Results of open multi‑centre comparative randomized study of efficiency and safety of application of three therapeutic schemes of vaginal capsules Triogynal for treatment of vaginal atrophy in postmenopausal women

Objective: to compare the efficacy and safety of the use of three therapeutic regimens of Triogynal (vaginal capsules) for the treatment of atrophic vulvovaginitis in postmenopausal women.

Material and methods. The study included 201 women aged 46 to 65 years in postmenopause (at least 12 months after amenorrhea due to natural menopause, confirmed by laboratory determination of FSH concentration) with a diagnosis of atrophic vulvovaginitis. After screening, patients were randomized into three groups. The first one (n = 67) received Triogynal intravaginally, two capsules once a day for 20 days, then a capsule per day for 9 weeks, The second group (n = 67) received the drug intravaginally, two capsules one time per day for 20 days, then a capsule per day for 2 weeks, then a capsule two times a week for 7 weeks. The third group (n = 67) received the drug intravaginally, two capsules one time per day for 20 days, then a capsule two times a week for 9 weeks. The study evaluated changes in the vaginal maturation index (VIS), i. e. the primary endpoint, the dynamics of the vaginal health index, pH of the vagina, the severity of symptoms of atrophic vulvovaginitis on a five‑point Barlow scale, and the achievement of normal vaginal biocenosis after treatment.

Results. By the end of the course of therapy, the change in VIS was 23.94 ± 18.72 %, in patients of group 2 was 25.42 ± 21.84 %, in patients of group 3 was 25.52 ± 18.64 % (p > 0.05). The proportion of patients with a vaginal health index of 5 points did not differ at the end of the course of therapy (p > 0.05). As a result of a comparative analysis of the vaginal pH values, the severity of symptoms of atrophic vulvovaginitis on a five‑points Barlow scale in patients at the end of the course of therapy, data on similar efficacy were obtained (p > 0.05). Vaginal normocenosis was achieved in 68.2 % of patients in the first group, 57.6 % of patients in the second one, 60.0 % of patients in the third (p > 0.05).

Conclusion. All three therapeutic regimens for the use of Triogynal (vaginal capsules) for the treatment of atrophic vulvovaginitis have shown similar efficacy. The use of the drug in the regimen with the lowest course dosage according to the scheme two capsules once a day for 20 days, then one capsule twice a week for 9 weeks is most preferable due to the lower drug intervention, economic benefits and the convenience of therapy for the patient.

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