AIM OF THE STUDY
To study the effect of intravaginal application of Multi-Gyn LiquiGel by vaginal pH changes; to assess preventive correction of the vulvovaginal discomfort after the gel application in patients with microdose combined oral contraceptive pills.
MATERIALS AND METHODS
We performed the non-interventional prospective study with 90 women of reproductive age, using combined oral contraceptive pills, whose the main complaint was a vulvovaginal discomfort. We randomized the female patients into two groups. Before the therapy start and after the end of the third month of application, all female patients were tested with instrumental, questionnaire survey and other special examinations. The methods were vaginal pH-metry with test strips «Kolpo-test pH» (Biosensor AN Ltd); video colposcopy with the Sensitec VC-200 machine; determination of symptom intensity of the vaginal atrophy according to the 5-point scale D. Barlow; assessment of the urogenital atrophy severity with the vaginal health index of G. Bachmann scale; use of questionnaire «Female sexual function index» (FSFI). The 1st female group (n=45) used the Multi-Gyn LiquiGel applications according to the scheme to correct the vaginal atrophy symptoms for 3 months. The group 2 (n=45) used an intimate water-based moisturizing lubricant with aloe extract (aloe vera extract, water, propylene glycol, hydroxyethylcellulose, benzoic acid, sodium saccharin, sodium hydroxide) only for the intercourse process. The results were assessed before the study start and after the end of the 3rd month research.
RESULTS
We estimated that after 3 months of using Multi-Gyn LiquiGel all female patients of the 1st group showed positive vaginal health dynamics established during the vaginal examination (increased elasticity and foldingness of the vaginal mucosa, sufficient moisture of vagina, normal vaginal epithelium). The vaginal pH level in women of the 1st and 2nd groups also showed its normal decreased numbers: in the 1st group — up to 4.16±0.04 compared with the 2nd group — 4.82±0.07 (p<0.02). The assessment of vaginal atrophy according to the 5-point scale D. Barlow in female patients of the 1st group was 0—1 points (1 point was only in 8 female patients — 17.8%), at the same time the changes in the female patients of the 2nd group were insignificant — 2 points were in 18 (40%) patients, in 23 (51.1%) — 1 point. The assessment of the FSFI showed that the female patients of the 1st group achieved a sexual comfort state, and in the 2nd group a low degree of sexual dysfunction was determined.
CONCLUSIONS
The study pointed that using of the non-hormonal drug Multi-Gyn LiquiGel to the initial manifestations of vulvovaginal discomfort (atrophy) in women of reproductive age concurrently combined oral contraceptive pills containing 3 mg drospirenone + 20 μg ethinylestradiol, improve clinical manifestations and some health indices. To sum up, the presented drug has the vaginal pH level corrective effect, might be perfectly used for the prevention and the treatment of mild urogenital atrophy concurrently combined oral contraceptive pills.