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 range21 Years – 50 Years
SexALL
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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…
What they're measuring
1
Total female condom failure
Timeframe: Five uses of investigational devices, an average of one month