Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women.

University of Nove de Julho

Status and phase: Withdrawn; Phase 2

Conditions: Vulvovaginal Atrophy

Treatments: Drug: Estrogen vaginal cream group (group A); Radiation: Photobiomodutation group (group B)

Study type: Interventional

Funder types: Other

Identifiers

NCT04487392

LEDATROPHY

Details and patient eligibility

About

Menopause is a physiological event and is defined as the loss of ovarian follicular activity, with consequent permanent cessation of menstrual cycles. Its diagnosis is made retrospectively after 12 months of amenorrhea, with no pathological cause involved. This period is marked by several changes in the female organism, mainly the genitourinary syndrome (GUS), which is a collection of signs and symptoms resulting from the state of hypoestrogenism. Almost half of postmenopausal women will experience symptoms of GUS, with vaginal dryness being the most prevalent, followed by dyspareunia and vulvovaginal irritation. The aim of the study is to evaluate the effect of photobiomodulation with red LED (ligth emitting diode) on the symptoms of vulvovaginal atrophy in postmenopausal women. A randomized and controlled clinical trial will be developed, which will include postmenopausal women with signs and symptoms of vulvovaginal atrophy. Participants will be allocated into two groups: those who will undergo photobiomodulation with intravaginal LED, and those who will receive vaginal cream with estriol. Objective and subjective improvement of atrophy will be assessed using the Vaginal Health Index and the visual analog scale, respectively. Vaginal pH, cell maturation index and changes in sexual function through the Female Sexual Function Index questionnaire will also be assessed. The variables will be analyzed at the time of admission, in one and three months after the intervention.

Sex: Female

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Estrogen vaginal cream group (group A)

Active Comparator group

Description:

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.

Treatment:

Drug: Estrogen vaginal cream group (group A)

Photobiomodutation group (group B)

Experimental group

Description:

22 participants will be included in this group. The participants selected for group B will be undergo photobiomodulation with red LED.

Treatment:

Radiation: Photobiomodutation group (group B)