An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of the Topical Formulation Ã¢â?¬Ë?Vagitone Intimate Hygiene Wash and Vagitone Vaginal GelÃ¢â?¬â?¢ in Female Subjects for Maintaining Vulvovaginal Health and Hygiene

Aimil Ayouthveda India Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1) Female subjects, 18 - 40 years of age.
•2) Willing to use Ã¢â?¬Ë?Vagitone Intimate Hygiene Wash and Vagitone Vaginal GelÃ¢â?¬• vaginally.
•3) Willing to refrain from the use of any vaginal estrogen, moisturizer, lubricant, prebiotic or probiotic, or soap in the vagina throughout the study duration.
•4) Willing to take their own vaginal samples.
•5) Willing to use effective contraception during the study period.
•6) Subjects who have had a consistent menstrual cycle for at
•least 3 months.
•7) Subjects who agree to sign written informed consent.
•8) Willing to provide information about their own medical and
•sexual histories.
•9) At least one of the following vaginal symptoms in the last 30 days. Dryness at least once a week, Itching at least once a week, Irritation at least once a week, Soreness /pain at least once a week, Discomfort before/after menstruation, and during
•ovulation, Pain associated during sexual activity

•1) Women who are currently pregnant or breastfeeding.
•2) Participants currently trying to conceive and not willing to use effective contraception for 30 days during study period.
•3) Participants with abnormal genital bleeding for an unknown reason.
•4) Participants who had undergone pelvic or vaginal surgery during the past two months.
•5) Participants used topical and/or oral antibiotics or antifungal therapy within the last 15 days.
•6) Participants with a disease that need frequent systemic antibiotic treatment during participation in the study.
•7) Participants with a known immunosuppressive disease or are presently taking immunosuppressants.
•8) Participants who have already participated in another drug or intervention trial.
•9) Participants having any other physiological or pathological conditions that the investigator would believe interfere with the study outcome.

发起方

Aimil Ayouthveda India Ltd