Performance and Safety Trial of an Innovative Female Condom (Wondaleaf®) (NCT02593214) | Clinical Trial Compass
CompletedNot Applicable
Performance and Safety Trial of an Innovative Female Condom (Wondaleaf®)
Malaysia21 participantsStarted 2015-08
Plain-language summary
General objective:
To assess the performance and safety profile of a novel innovative design of female condom (Wondaleaf®) among healthy married women.
Specific objectives :
* To determine the failure rate of Wondaleaf®, in terms of clinical breakage, non-clinical breakage, invagination, misdirection, and slippage.
* To determine the acceptability and satisfaction of use of Wondaleaf® by subjects and their spouses.
* To assess the safety profile of Wondaleaf®.
Who can participate
Age range
21 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Sexually active and legally married couples both between 21 and 45 years of age, and who have been in sexual relationship for at least 6 months;
* Married couples who are willing to participate (i.e. maintain sexually active and agree to have penile-vaginal intercourse with frequency sufficient to meet protocol requirements) and having signed informed consent form;
* Married women willing to have physical examination of the genitalia by the investigator (who is a medical doctor);
* Married women who are willing to take urine pregnancy test;
* Married couples who are planning to get pregnant, but do not mind delaying it;
* Married couples who are not planning for pregnancy soon, yet do not mind getting pregnant (however if found pregnant during the study period, study for the couple will be terminated);
* Married woman and/or her spouse who are on effective contraception (e.g. oral contraceptive, intrauterine device, injectable, patch), or female / male sterilisation methods before entering the study and able to maintain the contraception throughout the study period;
* Married couples who agree to use only study female condom during the time of participation;
* Married couples who are able to understand instructions for correct use of study female condoms;
* Married couples who agree not to use male condom when using the study female condom in a single sexual intercourse;
* Married couples who agree not to use drugs or non-study devices that affect sexua…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total female condom failure
Timeframe: Five uses of investigational devices, an average of one month