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Grossi FS, Balbinotti RR, Muller GC, Chagas LB, Tregnago AC, Kliemann LM, Magno VA, Binda MLMA, Vettorazzi J. Comparative efficacy of non-ablative radiofrequency and promestriene in management of the genitourinary syndrome and sexual dysfunction in cervical cancer survivors: a pilot randomized trial. J Sex Med 2025:qdaf083. [PMID: 40312849 DOI: 10.1093/jsxmed/qdaf083] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/26/2024] [Revised: 03/23/2025] [Accepted: 03/26/2025] [Indexed: 05/03/2025]
Abstract
BACKGROUND Radiotherapy for cervical cancer can lead to genitourinary syndrome (GUS), which negatively impacts sexual function and the quality of life among female cancer survivors. OBJECTIVE To evaluate the efficacy of promestriene and non-ablative radiofrequency (NARF) in treating GUS and its effects on sexual function in women who have undergone radiotherapy for cervical cancer (CC). METHOD In this pilot randomized clinical trial included 24 women who had received radiotherapy and/or brachytherapy for CC within the past five years. Participants were randomized to receive treatment with promestriene cream or intravaginal (NARF). Sexual function was assessed pre- and post-treatment using the Female Sexual Function Index (FSFI). Vaginal symptoms were evaluated using a visual analog scale (VAS), and histological analyses of vaginal biopsies were performed before and after the intervention. OUTCOMES The main outcomes measured were improvements in sexual function and reductions in vaginal symptoms. RESULTS Significant improvements in FSFI scores and reductions in vaginal symptom intensity were observed in both treatment groups. The median FSFI score increased from 13.0 to 23.1 after treatment. Histological analysis demonstrated a significant increase in epithelial thickness and an improvement in stromal quality in both groups. No significant differences were noted between the promestriene and (NARF) groups concerning sexual function improvements or symptom reduction. CLINICAL IMPLICATIONS Both promestriene and (NARF) proved effective and safe enhancing sexual function and reducing vaginal symptoms in post-radiotherapy CC survivors. STRENGTHS AND LIMITATIONS The study's strengths include its randomized design and comprehensive assessment of subjective and objective outcomes. However, the small sample size and limited follow-up period limit the generalization and long-term applicability of the findings. CONCLUSION Both promestriene and (NARF) significantly improve sexual function and alleviate vaginal symptoms in women treated with radiotherapy for CC, presenting viable options for managing GUS in this patient population.
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Affiliation(s)
- Fernanda Santos Grossi
- Postgraduate Program in Health Sciences: Gynecology and Obstetrics, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Rio Grande do Sul, 90610-264, Brazil
- Nucleus of Studies and Research in Sexuality of Rio Grande do Sul (NEPESEX), CNPq, Porto Alegre, Rio Grande do Sul, Brazil
- Obstetrics and Gynecology Service, Hospital Geral de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, 95070-561, Brazil
| | - Rodrigo Rossi Balbinotti
- Postgraduate Program in Health Sciences: Gynecology and Obstetrics, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Rio Grande do Sul, 90610-264, Brazil
| | - Gabriel Cardozo Muller
- Postgraduate Program in Epidemiology, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Rio Grande do Sul, 90610-264, Brazil
| | - Luciana Borges Chagas
- Nucleus of Studies and Research in Sexuality of Rio Grande do Sul (NEPESEX), CNPq, Porto Alegre, Rio Grande do Sul, Brazil
| | - Aline Caldart Tregnago
- Department of Pathology, Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil
| | - Lucia Maria Kliemann
- Postgraduate Program in Health Sciences: Gynecology and Obstetrics, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Rio Grande do Sul, 90610-264, Brazil
| | - Valentino Antônio Magno
- Department of Gynecology and Obstetrics, Faculty of Medicine (FAMED), Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, 90610-264, Brazil
- Obstetrics and Gynecology Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, 90410-000, Brazil
| | - Marcia Luiza Montalvao Appel Binda
- Department of Gynecology and Obstetrics, Faculty of Medicine (FAMED), Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, 90610-264, Brazil
- Obstetrics and Gynecology Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, 90410-000, Brazil
| | - Janete Vettorazzi
- Postgraduate Program in Health Sciences: Gynecology and Obstetrics, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Rio Grande do Sul, 90610-264, Brazil
- Nucleus of Studies and Research in Sexuality of Rio Grande do Sul (NEPESEX), CNPq, Porto Alegre, Rio Grande do Sul, Brazil
- Department of Gynecology and Obstetrics, Faculty of Medicine (FAMED), Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, 90610-264, Brazil
- Obstetrics and Gynecology Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, 90410-000, Brazil
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Cucciniello L, Miglietta F, Guarneri V, Puglisi F. Managing sexual health challenges in breast cancer survivors: A comprehensive review. Breast 2024; 76:103754. [PMID: 38820922 PMCID: PMC11170478 DOI: 10.1016/j.breast.2024.103754] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/20/2024] [Revised: 05/12/2024] [Accepted: 05/23/2024] [Indexed: 06/02/2024] Open
Abstract
The significant advancements in breast cancer management have led to an increase in the prevalence of breast cancer survivors. Despite their efficacy, these treatments can cause a variable range of side effects, significantly deteriorating the patients' quality of life. Sexual dysfunction, and in particular the genitourinary syndrome of menopause, represent one of the major causes of quality-of-life impairment among breast cancer patients, potentially affecting treatment adherence and compliance. If in the general population, hypoestrogenism-related symptoms are typically managed through systemic or topical estrogen administration, this approach is contraindicated in breast cancer patients for the potential increased risk of disease recurrence, urging the investigation of alternative measures. The aim of this review is to summarize the most up-to-date pharmacological and non-pharmacological interventions, as well as supportive measures, available for the management of sexual dysfunctions in breast cancer patients and survivors.
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Affiliation(s)
- Linda Cucciniello
- Department of Medicine, University of Udine, Udine, Italy; Department of Medical Oncology, Centro di Riferimento Oncologico di Aviano (CRO), IRCCS, Aviano, Italy.
| | - Federica Miglietta
- Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy; Istituto Oncologico Veneto - IOV IRCCS, Padova, Italy.
| | - Valentina Guarneri
- Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy; Istituto Oncologico Veneto - IOV IRCCS, Padova, Italy.
| | - Fabio Puglisi
- Department of Medicine, University of Udine, Udine, Italy; Department of Medical Oncology, Centro di Riferimento Oncologico di Aviano (CRO), IRCCS, Aviano, Italy.
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3
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Hussain I, Talaulikar VS. A systematic review of randomised clinical trials - The safety of vaginal hormones and selective estrogen receptor modulators for the treatment of genitourinary menopausal symptoms in breast cancer survivors. Post Reprod Health 2023; 29:222-231. [PMID: 37840298 DOI: 10.1177/20533691231208473] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/17/2023]
Abstract
Therapies utilised in breast cancer management have been found to induce or worsen the genitourinary symptoms of menopause (GSM), a group of physical symptoms associated with the systemic loss of estrogen. These symptoms are often undertreated due to concerns surrounding cancer recurrence, especially when considering treatments with possible pro-estrogenic effects. As breast cancer prognosis continues to improve, clinicians are increasingly focussing on managing these symptoms amongst survivors. This systematic review primarily aimed to determine the risk of breast cancer recurrence amongst survivors using vaginal hormones and selective estrogen receptor modulator therapies recommended for use in GSM in the United Kingdom amongst currently published randomised clinical trials (RCTs). The secondary aim was to determine whether these RCTs demonstrated a significant rise in serum estrogen levels following the use of these therapies. A literature search revealed three RCTs suitable for assessment, two evaluating vaginal estrogen and one evaluating vaginal DHEA treatment. Our review determined that amongst published RCTs, no studies have aimed to assess for breast cancer recurrence; however among the studies observing for serious adverse effects of vaginal estrogen preparations, none have reported an increased incidence. Furthermore, these studies did not report a persistent or significant increase in serum estrogen levels following the use of vaginal estrogen products and low concentration (3.25 mg/day) DHEA gel. Larger RCTs studying commonly used vaginal preparations and selective estrogen receptor modulator treatments for GSM over longer follow-up periods will be vital to better assess the risk of breast cancer recurrence in survivors receiving these treatments.
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Affiliation(s)
- Ishrat Hussain
- Institute of Women's Health, University College London, London, UK
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4
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Cetera GE, Merli CEM, Boero V, Caia C, Vercellini P. Topical estrogens for the treatment of superficial dyspareunia related to genitourinary syndrome of menopause in women with a history of endometriosis: A clinical dilemma. Eur J Obstet Gynecol Reprod Biol 2023; 288:12-17. [PMID: 37421742 DOI: 10.1016/j.ejogrb.2023.06.025] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/06/2023] [Revised: 06/20/2023] [Accepted: 06/26/2023] [Indexed: 07/10/2023]
Abstract
Estrogen withdrawal, which occurs with the cessation of ovulation, causes genitourinary syndrome of menopause in up to 50-85% of women. Symptoms may profoundly impact quality of life and sexual function, interfering with enjoyment of sex in up to three out of four individuals. Topical estrogens have been found to provide symptom relief with minimal systemic absorption and appear to be superior to systemic therapy as what regards genitourinary symptoms. However, conclusive data on their appropriateness in postmenopausal women with a history of endometriosis is not available and the hypothesis that exogenous estrogen stimulation may reactivate endometriotic foci or even promote their malignant transformation is still open. On the other hand, endometriosis affects around 10% of premenopausal women, many of which may be exposed to an acute hypoestrogenic depletion even before spontaneous menopause occurs. This considered, excluding on principle patients with a history of endometriosis from first-line treatment for vulvovaginal atrophy would mean excluding a considerable percentage of the population from adequate care. More robust evidence is urgently needed in these regards. Meanwhile, it would appear reasonable to tailor the prescription of topical hormones in these patients, taking into account the entity of symptoms and the impact such symptoms have on patients' quality of life, as well as the form of endometriosis and the possible risks hormonal may entail. Moreover, the application of estrogens on the vulva instead of the vagina could be efficacious, while outweighing the possible biological cost of hormonal treatment in women with a history of endometriosis.
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Affiliation(s)
- G E Cetera
- Gynecology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
| | - C E M Merli
- Gynecology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
| | - V Boero
- Gynecology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
| | - C Caia
- Gynecology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy
| | - P Vercellini
- Gynecology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy
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Merlino L, D’Ovidio G, Matys V, Piccioni MG, Porpora MG, Senatori R, Viscardi MF, Vitale A, Della Rocca C, on behalf of Policlinico Umberto I Collaborators. Therapeutic Choices for Genitourinary Syndrome of Menopause (GSM) in Breast Cancer Survivors: A Systematic Review and Update. Pharmaceuticals (Basel) 2023; 16:ph16040550. [PMID: 37111307 PMCID: PMC10142093 DOI: 10.3390/ph16040550] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/09/2023] [Revised: 03/21/2023] [Accepted: 03/29/2023] [Indexed: 04/09/2023] Open
Abstract
(1) Background: Genitourinary syndrome of menopause (GSM) is a medical condition that can affect breast cancer survivors (BCS). This is a complication that often can occur as a result of breast cancer treatment, causing symptoms such as vaginal dryness, itching, burning, dyspareunia, dysuria, pain, discomfort, and impairment of sexual function. BCS who experience these symptoms negatively impact multiple aspects of their quality of life to the point that some of them fail to complete adjuvant hormonal treatment; (2) Methods: In this systematic review of the literature, we have analyzed possible pharmacological and non-pharmacological treatments for GSM in BCS. We reviewed systemic hormone therapy, local hormone treatment with estrogens and androgens, the use of vaginal moisturizers and lubricants, ospemifene, and physical therapies such as radiofrequency, electroporation, and vaginal laser; (3) Results: The data available to date demonstrate that the aforementioned treatments are effective for the therapy of GSM and, in particular, vulvovaginal atrophy in BCS. Where possible, combination therapy often appears more useful than using a single line of treatment; (4) Conclusions: We analyzed the efficacy and safety data of each of these options for the treatment of GSM in BCS, emphasizing how often larger clinical trials with longer follow-ups are needed.
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Affiliation(s)
- Lucia Merlino
- Department of Maternal, Infantile and Urological Sciences, University of Rome La Sapienza, Viale del Policlinico 155, 00161 Rome, Italy
| | - Giulia D’Ovidio
- Department of Maternal, Infantile and Urological Sciences, University of Rome La Sapienza, Viale del Policlinico 155, 00161 Rome, Italy
| | - Viviana Matys
- Department of Maternal, Infantile and Urological Sciences, University of Rome La Sapienza, Viale del Policlinico 155, 00161 Rome, Italy
| | - Maria Grazia Piccioni
- Department of Maternal, Infantile and Urological Sciences, University of Rome La Sapienza, Viale del Policlinico 155, 00161 Rome, Italy
| | - Maria Grazia Porpora
- Department of Maternal, Infantile and Urological Sciences, University of Rome La Sapienza, Viale del Policlinico 155, 00161 Rome, Italy
| | - Roberto Senatori
- Italian Society of Colposcopy and Cervicovaginal Pathology (SICPCV), 00186 Rome, Italy
| | - Maria Federica Viscardi
- Department of Maternal, Infantile and Urological Sciences, University of Rome La Sapienza, Viale del Policlinico 155, 00161 Rome, Italy
| | - Antonio Vitale
- Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Cattolica del Sacro Cuore University, Largo A. Gemelli 8, 00168 Rome, Italy
| | - Carlo Della Rocca
- Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University, 04100 Latina, Italy
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Valadares ALR, Kulak Junior J, Paiva LHSDC, Nasser EJ, Silva CRD, Nahas EAP, Baccaro LFC, Rodrigues MAH, Albernaz MA, Wender MCO, Mendes MC, Dardes RDCDM, Strufaldi R, Bocardo RC, Pompei LDM. Genitourinary Syndrome of Menopause. REVISTA BRASILEIRA DE GINECOLOGIA E OBSTETRICIA : REVISTA DA FEDERACAO BRASILEIRA DAS SOCIEDADES DE GINECOLOGIA E OBSTETRICIA 2022; 44:319-324. [PMID: 35576939 PMCID: PMC9948134 DOI: 10.1055/s-0042-1748463] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 10/18/2022]
Affiliation(s)
| | | | | | - Elizabeth Jeha Nasser
- Departamento de Ginecologia e Obstetrícia, Faculdade de Medicina do ABC, Santo André, SP, Brazil
| | | | | | | | | | | | | | - Maria Célia Mendes
- Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, São Paulo, Brazil
| | | | - Rodolfo Strufaldi
- Departamento de Ginecologia e Obstetrícia, Faculdade de Medicina do ABC, Santo André, SP, Brazil
| | | | - Luciano de Melo Pompei
- Departamento de Ginecologia e Obstetrícia, Faculdade de Medicina do ABC, Santo André, SP, Brazil
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Lubián López DM. Management of genitourinary syndrome of menopause in breast cancer survivors: An update. World J Clin Oncol 2022; 13:71-100. [PMID: 35316932 PMCID: PMC8894268 DOI: 10.5306/wjco.v13.i2.71] [Citation(s) in RCA: 37] [Impact Index Per Article: 12.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/01/2021] [Revised: 09/19/2021] [Accepted: 01/17/2022] [Indexed: 02/06/2023] Open
Abstract
There is increasing attention about managing the adverse effects of adjuvant therapy (Chemotherapy and anti-estrogen treatment) for breast cancer survivors (BCSs). Vulvovaginal atrophy (VVA), caused by decreased levels of circulating estrogen to urogenital receptors, is commonly experienced by this patients. Women receiving antiestrogen therapy, specifically aromatase inhibitors, often suffer from vaginal dryness, itching, irritation, dyspareunia, and dysuria, collectively known as genitourinary syndrome of menopause (GSM), that it can in turn lead to pain, discomfort, impairment of sexual function and negatively impact on multiple domains of quality of life (QoL). The worsening of QoL in these patients due to GSM symptoms can lead to discontinuation of hormone adjuvant therapies and therefore must be addressed properly. The diagnosis of VVA is confirmed through patient-reported symptoms and gynecological examination of external structures, introitus, and vaginal mucosa. Systemic estrogen treatment is contraindicated in BCSs. In these patients, GSM may be prevented, reduced and managed in most cases but this requires early recognition and appropriate treatment, but it is normally undertreated by oncologists because of fear of cancer recurrence, specifically when considering treatment with vaginal estrogen therapy (VET) because of unknown levels of systemic absorption of estradiol. Lifestyle modifications and nonhormonal treatments (vaginal moisturizers, lubricants, and gels) are the first-line treatment for GSM both in healthy women as BCSs, but when these are not effective for symptom relief, other options can be considered, such as VET, ospemifene, local androgens, intravaginal dehydroepiandrosterone (prasterone), or laser therapy (erbium or CO2 Laser). The present data suggest that these therapies are effective for VVA in BCSs; however, safety remains controversial and a there is a major concern with all of these treatments. We review current evidence for various nonpharmacologic and pharmacologic therapeutic modalities for GSM in BCSs and highlight the substantial gaps in the evidence for safe and effective therapies and the need for future research. We include recommendations for an approach to the management of GSM in women at high risk for breast cancer, women with estrogen-receptor positive breast cancers, women with triple-negative breast cancers, and women with metastatic disease.
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Affiliation(s)
- Daniel María Lubián López
- Department of Mother and Child Health and Radiology, Faculty of Medicine, University of Cadiz, Cádiz 11100, Spain
- Department of Obstetrics and Gynecology Service, University Hospital of Jerez de la Frontera, Jerez de la Frontera 11407, Spain
- Department of Obstetrics and Gynecology, Hospital Viamed Bahía de Cádiz, Chiclana de la Frontera 11130, Cádiz, a Spain
- Department of Obstetrics and Gynecology, Hospital Quirónsalud Campo de Gibraltar, Los Barrios 11379, Cádiz, Spain
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Santos LPA, Bonduki CE, Dardes RDCDM, Heinke T, Patriarca MT. Effects of oxytocin versus promestriene on genitourinary syndrome: a pilot, prospective, randomized, double-blind study. Clinics (Sao Paulo) 2022; 77:100116. [PMID: 36194923 PMCID: PMC9531039 DOI: 10.1016/j.clinsp.2022.100116] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/09/2022] [Revised: 08/23/2022] [Accepted: 09/05/2022] [Indexed: 11/18/2022] Open
Abstract
OBJECTIVES In this pilot, prospective, randomized, double-blind study, the authors compared the efficacy of oxytocin with promestriene in improving vaginal atrophy of Genitourinary Syndrome of Menopause (GSM). METHODS A total of 51 postmenopausal women with symptoms of GSM were evaluated. They were randomized into two groups: oxytocin (25 patients) and promestriene (26 patients) and were evaluated before and after 90 days of treatment; the evaluation was based on the domains of the Female Sexual Function Index (FSFI) (lubrication, satisfaction, and pain during sexual intercourse), clinical visual examination, and vaginal wall thickness. RESULTS After the use of the medications, both groups showed significant improvement in the three evaluated FSFI domains (p < 0.05) and there was no significant difference between the groups (p > 0.05). On clinical examination, the medications improved all the evaluated parameters but without statistical significance (p > 0.05). The evaluation of the thickness of the vaginal epithelium showed that both treatments led to increase in the vaginal epithelium (p < 0.05); however, the efficacy of promestriene was higher than that of oxytocin (p < 0.05). CONCLUSIONS Both medications were effective, however, studies with larger samples and longer follow-ups are needed to confirm the clinical applicability.
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Affiliation(s)
| | - Claudio Emílio Bonduki
- Departamento de Ginecologia, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brasil
| | | | - Thais Heinke
- Departamento de Patologia, Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brasil
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Genazzani AR, Monteleone P, Giannini A, Simoncini T. Pharmacotherapeutic options for the treatment of menopausal symptoms. Expert Opin Pharmacother 2021; 22:1773-1791. [PMID: 33980106 DOI: 10.1080/14656566.2021.1921148] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022]
Abstract
Introduction: Menopausal symptoms can be very overwhelming for women. Over the years, many pharmacotherapeutic options have been tested, and others are still being developed. Hormone therapy (HT) is the most efficient therapy for managing vasomotor symptoms and related disturbances. The term HT comprises estrogens and progestogens, androgens, tibolone, the tissue-selective estrogen complex (TSEC), a combination of bazedoxifene and conjugated estrogens, and the selective estrogen receptor modulators, such as ospemifene. Estrogens and progestogens and androgens may differ significantly for chemical structure and can be delivered through different routes, thereby displaying various pharmacological and clinical properties. Tibolone, TSEC and SERM also exhibit unique pharmacodynamics that can be exploited to obtain distinctive therapeutic effects. Non-hormonal options fall mainly into the selective serotonin reuptake inhibitor (SSRI) and selective noradrenergic reuptake inhibitor (SNRI), GABA-analogue drug classes.Areas covered: Herein, the authors describe the pharmacokinetics and pharmacodynamics of hormonal (androgens, estrogens, progestogens, tibolone, TSEC, SERMs) and non-hormonal (SSRIs, SNRIs, Gabapentin, Pregabalin, Oxybutynin, Neurokinin antagonists) treatments for menopausal symptoms and report essential clinical trial data in humans.Expert opinion: Patient tailoring of treatment is key to managing symptoms of menopause. Physicians must have in-depth knowledge of the pharmacology of compounds to tailor therapy to the individual patient's characteristics and needs.
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Affiliation(s)
- Andrea R Genazzani
- Division of Obstetrics and Gynecology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
| | - Patrizia Monteleone
- Division of Obstetrics and Gynecology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
| | - Andrea Giannini
- Division of Obstetrics and Gynecology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
| | - Tommaso Simoncini
- Division of Obstetrics and Gynecology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
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Cagnacci A, Gallo M, Gambacciani M, Lello S. Joint recommendations for the diagnosis and treatment of vulvo-vaginal atrophy in women in the peri- and post-menopausal phases from the Società Italiana per la Menopausa (SIM) and the Società Italiana della Terza Età (SIGiTE). ACTA ACUST UNITED AC 2019; 71:345-352. [DOI: 10.23736/s0026-4784.19.04469-1] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
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Scavello I, Maseroli E, Di Stasi V, Vignozzi L. Sexual Health in Menopause. MEDICINA (KAUNAS, LITHUANIA) 2019; 55:E559. [PMID: 31480774 PMCID: PMC6780739 DOI: 10.3390/medicina55090559] [Citation(s) in RCA: 74] [Impact Index Per Article: 12.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 06/28/2019] [Revised: 08/28/2019] [Accepted: 08/29/2019] [Indexed: 02/07/2023]
Abstract
Sexual function worsens with advancing menopause status. The most frequently reported symptoms include low sexual desire (40-55%), poor lubrication (25-30%) and dyspareunia (12-45%), one of the complications of genitourinary syndrome of menopause (GSM). Declining levels of sex steroids (estrogens and androgens) play a major role in the impairment of sexual response; however, psychological and relational changes related with aging and an increase in metabolic and cardiovascular comorbidities should also be taken into account. Although first-line therapeutic strategies for menopause-related sexual dysfunction aim at addressing modifiable factors, many hormonal and non-hormonal, local and systemic treatment options are currently available. Treatment should be individualized, taking into account the severity of symptoms, potential adverse effects and personal preferences.
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Affiliation(s)
- Irene Scavello
- Andrology, Women's Endocrinology and Gender Incongruence Unit, Department of Experimental, Clinical, and Biomedical Sciences "Mario Serio", University of Florence, 50139 Florence, Italy
| | - Elisa Maseroli
- Andrology, Women's Endocrinology and Gender Incongruence Unit, Department of Experimental, Clinical, and Biomedical Sciences "Mario Serio", University of Florence, 50139 Florence, Italy
| | - Vincenza Di Stasi
- Andrology, Women's Endocrinology and Gender Incongruence Unit, Department of Experimental, Clinical, and Biomedical Sciences "Mario Serio", University of Florence, 50139 Florence, Italy
| | - Linda Vignozzi
- Andrology, Women's Endocrinology and Gender Incongruence Unit, Department of Experimental, Clinical, and Biomedical Sciences "Mario Serio", University of Florence, 50139 Florence, Italy.
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13
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Vaginal estrogen and mammogram results: case series and review of literature on treatment of genitourinary syndrome of menopause (GSM) in breast cancer survivors. Menopause 2018. [PMID: 29533365 DOI: 10.1097/gme.0000000000001079] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
Abstract
OBJECTIVE To examine mammographic density before and after at least 1 year of vaginal estrogen use in a small cohort of healthy postmenopausal women and women with a personal history of breast cancer. METHODS We extracted data via chart review of patients from a single practitioner's menopause specialty clinic in Baltimore, MD. Mammographic change was primarily determined via the Bi-RADS scoring system, including the Bi-RADS density score. In addition, we conduct a narrative review of the current literature on the usage of local estrogen therapy, and systemic and local alternatives in the treatment of genitourinary syndrome of menopause (GSM) in breast cancer survivors. RESULTS Twenty healthy postmenopausal women and three breast cancer survivors fit our inclusion criteria. Amongst these two groups, we did not find an increase in mammographic density after at least 1 year and up to 18 years of local vaginal estrogen. Ospemifene use in one patient did not appear to be associated with any change in Bi-RADS score. Our narrative review found little data on the effects of vaginal estrogen therapy or newer alternative systemic therapies such as ospemifene on mammographic density. CONCLUSIONS Low-dose vaginal estrogen use for 1 or more years in a small cohort of women with GSM did not appear to be associated with any changes in breast density or Bi-RADS breast cancer risk scores in the majority of study participants, including three breast cancer survivors. Larger long-term controlled clinical trials should be conducted to examine the effects of low-dose vaginal estrogen on mammographic density in women with and without a personal history of breast cancer. Furthermore, relative efficacy and risk of vaginal estrogen compared with other forms of treatment for GSM should also be studied in long-term trials.
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Oyarzún MFG, Castelo-Branco C. Local hormone therapy for genitourinary syndrome of menopause in breast cancer patients: is it safe? Gynecol Endocrinol 2017; 33:418-420. [PMID: 28277141 DOI: 10.1080/09513590.2017.1290076] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023] Open
Abstract
The genitourinary syndrome of menopause (GSM) is a frequent complaint among breast cancer (BC) survivors that lead to an important affection of their quality of life (QoL). Lifestyle measures such as smoking cessation or regular sexual activity are usually insufficient to significantly improve GMS and although therapies such as lubricants and polycarbophil moisturized gels are considered first-line therapies to alleviate symptoms of vulvovaginal atrophy, these non-hormonal options are not able to reverse atrophy once it occurs. Instead, this complaint is corrected by local estrogens. The estrogen vaginal treatment usually used to treat GSM, is an issue of concern in this group due to the possible negative effect over the BC outcomes. On the other hand, the worsening of QoL in these patients due to symptoms related to GSM can lead to discontinuation of hormone adjuvant therapies and therefore must be addressed properly. The goal of this review is to contribute to health care professionals to make an informed decision to care for their BC patients.
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Affiliation(s)
- María Fernanda Garrido Oyarzún
- a Department of Obstetrics & Gynecology and Reproductive Biology, Faculty of Medicine , Universidad de los Andes , Santiago , Chile and
| | - Camil Castelo-Branco
- b Clinic Institute of Gynecology, Obstetrics and Neonatology, Hospital Clinic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona , Barcelona , Spain
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Effects of preoperative vaginal estrogen therapy for the incidence of mesh complication after pelvic organ prolapse surgery in postmenopausal women: is it helpful or a myth? A 1-year randomized controlled trial. Menopause 2016; 23:740-8. [DOI: 10.1097/gme.0000000000000614] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
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Santen RJ. Vaginal administration of estradiol: effects of dose, preparation and timing on plasma estradiol levels. Climacteric 2014; 18:121-34. [DOI: 10.3109/13697137.2014.947254] [Citation(s) in RCA: 105] [Impact Index Per Article: 9.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
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Estrogènes locaux et hyperactivité vésicale : mythes et réalités. Prog Urol 2014; 24:720-1. [DOI: 10.1016/j.purol.2014.06.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/02/2014] [Accepted: 06/03/2014] [Indexed: 11/20/2022]
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