Health Condition 1: N952- Postmenopausal atrophic vaginitis Health Condition 2: null- Women with active sex lives of at least one sexual intercourse in a week and advised to use a standard contraceptive measure.
Conditions
Interventions
Intervention1: EveGel: small amount of lubricant inside the vagina just before the sexual intercourse frequency of at least once a week for 4 weeks duration.
Control Intervention1: standard comparator
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 1.Women with active sex lives of at least one sexual intercourse in a week 2.Women advised to use a standard contraceptive measure. 3.Women without a history of sensitivity to similar formulations 4.Subjects willing to sign informed consent and follow the study procedure.
Exclusion criteria
Exclusion criteria: 1.Women using other intravaginal gel moisturizer. 2.Women with disease or condition that, in the opinion of the gynecologist, could affect the test results. 3.Women using hormone replacement therapy in the last 3 months. 4.Absence of history or visible evidence of chronic skin disease or regional infections. 5.Women with genital herpes, vaginal infections or urinary tract infection. 6.Women diagnosed with cancer 7.Pregnant, lactating and women likely to become pregnant. 8.Personal history of allergy and hypersensitivity to any product of feminine hygiene. 9.Subjects with severe systemic illness like cardiovascular disorders, neurological disorders, renal disorders, autoimmune disorders. 10.Not willing to sign informed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of improvement of vaginal dryness symptoms Change of Verbal Rating Scale (VRS) total score from baseline to the end of the study To evaluate the differences from baseline to the end of the study of: Female Sexual Function Index (FSFI) and Female Sexual Distress Scale (FSDS-R)Timepoint: at end of week 2, end of week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events AE, Safety and Tolerability of the study drug and patient compliance to therapy Evaluation of local safety assessment,Ease and Comfort of using the productTimepoint: at end of week 2, end of week 4 | — |
Countries
India
Contacts
Public ContactDrPalaniyamma
The Himalaya Drug Company
Outcome results
None listed