A Clinical Study of Vaginal Lubricant for Improvement of Vaginal Dryness
- Conditions
- Health Condition 1: N952- Postmenopausal atrophic vaginitis
- Registration Number
- CTRI/2018/01/011142
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Women with active sex lives of at least one sexual intercourse in a week
Women without a history of sensitivity to similar formulations
Subjects willing to sign informed consent and follow the study procedure.
Women using other intra vaginal gel moisturizer, diagnosed with cancer, Women using hormone replacement therapy in the last 3 months, Absence of history or visible evidence of chronic skin disease or regional infections, genital herpes, vaginal infections or urinary tract infection, Pregnant or lactating, women likely to become pregnant, 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, autoimmune disorders,Not willing to sign informed consent form
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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) <br/ ><br>Timepoint: Visit 0- At entry visit, baseline <br/ ><br>Visit 1- At the end of Week 2 <br/ ><br>Visit 2- At the end of Week 4 <br/ ><br>
- Secondary Outcome Measures
Name Time Method Incidence of adverse events (AEs) <br/ ><br>Safety and Tolerability of the study drug and patient compliance to therapyTimepoint: Visit 0- At entry visit, baseline <br/ ><br>Visit 1- At the end of Week 2 <br/ ><br>Visit 2- At the end of Week 4