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Veronica Harsh, Anita H Clayton
PURPOSE OF REVIEW: Sex differences in the treatment of sexual dysfunction are partly due to neurobiological differences, as well as, the central and peripheral physiological effects of hormones and neurotransmitter actions on reproductive systems in men and women. Differences in epidemiology of complaints and diagnostic considerations, variance in medical comorbidities, and interference from related medications also contribute to the need for different strategies for treatments of sexual dysfunction according to gender...
March 14, 2018: Current Psychiatry Reports
Stephanie Wang Zuo, Harold Wu, Wen Shen
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...
March 12, 2018: Menopause: the Journal of the North American Menopause Society
Michele Carlo Schiavi, Valentina Sciuga, Andrea Giannini, Flaminia Vena, Ottavia D'oria, Giovanni Prata, Chiara Di Tucci, Delia Savone, Natalia Aleksa, Carmela Capone, Daniele Di Mascio, Maria Letizia Meggiorini, Marco Monti, Marzio Angelo Zullo, Ludovico Muzii, Pierluigi Benedetti Panici
The aim of this study was to assess the effectiveness of ospemifene in the improvement of sexual function in postmenopausal women with vulvovaginal atrophy (VVA) affected by overactive bladder syndrome (OAB) or urge urinary incontinence (UUI). One hundred five postmenopausal patients with VVA affected by OAB and/or UUI were enrolled for the study. All patients received ospemifene 60 mg for 12 weeks. Clinical examination, 3-d voiding diary and the vaginal health index (VHI) were performed at baseline and at 12 weeks...
February 20, 2018: Gynecological Endocrinology
Filippo Murina, Stefania Di Francesco, Silvia Oneda
The study aimed to assess the effects of ospemifene on vulvar vestibule in postmenopausal women with vulvar pain and dyspareunia. Fifty-five postmenopausal women used oral ospemifene 60 mg/d for 60 d. Symptoms of dryness, burning, and dyspareunia were evaluated on a 10 cm visual analog scale. Visual examination of the vulvar vestibule was also conducted. Patients also underwent current perception threshold (CPT) testing obtained from the vulvar vestibule. Fifty-five patients (94.6%) completed the treatment...
January 15, 2018: Gynecological Endocrinology
James A Simon, Corrado Altomare, Susannah Cort, Wei Jiang, JoAnn V Pinkerton
OBJECTIVE: To evaluate the safety of daily oral ospemifene 60 mg, estrogen agonist/antagonist, used to treat moderate-to-severe dyspareunia due to postmenopausal vulvovaginal atrophy, which is part of genitourinary syndrome of menopause. METHODS: Post hoc analysis of safety data (treatment-emergent adverse events [TEAEs]) pooled from six phase 2 and 3 randomized, double-blind, multicenter placebo-controlled studies, evaluating the effects of ospemifene 60 mg on the breast, cardiovascular system, and bone in postmenopausal women...
October 24, 2017: Journal of Women's Health
Jae Jun Shin, Seul Ki Kim, Jung Ryeol Lee, Chang Suk Suh
Ospemifene-a third-generation selective estrogen receptor modulator approved by the Food and Drug Administration in 2013-is an oral medication for the treatment of dyspareunia. In postmenopausal women with vulvovaginal atrophy, ospemifene significantly improves the structure and pH levels of the vagina, reducing dyspareunia. It is available as a 60-mg tablet; hence, women who may have had prior difficulty with vaginal administration or on-demand use of nonprescription lubricants and moisturizers would likely prefer this form of treatment...
August 2017: Journal of Menopausal Medicine
Michele Carlo Schiavi, Anna Di Pinto, Valentina Sciuga, Pierangelo Faiano, Chiara Di Tucci, Ottavia D'oria, Angela Martoccia, Giovanni Prata, Carlo Carraro, Rosa Ostuni, Marzio Angelo Zullo, Ludovico Muzii, Pierluigi Benedetti Panici
Aim of this study was to evaluate the efficacy of ospemifene in the prevention of recurrent lower urinary tract infections in postmenopausal women with vulvovaginal atrophy. The study have a retrospective design. Thirty-nine patients were enrolled. Patients underwent clinical examination and urine culture. The urinary symptoms and the quality of life were evaluated with UTISA score, PUF and SF-36 questionnaires before and after treatment. All 39 patients received ospemifene 60 mg one tablet/daily for 6 months...
August 30, 2017: Gynecological Endocrinology
Nicoletta De Rosa, Giada Lavitola, Pierluigi Giampaolino, Ilaria Morra, Carmine Nappi, Giuseppe Bifulco
BACKGROUND: Cervical cancer (CC) treatments impact quality of life (QoL) and sexual function (SF) of survivors. Treatment options to reduce sexual dysfunction are limited. The aim of this study was to assess the effectiveness of ospemifene in CC survivors with clinical signs and symptoms of vulvovaginal atrophy (VVA) focusing on their QoL and SF. MATERIALS AND METHODS: Fifty-two patients with previous diagnosis of stage I-IIa CC suffering from VVA and treated with ospemifene were enrolled into a single arm prospective study...
2017: BioMed Research International
Stefania Alvisi, Maurizio Baldassarre, Valentina Martelli, Giulia Gava, Renato Seracchioli, Maria Cristina Meriggiola
Ospemifene is a selective estrogen receptor modulator used for the treatment of vulvo-vaginal atrophy (VVA) in post-menopausal women. No direct evidence of its effects on histological features of the human vagina has been reported. To evaluate the effects of ospemifene on histological parameters, glycogen content, proliferation, and estrogen receptor α expression (ERα) of vaginal epithelium in post-menopausal women. Thirty-two post-menopausal women undergoing surgical procedures were enrolled. Sixteen subjects taking ospemifene at the time of inclusion (OSP) were compared to 16 subjects not taking any hormone (CTL)...
May 31, 2017: Gynecological Endocrinology
David F Archer, Corrado Altomare, Wei Jiang, Susannah Cort
OBJECTIVE: To evaluate the effect of ospemifene 60 mg on the lipid and coagulation parameters of postmenopausal women using data from five phase 2 and 3 clinical trials. METHODS: Data for lipids and coagulation factors for 2,166 postmenopausal women were pooled from five randomized, placebo-controlled studies. Lipid and coagulation parameters included in this analysis were total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), triglycerides, activated partial thromboplastin time (aPTT), fibrinogen, antithrombin antigen, protein C Ag, and protein S Ag free...
October 2017: Menopause: the Journal of the North American Menopause Society
Michele Carlo Schiavi, Marzio Angelo Zullo, Pierangelo Faiano, Ottavia D'Oria, Giovanni Prata, Vanessa Colagiovanni, Andrea Giannini, Chiara Di Tucci, Giorgia Perniola, Violante Di Donato, Marco Monti, Ludovico Muzii, Pierluigi Benedetti Panici
AIMS: The aim of this study was to assess the effectiveness and safety of ospemifene in the improvement of overactive bladder (OAB) symptoms in postmenopausal women affected by vulvovaginal atrophy (VVA). METHODS: Forty-six postmenopausal patients affected by VVA with OAB syndrome were enrolled for the study. All patients received Ospemifene 60 mg for 12 weeks. Clinical examination, 3-day voiding diary, urodynamic testing, ultrasound measurement of endometrial and bladder wall thickness (BWT) and the Vaginal Health Index (VHI) were performed at baseline and 12 weeks...
May 11, 2017: Gynecological Endocrinology
Rossella E Nappi, Filippo Murina, Giuseppina Perrone, Paola Villa, Nicoletta Biglia
Vulvar and vaginal atrophy (VVA) is a chronic medical condition in postmenopausal women, which is predominantly due to a permanent cessation of ovarian oestrogen production. Current available treatment options for VVA are over-the-counter (OTC) symptomatic relief products or local oestrogen therapy (LET) aiming to treat this underlying atrophic condition. Recent surveys indicated that these products decrease sexual spontaneity, are messy and indiscrete. Ospemifene is an oral daily drug, which has proven to treat vaginal dryness and dyspareunia effectively...
April 10, 2017: Minerva Ginecologica
P Antonio Maldonado, T Ignacio Montoya, Jesus F Acevedo, Patrick W Keller, R Ann Word
Although the positive effects of vaginal estrogens and the selective estrogen receptor modulator, ospemifene (OS), on the vaginal epithelium are well recognized, less is known regarding the effects of these therapies on the lower urinary tract or vaginal muscularis. Clinical evidence suggests that vaginally administered estrogen may improve overactive bladder-related symptoms. The objective of this study was to compare the effects of OS, vaginal conjugated equine estrogens (CEE), or both on the vaginal wall and lower urinary tract in a rat model of menopause...
January 1, 2017: Biology of Reproduction
N Bruyniks, N Biglia, S Palacios, A O Mueck
In the absence of a direct head-to-head study, we performed an indirect historical comparison of ospemifene 60 mg (Senshio(®)) vs. local vaginal estrogens in moderate or severe vulvar and vaginal atrophy (VVA). A literature search was carried out of clinical efficacy/safety trials of local vaginal estrogens in VVA approved in Europe. For efficacy comparison, studies had to be placebo-controlled and of 12 weeks' duration. For safety comparison, studies had to be ≥40 weeks' duration. Efficacy endpoints were the difference between active and placebo in change from baseline to week 12 for symptoms, vaginal pH, and maturation value (MV)...
June 2017: Climacteric: the Journal of the International Menopause Society
Ryuji Kubota, Sayaka Matsumoto, Toshihiro Wajima
PURPOSE: To develop a population pharmacokinetic (PPK) model to assess factors influencing ospemifene pharmacokinetics and to assess safety for pharmacokinetic alteration observed in drug development. METHOD: A PPK model was constructed using pooled ospemifene concentrations. Covariates considered before start of the analysis were: age, race, body weight, BMI, albumin, alanine amino-transferase, bilirubin, and creatinine clearance. The expected distribution of ospemifene concentration was derived for the 4 cases in phase-1 studies that increased ospemifene exposure: administration to severe renal impairment subjects (case 1), administration to moderate hepatic impairment subjects (case 2), coadministration with ketoconazole (case 3), or coadministration with fluconazole (case 4)...
April 2017: International Journal of Clinical Pharmacology and Therapeutics
Santiago Palacios, Pluvio J Coronado
Menopausal symptoms include vasomotor symptoms (VMS), vulvar-vaginal atrophy, and loss of bone mass associated with an increased risk of fracture. Treatment of VMS consists of lifestyle changes, hormone treatment (estrogens with and without progestogens, tissue selective estrogens complex or conjugated estrogens and bazedoxifene [CE/BZA], progestogens, and tibolone), and nonhormonal treatments. Genitourinary symptoms due to vulvar-vaginal atrophy are treated with systemic and local hormones, moisturizer creams and gels, CE/BZA, and a selective estrogen receptor modulator (ospemifene)...
April 2017: Minerva Ginecologica
D Ashley Hill, Mark Crider, Susan R Hill
The results of large clinical trials have led physicians and patients to question the safety of hormone therapy for menopause. In the past, physicians prescribed hormone therapy to improve overall health and prevent cardiac disease, as well as for symptoms of menopause. Combined estrogen/progestogen therapy, but not estrogen alone, increases the risk of breast cancer when used for more than three to five years. Therefore, in women with a uterus, it is recommended that physicians prescribe combination therapy only to treat menopausal symptoms such as vasomotor symptoms (hot flashes) and vaginal atrophy, using the smallest effective dosage for the shortest possible duration...
December 1, 2016: American Family Physician
Chiao-Jung Kao, Gregory T Wurz, Yi-Chen Lin, Daniel P Vang, Brian Phong, Michael W DeGregorio
OBJECTIVE: Ospemifene, an estrogen receptor agonist/antagonist approved for the treatment of dyspareunia and vaginal dryness in postmenopausal women, has potential new indications as an immune modulator. The overall objective of the present series of preclinical studies was to evaluate the immunomodulatory activity of ospemifene in combination with a peptide cancer vaccine. METHODS: Immune regulating effects, mechanism of action and structure activity relationships of ospemifene and related compounds were evaluated by examining expression of T-cell activating cytokines in vitro, and antigen-specific immune response and cytotoxic T-lymphocyte activity in vivo...
April 2017: Menopause: the Journal of the North American Menopause Society
Santiago Palacios, María Jesús Cancelo
The physiological decrease in vaginal estrogens is accountable for the emergence of vulvar and vaginal atrophy (VVA) and its related symptoms such as vaginal dryness, dyspareunia, vaginal and/or vulvar irritation or itching, and dysuria. The repercussion of these symptoms on quality of life often makes it necessary to initiate treatment. Up until now, the treatments available included vaginal moisturizers and lubricants, local estrogens, and hormonal therapy. However, therapeutic options have now been increased with the approval of 60 mg ospemifene, the first nonhormonal oral treatment with an agonist effect on the vaginal epithelium and an endometrial and breast safety profile which makes it unique...
2016: International Journal of Women's Health
L Del Pup
OBJECTIVE: Vaginal atrophy is a chronic, progressive medical condition that affects fifty percent of postmenopausal women, causing symptoms like dyspareunia, vaginal dryness, and vaginal irritation. Until recently, the only prescription options were systemic and vaginal estrogen therapies that might be limited by concerns about long-term safety and breast cancer risk. The objective is to analyze the literature about ospemifene, a tissue-selective estrogen receptor modulator (SERM) recently approved for the treatment of vulvovaginal atrophy and dyspareunia and to compare its effects with those of the other SERMs to assess its safety...
September 2016: European Review for Medical and Pharmacological Sciences
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