Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT05738733
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18 to 65 years (both inclusive) at the time of consent.
2. Sex: Healthy non-pregnant/non-lactating females
* Females of fertile reproductive age with a propensity to vulvo-vaginal infection (18 years to 40 years)
* Females in the pre-menopausal age group (41 years to 48 years)
* Females in the post-menopausal age group (49 years to 65 years)
3. The subject is with Nugent score ≤3.
4. The subject with an active sex life of at least 01 sexual intercourse in a week
5. The subject of childbearing potential must have a reported negative pregnancy during screening and the end of the study.
6. The subject without a history of sensitivity to similar products/formulations
7. The subject is willing to give written informed consent and is willing to follow the study procedures.
8. The subject is willing to abide by the study protocol and study restrictions including abstinence from the use of any other product besides the test product for intimate wash, lubricant or any other products during the study.
9. The subject is a personal lubricant user and agrees to replace her usual personal lubricant with the test product.
10. The subject of childbearing potential who is willing to use a highly effective method of contraception throughout the clinical investigation.
11. The subject is of childbearing potential, is practising and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
12. If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
13. The subject who agrees to have a gynaecological pelvic examination to ensure no significant disease findings and have intact skin and mucous in the test region assessed by the gynaecologist at all the relevant time points
Exclusion Criteria:
1. The subject used other intra-vaginal gel moisturizers during the study.
2. The subject with Nugent score \>3.
3. The subject who is diagnosed with cancer
4. The subject using hormone replacement therapy for the last 3 months
5. The subject has a history or visible evidence of chronic skin disease or regional infections, genital herpes, vaginal infections or urinary tract infections.
6. Pregnant or lactating, women who are likely to become pregnant.
7. The subject exhibits or reports gynecologic abnormalities or has had vaginitis within 60 days prior to study initiation.
8. Personal history of allergy and hypersensitivity to any product of feminine hygiene, severe systemic complications of viral infections, severe systemic illness like cardiovascular disorders, neurological disorders, renal disorders, and autoimmune disorders.
9. The subject with any form of chronic infection/ allergy/ disease which may influence the study result
10. The subject with bacterial vaginosis/candidiasis/mycotic infections
11. The subject participated in clinical studies or had received any investigational agent in the previous 30 days.
12. The subject is not willing to sign an informed consent form.
13. The subject is an employee at the site or a partner or first-degree relative of the Investigator.
14. The subject fails to satisfy the Investigator of fitness to participate for any other reason.
15. The subject has had previous episodes of vaginal bleeding of unknown origin within the last 6 months of the screening visit.
16. The subject showed vaginal prolapse and/or other medical conditions that could interfere with the study's conduct and participation.
17. The subject who has used any kind of systemic and/or local hormonal products for vaginal dryness or any other vaginal condition in the 3 months prior to screening
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05738733
Study Brief:
Protocol Section:
NCT05738733