Other Menstruation Disorders Clinical Trial
Official title:
Proof of Concept Study of Wondaleaf® As an Alternative to Menstrual Hygiene Product for Night Use Among Menstruating Women
| Verified date | February 2017 |
| Source | Clinical Research Centre, Malaysia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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®.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | December 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Malaysia | Sibu Hospital | Sibu | Sarawak |
| Lead Sponsor | Collaborator |
|---|---|
| Clinical Research Centre, Malaysia | Twin Catalyst Sdn. Bhd. |
Malaysia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Preference | Wondaleaf® usage during the night is better; same or worse as compared to usual sanitary pad usage during menstruation. | every night for one cycle of menstruation, an average of 5 days | |
| Secondary | 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. | every night for one cycle of menstruation, an average of 5 days | |
| Secondary | 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. | every night for one cycle of menstruation, an average of 5 days | |
| Secondary | 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. | every night for one cycle of menstruation till 3 months after last usage of investigational device |