Proof Of Concept Menstrual Hygiene Product-Wondaleaf®
Malaysia36 participantsStarted 2016-05
Plain-language summary
General objective:
To assess the preference and performance in terms of satisfaction and acceptability as well as safety profile of a novel innovative design of menstrual hygiene device (Wondaleaf®) during the night for menstruating women by comparing it to prior experience of the usual hygienic product for menstrual control, i.e. sanitary pads.
Specific objectives:
* To determine the preference of participants between Wondaleaf® and usual sanitary pads as a night use menstrual hygiene product.
* To determine the satisfaction of participants towards Wondaleaf® and usual sanitary pads as a night use menstrual hygiene product.
* To determine the acceptability of participants towards Wondaleaf® as a night use menstrual hygiene product.
* To determine the safety profile of the Wondaleaf®.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
âś“. Women within ages of 18 to 45 years old with good health and regular menstrual cycles with last menstrual cycle occurred within 5 weeks of enrolment; subjects can be rescreened after completion of menstrual cycle
âś“. Women who use sanitary pads as their only menstrual hygiene product.
âś“. Women who agree to use only the study menstrual hygiene device and not sanitary pads or other menstrual hygiene products for menstruation during the night time of study duration.
âś“. Women who are able to understand instructions for correct use of study menstrual hygiene product (i.e. the investigational device).
âś“. Literate women who can complete the study questionnaire on their own in a language of their choice which are English, Malay and Chinese; and attending all study visits.
Exclusion criteria
âś•. Known history of vaginal or uterine infection(s), and/or urinary tract infections; these subjects can be rescreened after 14 days after successful treatment.
âś•. Ongoing or past history of sexually transmitted disease, pelvic inflammatory disease, and/or injuries to the pelvis requiring surgical intervention and/or pelvic floor physiotherapy.
What they're measuring
1
Preference
Timeframe: every night for one cycle of menstruation, an average of 5 days
âś•. Female subject who is pregnant (established by urinary pregnancy test).
âś•. Sensitivity or allergy to polyurethane and acrylic adhesive hypoallergenic.
âś•. Staff who work directly under the investigators and/or employed directly by the device manufacturers, sponsor and study team.
âś•. Moving outside Sibu area during study period and have difficulty to return for Visit 2.
âś•. Female subjects who have menopause (absence of menstruation for more than 6 months in female) or any other circumstances that cause secondary amenorrhea (absence of menstruation for more than 6 months in a normal female of reproductive age that is not due to pregnancy) such as side effect from hormonal contraceptive.
âś•. Use any medications or preparation applied topically to the perineum or intravaginally to the genitalia but subjects can be rescreened 14 days after the recovery if the application is for acute illness.