NCT02857972

Proof Of Concept Menstrual Hygiene Product-Wondaleaf®

Proof of Concept Study of Wondaleaf® As an Alternative to Menstrual Hygiene Product for Night Use Among Menstruating Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Clinical Research Centre, Malaysia · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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®.

Detailed description

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.

Conditions

• Other Menstruation Disorders

Interventions

Type	Name	Description
DEVICE	Wondaleaf®	Use of Wondaleaf® during menstruation every night in one menstrual cycle.

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2016-08-05
• Last updated: 2017-02-03

Locations

1 site across 1 country: Malaysia