2. Be literate (able to read a newspaper or letter easily); 3. Be sexually active (defined as having at least two vaginal coital acts per week and not being abstinent in the month prior to enrolment); 4. Be in an exclusive (monogamous) sexual relationship with her spouse or partner while participating in this research study; 5. Have been in a sexual relationship with this partner for at least 6 months; 6. Not be a sex worker; 7. Not be pregnant (as determined by pregnancy testing) or planning a pregnancy during the time of the research study; 8. Be without observable evidence of Sexually Transmitted Infections (STI) as determined through syndromic diagnosis and vaginal examination; 9. 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); 10. Not be menopausal (defined as 12 months without menstruation); 11. Not have had a hysterectomy; 12. Not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms; 13. Willing to give informed consent; 14. Willing to complete the FC coital use logs; 15. Willing to use the study condoms as directed; 16. Willing to adhere to the follow-up schedule and all study procedures; 17. Willing to provide research study staff with an address, phone number or other locator information while participating in the study; and, 18. Willing to participate in the study for the duration of 10 condom uses (approximately 2-4 months. 19. Willing to have fingerprint scan to check for co-enrolment in other research projects Exclusion Criteria: - None specified |
Country | Name | City | State |
---|---|---|---|
South Africa | MatCH Research Unit [Maternal, Adolescent and Child Health Research Unit] | Durban | Kwa-Zulu Natal |
Lead Sponsor | Collaborator |
---|---|
Prof Mags Beksinska |
South Africa,
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. Epub 2007 Feb 7. — View Citation
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. Review. — View Citation
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. — View Citation
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Ting RS, Wong EL, Tnay JK. A pilot study on the functional performance and acceptability of an innovative female condom (Wondaleaf(®)) in Malaysia. Open Access J Contracept. 2018 Jan 24;9:11-20. doi: 10.2147/OAJC.S152505. eCollection 2018. — View Citation
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | Safety (Adverse Events) | Proportion of participants with symptoms of and proportion of Wondaleaf condom uses with reports of genitourinary irritation during or immediately after any of the 5 separate uses will be calculated. Medical and serious adverse events will be classified by relatedness, expectedness and severity. | 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 | Acceptability | Frequency of key acceptability endpoints will be calculated and include: comfort in use; ease of insertion and removal; like or dislike of product attributes; and adequacy and feel of lubrication | 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) |
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