A Clinical Study of Vaginal Lubricant for Improvement of Vaginal Dryness
- Conditions
- Postmenopausal atrophic vaginitis,
- Registration Number
- CTRI/2018/01/011142
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
This is a Randomized Comparative, Open Label,2 Arm, Phase III Clinical Study to Evaluate the Safety and Efficacy ofEveGel for Improvement of Vaginal Dryness. In this study 40 female patientswith symptoms of vaginal dryness will be dispensed with either of the identicallooking gel’s(EveGel or Comparator) as per randomization and will be advised toapply a small amount of lubricant inside the vagina just before the sexualintercourse or as directed by the physician for a period of 4 weeks. Thepatients were assessed during the follow up visits (week 2 and week 4) throughclinical examination, Verbal Rating Scale (VRS), Female Sexual Function Index(FSFI) and Female Sexual Distress Scale –Revised (FSDS-R) in the improvement ofvaginal dryness during the study period. Safety assessment is done throughrecording adverse effects during follow up visits.
In the present clinical study, total of 40 womenwere studied. The age range of subjects included in the EveGel was 41.4±3.32 yearsand in the Comparator was 41.5±5 years(Table 1). Duration of treatment is completionof 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 reducedto 1.95±0.69 at week 2 with significance of a:p<0.017 and at week 4, thevalue 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 withsignificance of a:p<0.008 and at week 4, the value was 0.70±0.92 withsignificance of a:p<0.0001.(a: as compared to at entry).
The score for Vaginal and/or vulvarirritation/itching, in EveGel group, was 2.79±0.71 at entry which was reducedto 1.79±0.79 at week 2 with significance of a:p<0.0223 and at week 4, thevalue 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 withsignificance of a:p<0.0061 and at week 4, the value was 0.70±0.98 withsignificance of a:p<0.0001.(a: as compared to at entry). Other parameters like Dysuria, Dyspareunia showedthe significance of a:p<0.0491(week2) 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 tobaseline. The Desire frequency (number of times/week) in EveGel group, was 1.35±0.49at Baseline, which was increased to 2.15±0.67 at week 2 with significance of a:p<0.0428and at week 4, the value was 1.00±1.08 with significance of a:p<0.0001. InComparator group, the score was 1.55±0.51 at entry which was increased to 2.65±0.59at week 2 with significance of a:p<0.008 and q:p<0.0308. At week 4, thevalue was 3.39±1.04 with significance of a:p<0.0001.(a: as compared to atentry, q:as compared to EveGel).In EveGel group, the Desire level, was increasedto 2.15±0.67 at week 2 with significance of a:p<0.0428 and at week 4 thevalue 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 week4, with significance of a:p<0.0001. The Arousal level at week 2 hadsignificance of a:p<0.0273 and at week 4, the significance of a:p<0.0001.TheArousal Confidence, Satisfaction, frequency (number of times/week) had increasein values compared to baseline with the significance at week 2 and week 4. Otherparameters like Lubrication, Orgasm, satisfactionhad significance as compared to baseline values. The values for pain also hadreduction with significance at week 2 and week 4 as compared to baseline. Thescores of Female Sexual Distress Scale-Revised (FSDS-R) parameters like Distressedabout sex life, Unhappy, low sexual desire, Stressed, Angry, all showed significantimprovement with significance at week 2 and week 4.
In this study it was evident that patientscan safely use EveGel for managing vaginal dryness. The safety parameters areremained in normal range throughout the study period. No untoward side effectswere seen in any of the patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- 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) Visit 0- At entry visit, baseline | Visit 1- At the end of Week 2 | Visit 2- At the end of Week 4
- Secondary Outcome Measures
Name Time Method Incidence of adverse events (AEs) Safety and Tolerability of the study drug and patient compliance to therapy
Trial Locations
- Locations (1)
Sree Ayurved College
🇮🇳Nagpur, MAHARASHTRA, India
Sree Ayurved College🇮🇳Nagpur, MAHARASHTRA, IndiaDr Maya KamblePrincipal investigator9422556353maya_kamble@rediffmail.com