Clinical trial: Proof Of Concept Menstrual Hygiene Product-Wondaleaf® (NCT02857972)

Eligibility criteria:
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.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Entailment