Study to Evaluate the Safety and Efficacy of the Topical Formulation ââ?¬Ë?Vagitone Intimate Hygiene Wash and Vagitone Vaginal Gelââ?¬â?¢ in Female Subjects for Maintaining Vulvovaginal Health and Hygiene

Phase 4

• Conditions: Health Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle

• Registration Number: CTRI/2022/08/045083
• Lead Sponsor: Aimil Ayouthveda India Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified