This is a Randomized Comparative, Open Label, 2 Arm, Phase III Clinical Study to Evaluate the Safety and Efficacy of EveGel for Improvement of Vaginal Dryness. In this study 40 female patients with symptoms of vaginal dryness will be dispensed with either of the identical looking gel’s(EveGel or Comparator) as per randomization and will be advised to apply a small amount of lubricant inside the vagina just before the sexual intercourse or as directed by the physician for a period of 4 weeks. The patients were assessed during the follow up visits (week 2 and week 4) through clinical examination, Verbal Rating Scale (VRS), Female Sexual Function Index (FSFI) and Female Sexual Distress Scale –Revised (FSDS-R) in the improvement of vaginal dryness during the study period. Safety assessment is done through recording adverse effects during follow up visits.

In the present clinical study, total of 40 women were studied. The age range of subjects included in the EveGel was 41.4±3.32 years and in the Comparator was 41.5±5 years(Table 1). Duration of treatment is completion of 4 weeks.

The scores of Verbal Rating Scale (VRS) parameters: for Vaginal Dryness, in EveGel group, was 3.00±0.00 at entry which was reduced to 1.95±0.69 at week 2 with significance of a:p<0.017 and at week 4, the value was 1.00±1.08 with significance of a:p<0.0001. In Comparator group, the score was 3.00±0.00 at entry which was reduced to 1.60±0.68 at week 2 with significance of a:p<0.008 and at week 4, the value was 0.70±0.92 with significance of a:p<0.0001.(a: as compared to at entry).

The score for Vaginal and/or vulvar irritation/itching, in EveGel group, was 2.79±0.71 at entry which was reduced to 1.79±0.79 at week 2 with significance of a:p<0.0223 and at week 4, the value was 0.89±0.99 with significance of a:p<0.0001. In Comparator group, the score was 2.85±0.37 at entry which was reduced to 1.60±0.68 at week 2 with significance of a:p<0.0061 and at week 4, the value was 0.70±0.98 with significance of a:p<0.0001.(a: as compared to at entry). Other  parameters like Dysuria, Dyspareunia showed the significance  of a:p<0.0491(week 2) and a:p<0.0373 (week 4), in values as compared to entry in EveGel group.

The scores of Female Sexual Function Index (FSFI) parameters also showed the significance in values as compared to baseline. The Desire frequency (number of times/week) in EveGel group, was 1.35±0.49 at Baseline, which was increased to 2.15±0.67 at week 2 with significance of a:p<0.0428 and at week 4, the value was 1.00±1.08 with significance of a:p<0.0001. In Comparator group, the score was 1.55±0.51 at entry which was increased to 2.65±0.59 at week 2 with significance of a:p<0.008 and q:p<0.0308. At week 4, the value was 3.39±1.04 with significance of a:p<0.0001.(a: as compared to at entry, q:as compared to EveGel).In EveGel group, the Desire level, was increased to 2.15±0.67 at week 2 with significance of a:p<0.0428 and at week 4 the value was 3.05±0.94 with significance of a:p<0.0001. The Arousal frequency (number of times/week) at week 2 had significance of a:p<0.0061 and at week 4, with significance of a:p<0.0001. The Arousal level at week 2 had significance of a:p<0.0273 and at week 4, the significance of a:p<0.0001.The Arousal Confidence, Satisfaction, frequency (number of times/week) had increase in values compared to baseline with the significance at week 2 and week 4. Other parameters like Lubrication, Orgasm,  satisfaction had significance as compared to baseline values. The values for pain also had reduction with significance at week 2 and week 4 as compared to baseline. The scores of Female Sexual Distress Scale-Revised (FSDS-R) parameters like Distressed about sex life, Unhappy, low sexual desire, Stressed, Angry, all showed significant improvement with significance at week 2 and week 4.

In this study it was evident that patients can safely use EveGel for managing vaginal dryness. The safety parameters are remained in normal range throughout the study period. No untoward side effects were seen in any of the patients.