Other Menstruation DisordersNCT02857972
Proof Of Concept Menstrual Hygiene Product-Wondaleaf®
A study testing Wondaleaf® in people with Other Menstruation Disorders, run by Clinical Research Centre, Malaysia at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Other Menstruation Disorders
- What is being tested?
- Wondaleaf®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMalaysia
- Study dates
- May 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Women who use sanitary pads as their only menstrual hygiene product.
- 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.
- Women who are able to understand instructions for correct use of study menstrual hygiene product (i.e. the investigational device).
- 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.
Who cannot join
- Known history of vaginal or uterine infection(s), and/or urinary tract infections; these subjects can be rescreened after 14 days after successful treatment.
- 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.
- Female subject who is pregnant (established by urinary pregnancy test).
- Sensitivity or allergy to polyurethane and acrylic adhesive hypoallergenic.
- Staff who work directly under the investigators and/or employed directly by the device manufacturers, sponsor and study team.
- Moving outside Sibu area during study period and have difficulty to return for Visit 2.
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- 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.
- 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.
- 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.
- Subject participating in another clinical study involving menstrual hygiene device.
- 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;
- Blood dyscrasias, bleeding disorder, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems;
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proof of Concept Study of Wondaleaf® As an Alternative to Menstrual Hygiene Product for Night Use Among Menstruating Women
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.
Read more
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®.
Read the 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
- Being tested
- Wondaleaf®
- Keywords
- Menstruation, Female Barrier, Sanitary pads
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wondaleaf®Device
Also called Female Barrier Film
Use of Wondaleaf® during menstruation every night in one menstrual cycle.
| Study group | Role | What they receive |
|---|---|---|
| Wondaleaf® | Experimental | This is a single arm clinical trial, all female subjects will be recruited to the arm using investigational device only. Receives: Device: Wondaleaf® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference
Wondaleaf® usage during the night is better; same or worse as compared to usual sanitary pad usage during menstruation.
Measured: every night for one cycle of menstruation, an average of 5 days
Secondary outcomes (3)
Satisfaction
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.
Measured: every night for one cycle of menstruation, an average of 5 days
Acceptability
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.
Measured: 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
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.
Measured: every night for one cycle of menstruation till 3 months after last usage of investigational device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Menstruation DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Centre, Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Twin Catalyst Sdn Bhd
- Responsible party
- Sponsor
- Investigators
- Teck Hock Toh, Principal investigator, Clinical Research Centre, Sibu Hospital, Sarawak State Health Department, Ministry of Health MalaysiaVivian Wee Yen Tan, Principal investigator, Clinical Research Centre, Sibu Hospital, Sarawak State Health Department, Ministry of Health Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857972
- Sponsor's protocol ID
- NMRR-16-239-29465
- Status last verified
- Feb 2017
- First submitted
- 2 Aug 2016
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Study of Wondaleaf® As an Alternative to Menstrual Hygiene Product for Night Use Among Menstruating Women
- ClinicalTrials.gov ID
- NCT02857972
- Acronym / sponsor ID
- NMRR-16-239-29465
- Conditions
- Other Menstruation Disorders
- Keywords
- Menstruation, Female Barrier, Sanitary pads
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Clinical Research Centre, MalaysiaUniversity, hospital or other
- Collaborators
- Twin Catalyst Sdn Bhd
- Study start
- May 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wondaleaf® | Experimental | Device: Wondaleaf®This is a single arm clinical trial, all female subjects will be recruited to the arm using investigational device only. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
- Women who use sanitary pads as their only menstrual hygiene product.
- 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.
- Women who are able to understand instructions for correct use of study menstrual hygiene product (i.e. the investigational device).
- 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.
Key exclusion criteria (14 listed)
- Known history of vaginal or uterine infection(s), and/or urinary tract infections; these subjects can be rescreened after 14 days after successful treatment.
- 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.
- Female subject who is pregnant (established by urinary pregnancy test).
- Sensitivity or allergy to polyurethane and acrylic adhesive hypoallergenic.
- Staff who work directly under the investigators and/or employed directly by the device manufacturers, sponsor and study team.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wondaleaf®Also: Female Barrier FilmUse of Wondaleaf® during menstruation every night in one menstrual cycle. | Device | Wondaleaf® |
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teck Hock Toh principal investigator
Clinical Research Centre, Sibu Hospital, Sarawak State Health Department, Ministry of Health Malaysia
Vivian Wee Yen Tan principal investigator
Clinical Research Centre, Sibu Hospital, Sarawak State Health Department, Ministry of Health Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wondaleaf® in people with Other Menstruation Disorders, run by Clinical Research Centre, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preference (time frame: every night for one cycle of menstruation, an average of 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017; AzTrials last refreshed its copy on 7 Nov 2026.