Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women.
Raktažodžiai
Santrauka
Datos
Paskutinį kartą patikrinta: | 06/30/2020 |
Pirmasis pateikimas: | 07/23/2020 |
Numatytas registravimas pateiktas: | 07/23/2020 |
Pirmas paskelbtas: | 07/26/2020 |
Paskutinis atnaujinimas pateiktas: | 07/23/2020 |
Paskutinis atnaujinimas paskelbtas: | 07/26/2020 |
Faktinė studijų pradžios data: | 08/31/2020 |
Numatoma pirminio užbaigimo data: | 09/29/2021 |
Numatoma studijų užbaigimo data: | 12/29/2021 |
Būklė ar liga
Intervencija / gydymas
Drug: Estrogen vaginal cream group (group A)
Radiation: Photobiomodutation group (group B)
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
Active Comparator: Estrogen vaginal cream group (group A) 22 participants will be included in this group. The participants selected for group A will be provided with estriol 0.01% vaginal cream, which should be applied at home. | Drug: Estrogen vaginal cream group (group A) The participants selected for group A will be provided with estriol 0.01% vaginal cream, which should be applied at home: 1 intravaginal applicator at night, daily for 2 weeks, followed by 2 times a week, on alternate days (Monday - Thursday) for another 2 weeks. |
Experimental: Photobiomodutation group (group B) 22 participants will be included in this group. The participants selected for group B will be undergo photobiomodulation with red LED. | Radiation: Photobiomodutation group (group B) The participants selected for group B will be undergo photobiomodulation with red LED. With the participant in the lithotomy position, the speculum will be introduced into the vaginal canal and a vaginal wash with 0.9% saline will be performed to remove secretions. Afterwards, the speculum will be removed and the device with a red LED inserted up to about 6 cm from the introitus. A non-lubricated condom will be used in the LED device for patient protection. Sessions will take place once a week for 4 weeks. |
Tinkamumo kriterijai
Tinkamos studijoms lytys | Female |
Priima sveikus savanorius | Taip |
Kriterijai | Inclusion Criteria: - postmenopausal women (amenorrhea for less than 12 months); - presence one or more symptoms of vulvovaginal atrophy (dyspareunia, dryness, irritation and vaginal burning); - Vaginal Heath Index ≤ 15 (signs of atrophy); - normal cytopathology of uterine cervix in the last year. Exclusion Criteria: - previous or current history of gynecological neoplasia; - who used hormonal or non-hormonal treatment for vulvovaginal symptoms of menopause; - current or recent genitourinary lesions or infectious processes in the genitourinary tract (last month); - current or recent (last month) systemic treatment with antifungals, antibiotics or corticosteroids; - presence of genital prolapse; - presence of contraindications to the use of vaginal estrogen (current, previous or suspected diagnosis of breast cancer, malignant estrogen-dependent tumors, uninvestigated uterine bleeding, untreated endometrial hyperplasia, deep venous thrombosis and current or previous pulmonary thromboembolism, known thrombophilia, recent or active arterial disease, acute liver disease, porphyria, use of drugs that may interact with estriol and hypersensitivity to the components of the vaginal cream formula). |
Rezultatas
Pirminės rezultatų priemonės
1. Objective assessment of improvement in vulvovaginal atrophy symptoms. [6 months]
2. Subjetive assessment of improvement in vulvovaginal atrophy symptoms. [6 months]
Antrinės rezultatų priemonės
1. Vaginal pH [6 months]
2. Female Sexual Function Index [6 months]
3. Vaginal Cell Maturation Index [6 months]