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Proof Of Concept Menstrual Hygiene Product-Wondaleaf®

NCT02857972 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-02-03

No results posted yet for this study

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®.

Conditions

  • Other Menstruation Disorders

Interventions

DEVICE

Wondaleaf®

Use of Wondaleaf® during menstruation every night in one menstrual cycle.

Sponsors & Collaborators

  • Twin Catalyst Sdn. Bhd.

    collaborator INDUSTRY

  • Clinical Research Centre, Malaysia

    lead OTHER

Principal Investigators

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

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

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-10-31
Completion
2016-12-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02857972 on ClinicalTrials.gov