Proof Of Concept Menstrual Hygiene Product-Wondaleaf®

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02857972
• Date of registration: 02/08/2016
• Prospective Registration: No
• Primary sponsor: Clinical Research Centre, Malaysia
• Public title: Proof Of Concept Menstrual Hygiene Product-Wondaleaf®
• Scientific title: Proof of Concept Study of Wondaleaf® As an Alternative to Menstrual Hygiene Product for Night Use Among Menstruating Women
• Date of first enrolment: May 2016
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02857972
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Malaysia

Contacts

• Name: Vivian Wee Yen Tan
• Affiliation: Clinical Research Centre, Sibu Hospital, Sarawak State Health Department, Ministry of Health Malaysia

• Name: Teck Hock Toh
• Affiliation: Clinical Research Centre, Sibu Hospital, Sarawak State Health Department, Ministry of Health Malaysia

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Other Menstruation Disorders

Intervention(s)

Device: Wondaleaf®

Primary Outcome(s)

Preference [Time Frame: every night for one cycle of menstruation, an average of 5 days]

Secondary Outcome(s)

Satisfaction [Time Frame: every night for one cycle of menstruation, an average of 5 days]

Acceptability [Time Frame: every night for one cycle of menstruation, an average of 5 days]

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time Frame: every night for one cycle of menstruation till 3 months after last usage of investigational device]

Secondary ID(s)

NMRR-16-239-29465

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Twin Catalyst Sdn. Bhd.