Clinical study to evaluate efficacy and safety of Vimosa softgel capsule in vaginal dryness and vaginal prolapse – An open label, single arm, multi-center, interventional, prospective, clinical study

It is an open label, single arm, multi-center, interventional, prospective, clinical study to evaluate efficacy and safety of VIMOSA SOFTGEL CAPSULE in Vaginal Dryness and Vaginal Prolapse. The study will be carried out in 2 to 3 centers in India. There will be two cohorts in the study. In cohort I, subjects of vaginal dryness will be recruited and they will be asked to use VIMOSA Soft Gel Capsule once daily at night while going to bed for 30 days. In Cohort 2, subjects of uterine prolapse will be recruited and they will be asked to use VIMOSA Soft Gel Capsule once daily at night while going to bed for 90 days. The primary objective of Cohort I will be to assess change in Vaginal dryness using VAS on screening or baseline visit (Day 0), Visit 1 (Day 15) and Visit 2 (Day 30). The primary objective of cohort 2 will be to assess change in mass per vaginum from on screening or baseline visit (Day 0). Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90). The secondary objectives of the cohort 1 will be to assess change in itching, dyspareunia, burning, painful sex as assessed using VAS, change in pH of vagina, change in quality of life as assessed using WHO QOL BREF, requirement of rescue medications, global assessment of overall change as assessed by investigator and subjects, tolerability of the study product and adverse events and vitals on screening or baseline visit (Day 0), Visit 1 (Day 15) and Visit 2 (Day 30). The secondary objectives of the cohort 2 will be to assess changes in urinary incontinence, backache and lower abdominal discomfort, change in Pelvic Floor Distress Inventory Questionnaire (PFDIQ-20), change in quality of life as assessed using WHO QOL BREF, requirement of rescue medications, change in global assessment for overall change by subject and investigator, tolerability of the study product and adverse events and vitals screening or baseline visit (Day 0). Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90).

Results and Observations:

Cohort 1:

The study concludes that use of Vimosa soft gel capsules helped significantly in reducing Vaginal dryness with 15 days which continued further till 30 days. Other symptoms associated with dryness like itching burning sensation and pain also showed significant reduction. There was an improved libido and increased sexual satisfaction with the use of Vimosa soft gel capsules. No adverse events were reported with the regular use of Vimosa Soft Gel capsules. A significant improvement in quality of life was also observed with the use of Vimosa SGC.

Cohort 2:

In participants suffering from mild to moderate uterine-vaginal prolapse there was a significant reduction with a shift from moderate to mild and mild to no prolapse with the use of Vimosa soft gel capsules over a period of 90 days. Other symptoms associated with prolapse like urinary incontinence, backache and abdominal pain also showed significant reduction over the study period. Vimosa SGC were well tolerated for long term use over 90 days without producing any adverse effects. A significant improvement in quality of life was also observed with the use of Vimosa SGC.