Proof Of Concept Menstrual Hygiene Product-Wondaleaf®
Proof Of Concept Menstrual Hygiene Product-Wondaleaf®
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®.
This is a proof of concept study to assess preference, satisfaction and acceptability of
 Wondaleaf® versus prior experience of sanitary pads for night use among menstruating women.
 Community sampling will be done and 30 women within ages of 18 to 45 years old with regular
 menstrual cycles will be recruited. Potential participants will be screened based on the
 inclusion and exclusion criteria.

 During the Visit 1 after recruitment, participants will have to complete the Baseline
 Questionnaire (Refer to Appendix):

 Table 1 - Socio-demographic: age, race, education level, marital and personal / family income
 status.

 Table 2 - Usual menstrual characteristics for the past 1 year: age of menarche; most frequent
 length of menstrual cycle (days); most frequent duration of each menstrual bleeding (days);
 number of days with heavy bleeding; the usual (i.e. commonest types) of sanitary pads used at
 night (panty liner, ultra-thin, regular, maxi / super or night use); estimated number of
 times hygiene product changed at night with heavy bleeding; estimated number of times hygiene
 product changed at night with average menstrual flow and current menstrual problems if any.

 Table 3 - satisfaction of usual sanitary pads usage: product comfort; cleanliness; capacity;
 convenience; appearance and quality.

 Participants will receive instructions and demonstrations regarding the investigational
 device usage. Any update on the device will be informed by research officers through phone
 call. Each women subject is required to use the investigational device given for the
 subsequent menstrual cycle at night and record the day of the menstrual flow starts and ends
 with the frequency of the device changed for each night in the Wondaleaf® Menstrual Diary.
 The test materials that are used shall be discarded appropriately in the usual manner at
 home.

 A Home-based Questionnaire on the safety of the investigational device has to be completed by
 the participants at home within 24 hours of the last usage of Wondaleaf®.

 Satisfaction, acceptability and preference questionaire will be given at Visit 2 at the end
 of menstrual cycle within 7 days following the last use of Wondaleaf®. Any unused
 investigational devices will be returned for counting purposes.

 A final follow up by a phone call to each subject will be performed to enquire their general
 well-being after 3 months (+/- 7 days) of last Wondaleaf® usage.

 If the women were confirmed pregnant during study duration, the subject will be withdrawn
 from the study and referred for antenatal care of their choice. If any adverse event arises,
 subject will be advised to stop using the investigational device and will be referred for
 medical care in the Hospital by relevant specialist.
Inclusion Criteria:

 1. 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

 2. Women who use sanitary pads as their only menstrual hygiene product.

 3. 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.

 4. Women who are able to understand instructions for correct use of study menstrual
 hygiene product (i.e. the investigational device).

 5. 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:

 1. Known history of vaginal or uterine infection(s), and/or urinary tract infections;
 these subjects can be rescreened after 14 days after successful treatment.

 2. 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.

 3. Female subject who is pregnant (established by urinary pregnancy test).

 4. Sensitivity or allergy to polyurethane and acrylic adhesive hypoallergenic.

 5. Staff who work directly under the investigators and/or employed directly by the device
 manufacturers, sponsor and study team.

 6. Moving outside Sibu area during study period and have difficulty to return for Visit
 2.

 7. 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.

 8. 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.

 9. Use of any medications which known to influence menstruation or study results for any
 reasons within 14 days, 30 days before Visit 1 and during the intended study duration.

 10. Subject participating in another clinical study involving menstrual hygiene device.

 11. Acute disease at the time of enrolment. Acute disease is defined as the presence of a
 moderate or severe illness with or without fever. Fever is defined as axillary /
 tympanic / rectal temperature ≥ 38°C. Subjects can be rescreened 14 days after the
 recovery;

 12. Blood dyscrasias, bleeding disorder, leukaemia, lymphomas of any type, or other
 malignant neoplasms affecting the bone marrow or lymphatic systems;

 13. Presence of a clinically significant disorder involving the cardiovascular,
 respiratory, renal, gastrointestinal, hepatic, immunologic, hematological, endocrine,
 or nervous system(s) or psychiatric disease or other conditions that may interfere
 with the health conditions (such as in case the women subject become pregnant), or
 would place the subjects at increased risk, as determined by the investigator(s).

 Significant is defined as any disease/condition that, in the opinion of the researcher,
 would put the subject's safety at risk through study participation, or which would confound
 the interpretation of the study results if the disease/condition exacerbated during the
 study.