Proof of Concept Study of Wondaleaf® As an Alternative to Menstrual Hygiene Product for Night Use Among Menstruating Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Preference
研究概览
简要总结
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®.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
Wondaleaf®
This is a single arm clinical trial, all female subjects will be recruited to the arm using investigational device only.
干预措施: Wondaleaf® (Device)
结局指标
主要结局
Preference
时间窗: 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.
次要结局
- Satisfaction(every night for one cycle of menstruation, an average of 5 days)
- Acceptability(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(every night for one cycle of menstruation till 3 months after last usage of investigational device)