Hyaluronic acid and erbium laser for the treatment of genitourinary syndrome of menopause Tiziana Fidecicchi, Marco Gambacciani Climacteric, 2025 OBJECTIVE This study aimed to evaluate the effect of the vaginal erbium laser (VEL) in association with vaginal hyaluronic acid (HA) in postmenopausal women suffering from genitourinary syndrome of menopause (GSM). METHODS One hundred sexually active postmenopausal women were selected and divided into three groups using a block randomization method; 10 women declined to participate. The remaining women received three laser applications at 30-day intervals; 22 women dropped out for personal reasons or protocol violations. Group 1 (n = 25) received VEL treatment (XS Fotona Smooth®; Fotona, Slovenia) alone; Group 2 (n = 22) received daily vaginal HA tablets for 10 days after VEL treatment, followed by a twice a week administration during the follow-up period; and Group 3 (n = 21) received daily HA tablets for 10 days before the first VEL treatment and for 10 days after each laser application, followed by a twice a week administration for the follow-up period. Vaginal dryness and dyspareunia were assessed at the screening visit, before VEL treatment, after 1 and 3 months from the last laser treatment, using the visual analog scale. Data were analyzed using one-way analysis of variance and a linear mixed model for repeated measures. The post-hoc test for the interaction between time and treatment was performed using Bonferroni correction. RESULTS A significant (p < 0.001) improvement in both vaginal dryness and superficial dyspareunia was evident, with greater (p < 0.001) improvement in Group 2 and Group 3. CONCLUSIONS The results suggest that vaginal HA administration can improve the VEL effects on GSM in postmenopausal women.
Systemic hormone therapy after breast and gynecological cancers: an Italian expert group consensus opinion Angelo Cagnacci, Paola Villa, Giuseppina Paola Grassi, Nicoletta Biglia, Marco Gambacciani, et al. Climacteric, 2025 The specific Italian Group of Study of the Menopause formulated a consensus opinion on the use of estrogen therapy (ET) or combined estro-progestin hormone therapy (HT) after breast and gynecological cancers. This consensus is based on the risk of recurrence of the specific cancer during ET/HT, the presence of steroid receptors in cancer cells, the use of adjuvant hormone therapies and data on the use of ET/HT after cancer. The following positions were reached. ET/HT can be used after vulvar cancers and melanoma, but with great caution after the rare adenocarcinomas. ET/HT can be used after cervical cancer, but ET should be used with caution after adenocarcinomas. ET/HT can be used after International Federation of Obstetrics and Gynecology (FIGO) stage I-II estrogen-dependent endometrial cancers, except in Black women, and can probably be used after estrogen-independent endometrial cancers. ET/HT cannot be administered or should be used with great caution after most uterine sarcomas. ET/HT can probably be used after ovarian neoplasms except for granulosa cell tumors, and with great caution after low-grade serous ovarian carcinoma and serous borderline ovarian tumors. ET/HT can be used with great caution in women after estrogen receptor (ER)/progesterone receptor (PR)-positive breast cancer and is probably allowed after ER/PR-negative breast cancer.
Oestrogens in oral contraception: considerations for tailoring prescription to women’s needs Franca Fruzzetti, Tiziana Fidecicchi, Marco Gambacciani European Journal of Contraception and Reproductive Health Care, 2024 BACKGROUND The oestrogenic component of combined oral contraceptives (COCs) has changed over years with the aim of reducing oestrogen-related side effects and risks, whilst maintaining oestrogen beneficial effects, particularly on cycle control. PURPOSE To describe the pharmacological profiles of different oestrogens commonly used in COCs to provide insights on contraceptive prescription tailored to women's needs. RESULTS All COCs ensure a high contraceptive efficacy. COCs containing the natural oestrogens oestradiol (E2), oestradiol valerate (E2V) and estetrol (E4) have limited impact on liver metabolism, lipid and carbohydrate metabolism, haemostasis and sex hormone binding globulin levels, compared with ethinylestradiol (EE). COCs with E2 and E2V appear also to entail a lower elevation of the risk of venous thromboembolism vs. EE-containing pills. No epidemiological data are available for E4-COC. E2- and E2V-containing COCs seem to exert a less stabilising oestrogenic effect on the endometrium compared with EE-COCs. The E4-COC results in a predictable bleeding pattern with a high rate of scheduled bleeding and minimal unscheduled bleeding per cycle. Based on in vitro and in vivo animal data, E4 seems to be associated with a lower effect on cell breast proliferation. CONCLUSION Today various COCs contain different oestrogens. Prescribers must be familiar with the different properties of each oestrogen for a tailored contraceptive recommendation, considering their safety and contraceptive efficacy, as well as women's needs and preferences.
POESIT recommendations on management of body-identical hormones in menopausal symptoms Santiago Palacios, Cláudio Rebelo, Ana Casquilho, Ana Rosa Costa, Angelo Cagnacci, et al. Climacteric, 2024 Many women seek treatment to improve menopausal vasomotor symptoms (VMS). The selection of women most likely to benefit from menopause hormone therapy (MHT) is crucial in clinical practice. There is general agreement that women younger than 60 years or who initiate MHT within the first 10 years of menopause, with no contraindications, have greater benefits considering symptomatic relief and additional advantages. This group may have the advantage of protection from osteoporosis and from other chronic diseases that affect postmenopausal women, namely cardiovascular disease (CVD). Cumulating evidence supports MHT for symptomatic women. However, inadequate use according to the needs of symptomatic women led to a burden of suffering worldwide. In recent years, the emergent use of non-regulated body-identical hormones (non-rBHT) can expose patients to potential harms. These hormone preparations are not regulated through the same tests of safety, efficacy or dosing consistency as regulated-BHT (r-BHT). The POESIT (Portugal + Spain + Italy) recommendations highlight the use of 17β-estradiol (E2) and micronized progesterone (P4) as the real r-BHT. In addition, the group emphasizes as an example the data from the REPLENISH study with 1 mg E2/100 mg P4. The combination of the two hormones in one convenient pill showed a clear reduction or elimination of hot flashes and an improvement in sleep quality and, consequently, quality of life. At the same time, this combination has shown high rates of amenorrhea and no significant impact on lipid, glucose or coagulation parameters. Both the REPLENISH study and a real-life retrospective study pointed to the possibility of a lower risk of venous thromboembolism (VTE) with this formulation than with other combinations.
Recommendations on menopausal hormone replacement therapy Angelo Cagnacci, on behalf of the Executive Committee of the Italian Society of Menopause (SIM) and of the Italian Society of Gynecology of the Third Age (SIGiTE), Marco Gambacciani, Mario Gallo, Stefano Lello Minerva Ginecologica, 2019
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