Health Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle
Conditions
Interventions
None listed
Sponsors
Aimil Ayouthveda India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Female subjects, 18 - 40 years of age. 2) Willing to use ââ?¬Ë?Vagitone Intimate Hygiene Wash and Vagitone Vaginal Gelââ?¬• 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the mean change from screening/baseline (day 1) to 30 days in the resolution of subject-reported vulvovaginal disorder symptoms as well as overall vulvovaginal health as measured by the Vulvovaginal Symptoms Questionnaire (VSQ, Scale 0-4) and Female Sexual Function Index (FSFI) pain domain (Scale 0-6) scores.Timepoint: Day 1 to Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of tolerability of ââ?¬Ë?Vagitone Intimate Hygiene Wash and Vagitone Vaginal Gelââ?¬â?¢ based on subject self-reported adverse events as well as answering the questionnaire during participant interviews.Timepoint: Day 1 to Day 30;Follow-up qualitative assessment (patient benefit survey questionnaire) of acceptance and satisfaction with ââ?¬Ë?Vagitone Intimate Hygiene Wash and Vagitone Vaginal Gelââ?¬â?¢ and mean change from screening/baseline (day 1) to 30 days.Timepoint: Day 1 to Day 30;Mean changes from baseline in vaginal pH levels (5, 5) and total microbial population after 30 days.Timepoint: Day 1 to Day 30;Prevalence of sexually transmitted infections (syphilis, gonorrhoea, chlamydia, trichomoniasis) at two evaluation points.Timepoint: Day 1 and Day 30 | — |
Countries
India
Contacts
Public ContactHasan Ali Ahmed
Xplora Clinical Research Services Pvt. Ltd.
Outcome results
None listed