Clinical Trial: Proof Of Concept Menstrual Hygiene Product-Wondaleaf®

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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 chang
Sponsor: Clinical Research Centre, Malaysia

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

Wondaleaf® usage during the night is better; same or worse as compared to usual sanitary pad usage during menstruation.


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

Wondaleaf® usage during the night is better; same or worse as compared to usual sanitary pad usage during menstruation.


Current Secondary Outcome:

  • Satisfaction [ Time Frame: every night for one cycle of menstruation, an average of 5 days ]
    Wondaleaf® 's comfort, cleanliness, capacity, convenience, appearance and quality on a 10-point sliding scale scoring with "1" for very poor to "5" being average up to "10" for very good as compare to experience of usual sanitary pads.
  • Acceptability [ Time Frame: every night for one cycle of menstruation, an average of 5 days ]
    Likert scale scoring with scores of "1" being not likely to"5" being very likely whether subjects will continue, recommend or buy the device in the future.
  • 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 ]
    Monitoring adverse event locally at the perineum, vaginal infection or discharge and/or urinary tract infections and recording all adverse events, serious adverse events, adverse device events and serious adverse device events throughout the therapy session and immediately following therapy: allergy to Wondaleaf® and any systemic reaction.


Original Secondary Outcome: Same as current

Information By: Clinical Research Centre, Malaysia

Dates:
Date Received: August 2, 2016
Date Started: May 2016
Date Completion:
Last Updated: February 1, 2017
Last Verified: February 2017