-
Menopause (New York, N.Y.) Jan 2019To evaluate the safety and efficacy of ospemifene for the treatment of moderate to severe vaginal dryness in postmenopausal women with vulvovaginal atrophy (VVA). (Randomized Controlled Trial)
Randomized Controlled Trial
Efficacy and safety of ospemifene in postmenopausal women with moderate-to-severe vaginal dryness: a phase 3, randomized, double-blind, placebo-controlled, multicenter trial.
OBJECTIVE
To evaluate the safety and efficacy of ospemifene for the treatment of moderate to severe vaginal dryness in postmenopausal women with vulvovaginal atrophy (VVA).
METHODS
This 12-week, multicenter, double-blind phase 3 study randomized postmenopausal women (aged 40-80 years) with VVA and moderate to severe vaginal dryness as their most bothersome symptom to daily oral ospemifene 60 mg or placebo. Coprimary efficacy endpoints included changes from baseline to week 12 in percentages of vaginal parabasal and superficial cells, vaginal pH, and vaginal dryness severity with ospemifene versus placebo; other secondary endpoints were evaluated (weeks 4, 8, and 12). Safety was assessed by treatment-emergent adverse events (TEAEs) and endometrial biopsies.
RESULTS
Women (n = 631; ospemifene [n = 316], placebo [n = 315]) had a mean age of 59.8 years, a mean body mass index of 27.2 kg/m, and most were white. Ospemifene significantly improved (P < 0.0001) the percentages of parabasal and superficial cells, vaginal pH, and severity of vaginal dryness severity compared with placebo at week 12; significant between-group differences were noted by week 4. Secondary endpoints of dyspareunia (P < 0.001), maturation value (P < 0.0001), and the Female Sexual Function Index (P < 0.05) also significantly improved with ospemifene versus placebo at week 12. Significantly more women responded (31.5% vs 6.0%; P < 0.0001) or were satisfied (49.2% vs 33.8%; P = 0.0007) with ospemifene versus placebo at week 12. No unexpected TEAEs, treatment-related serious TEAEs, thrombotic events, or endometrial hyperplasia or carcinoma were observed.
CONCLUSIONS
Ospemifene was effective and well tolerated for the treatment of moderate-to-severe vaginal dryness in postmenopausal women with VVA.
Topics: Adult; Aged; Aged, 80 and over; Atrophy; Double-Blind Method; Dyspareunia; Female; Hot Flashes; Humans; Middle Aged; Patient Satisfaction; Postmenopause; Selective Estrogen Receptor Modulators; Severity of Illness Index; Tamoxifen; Treatment Outcome; Vagina; Vaginal Diseases; Vulva
PubMed: 30694917
DOI: 10.1097/GME.0000000000001292 -
Clinical and Experimental Rheumatology 2021The majority of women with primary Sjögren's syndrome (pSS) suffer from vaginal dryness, which negatively impacts daily and sexual activities. As little is known about...
OBJECTIVES
The majority of women with primary Sjögren's syndrome (pSS) suffer from vaginal dryness, which negatively impacts daily and sexual activities. As little is known about the aetiology and clinical context of this complaint, this study investigated the relationship between vaginal dryness and other clinical parameters associated with pSS.
METHODS
Female participants of the REgistry of Sjögren syndrome at UMCG - LongiTudinal (RESULT) cohort who fulfilled ACR-EULAR and/or AECG classification criteria for pSS were included, using baseline data for analyses. Patient-reported vaginal dryness (range 0-10) was correlated with demographic characteristics, systemic disease activity (i.e., ESSDAI), Sjögren's Syndrome Disease Damage Index, salivary and lacrimal gland function, patient-reported outcomes (ESSPRI, MFI), serology and quality of life (SF-36, EQ-5D). Significantly associated parameters (p<0.05) were corrected for potential confounders.
RESULTS
This cross-sectional study included 199 women with pSS; mean age was 52±14 years, 53% were postmenopausal, and median vaginal dryness score was 5 (IQR 2-7). Vaginal dryness was significantly associated with older age, postmenopausal status, peripheral neuropathy, oral and ocular dryness, ESSPRI and SF-36 mental and general health. After correction for age, menopausal status and medication use, peripheral neuropathy (B=1.632), oral dryness (B=0.302), and ocular dryness (B=0.230) were independently associated with vaginal dryness.
CONCLUSIONS
The independent association of vaginal dryness with oral and ocular dryness might imply that the aetiology of these symptoms is partly shared. Of all extraglandular features, only peripheral neuropathy was independently associated with vaginal dryness, suggesting that peripheral neuropathy plays a significant role in the pathology of vaginal dryness in pSS.
Topics: Adult; Aged; Cross-Sectional Studies; Female; Humans; Middle Aged; Quality of Life; Sjogren's Syndrome
PubMed: 34665706
DOI: 10.55563/clinexprheumatol/hzveng -
International Journal of Women's Health 2024Vulvar vaginal atrophy is a common condition affecting postmenopausal women, significantly impacting their quality of life. Fortunately, various treatment options are... (Review)
Review
Vulvar vaginal atrophy is a common condition affecting postmenopausal women, significantly impacting their quality of life. Fortunately, various treatment options are available, ranging from hormonal to non-hormonal therapies. Ospemifene has emerged as a promising non-hormonal alternative for managing vulvar vaginal atrophy. Its targeted approach, unique mechanism of action, favorable safety profile particularly for breast tissue, and efficacy make it a valuable option for women seeking relief from symptoms such as vaginal pain, dryness and dyspareunia and cannot receive estrogen supplementations. This is particularly the case for breast cancer survivors or women with a significant family history of estrogen-dependent cancers. Hence, tailored treatment plans, considering individual preferences and health circumstances, are essential in optimizing outcomes and improving the overall well-being of affected individuals.
PubMed: 38855356
DOI: 10.2147/IJWH.S431520 -
BMC Women's Health Sep 2023To evaluate the effect of erbium-YAG laser on the number of vaginal lactobacilli in postmenopausal women. (Randomized Controlled Trial)
Randomized Controlled Trial
PRIMARY OBJECTIVE
To evaluate the effect of erbium-YAG laser on the number of vaginal lactobacilli in postmenopausal women.
SECONDARY OBJECTIVES
To evaluate the effect of erbium-YAG laser on vaginal atrophy symptoms and vaginal pH in postmenopausal women.
MATERIALS AND METHODS
A total of 44 postmenopausal women who met the inclusion criteria were randomized in the laser group (n = 22) and sham group (n = 22). Vaginal lactobacilli grading, vaginal pH, vaginal atrophy score, and vaginal atrophy symptoms were assessed before and after treatment with erbium-YAG laser for two consecutive times, with a four-week interval; the results were compared with the effects of the sham procedure. Any adverse events after the treatment were recorded.
RESULTS
A total of 44 women were included, and five were lost to follow-up. Compared with sham procedure, vaginal lactobacilli grading improved in the laser group (5/20 in the laser group and 1/19 in the sham group). However, the improvement did not reach statistical significance (adjusted odds ratio = 5.32, 95% CI = 0.5-56.21). Vaginal atrophy symptoms measured by the visual analog scale (VAS) and vaginal pH were improved in both groups without a statistically significant difference between the two groups. Vaginal "dryness" VAS and vaginal atrophy score after treatment were significantly lowered in the laser group compared with the sham group.
CONCLUSIONS
This study showed an improvement in vaginal lactobacilli grading after vaginal laser treatment. However, the difference in vaginal lactobacilli grading after treatment in both groups was not statistically significant.
Topics: Female; Humans; Lasers, Solid-State; Erbium; Postmenopause; Lactobacillaceae; Atrophy
PubMed: 37752478
DOI: 10.1186/s12905-023-02590-y -
Breast Cancer Research and Treatment 2007The impact of improved treatments for the management of hormone-sensitive breast cancer extends beyond clinical responses. Thanks to appropriate literature and access to... (Review)
Review
The impact of improved treatments for the management of hormone-sensitive breast cancer extends beyond clinical responses. Thanks to appropriate literature and access to the internet, patient awareness of treatment options has grown and patients are now, in many cases, able to engage their oncologists in informed conversations regarding treatment and what to expect in terms of efficacy and safety. Indeed, patients realize that although there is no cure for metastatic disease, treatment can greatly reduce the risk of progression and in the adjuvant setting, where treatment is administered with a curative intent, current treatment options reduce the risk of relapse. The approval of letrozole throughout the breast cancer continuum has provided patients with many reassuring options. The improvement in outcome with letrozole is achieved without a detrimental effect on overall quality of life. Adverse events such as hot flushes, arthralgia, vaginal dryness, and potential osteoporosis are most significant from the patient's perspective, and it is important that caregivers pay attention to patients experiencing these events, as they can impact compliance unless effectively explained and managed. The major benefits of letrozole are to improve prospects for long-term survivorship in the adjuvant setting and to delay progression and the need for chemotherapy in the metastatic setting.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents, Hormonal; Aromatase Inhibitors; Breast Neoplasms; Chemotherapy, Adjuvant; Disease-Free Survival; Female; Humans; Letrozole; Middle Aged; Neoadjuvant Therapy; Neoplasm Recurrence, Local; Neoplasms, Hormone-Dependent; Nitriles; Patient Education as Topic; Postmenopause; Quality of Life; Selective Estrogen Receptor Modulators; Tamoxifen; Triazoles
PubMed: 17912639
DOI: 10.1007/s10549-007-9703-8 -
Taiwanese Journal of Obstetrics &... Sep 2023To evaluate the efficacy of daily vaginal gel containing hyaluronic acid (HA) and Biosaccharide Gum-1 (BG-1) on vulvovaginal atrophy (VVA) and on sexual function and...
OBJECTIVE
To evaluate the efficacy of daily vaginal gel containing hyaluronic acid (HA) and Biosaccharide Gum-1 (BG-1) on vulvovaginal atrophy (VVA) and on sexual function and quality of life (QoL).
MATERIALS AND METHODS
One hundred-four postmenopausal women with VVA were enrolled in the nonrandomized comparison cohort study. Of them, 50 women on HA/BG-1 participated in the study group and 54 women on lubricants/moisturizers on-demand as a control group. The primary endpoint was the efficacy of the vaginal gel on VVA evaluated by the Vaginal Health Index (VHI) score. Secondary endpoints included sexual behavior by the self-administered female sexual function index (FSFI) questionnaire, and quality of life (QoL), by the Short Form-36 questionnaire (SF-36).
RESULTS
All symptoms of AVV improved after 12 weeks of treatment in women on HA/BG-1. The VMI, although improved at the 12-week follow-up compared to baseline, it connoted a low estrogenic stimulation value. Sexual function improved significantly in women on HA/BG-1. Moreover, women reported a significant improvement in the somatic aspects of QoL. No benefits were obtained by the women in the control group.
CONCLUSIONS
Treatment with HA/BG-1 could have used in postmenopausal women who complain of vaginal dryness. The amelioration of VVA-related signs could improve sexual function and QoL.
Topics: Humans; Female; Cohort Studies; Hyaluronic Acid; Postmenopause; Quality of Life; Vaginal Creams, Foams, and Jellies; Sexual Behavior
PubMed: 37678998
DOI: 10.1016/j.tjog.2023.07.011 -
PloS One 2022This prospective, open-label, multicentre, multinational, randomised trial investigated the non-inferiority of treatment with a vaginal hormone-free moisturising cream... (Randomized Controlled Trial)
Randomized Controlled Trial
This prospective, open-label, multicentre, multinational, randomised trial investigated the non-inferiority of treatment with a vaginal hormone-free moisturising cream compared to a vaginal estriol (0.1%) cream in a panel of post-menopausal women suffering from symptoms of vulvovaginal dryness in a parallel group design. In total, 172 post-menopausal women were randomly allocated to either one of the two treatments, each administered for 43 days. The primary endpoint was the total severity score of subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse) of the respective treatment period. Secondary endpoints were severity of single subjective symptoms (including dyspareunia if sexually active), impairment of daily life, Vaginal Health Index, as well as assessment of safety. In both groups, women treated with hormone-free moisturising cream and those treated with estriol cream, total severity score improved significantly compared to baseline by 5.0 (from 6.1 to 1.1) and by 5.4 (from 6.0 to 0.6), respectively, after 43 days of treatment (p < 0.0001). One-sided test of baseline differences (for a clinically relevant difference Δ = 1.5) confirmed the hormone-free moisturising cream to be non-inferior to the estriol cream. Severity of dyspareunia as well as impairment of daily life due to subjective symptoms, significantly improved for both treatment groups (p<0.0001). Subgroup analysis of women with mild or moderate impairment of daily life at baseline caused by "vaginal dryness" symptoms benefited from both creams, while women with severe impairment showed a significantly greater benefit from the estriol cream (p = 0.0032). Both treatments were well tolerated with no serious adverse events occurring. This study provides clinical evidence that a hormone-free vaginal moisturising cream cannot only improve vaginal dryness compared to an 0.1% estriol cream but also can relieve dyspareunia as well as improve woman's impairment of daily life, justifying its use as a first choice for mild or moderate vulvovaginal dryness symptoms.
Topics: Administration, Intravaginal; Atrophy; Dyspareunia; Estriol; Female; Humans; Postmenopause; Prospective Studies; Treatment Outcome; Vagina; Vaginal Creams, Foams, and Jellies; Vaginal Diseases
PubMed: 35551533
DOI: 10.1371/journal.pone.0266633 -
Sexual Medicine Apr 2023Human T-lymphotropic virus type-1 (HTLV-1) causes a variety of sicca symptoms, including xeroderma, xerostomia, and xerophthalmia.
BACKGROUND
Human T-lymphotropic virus type-1 (HTLV-1) causes a variety of sicca symptoms, including xeroderma, xerostomia, and xerophthalmia.
AIM
We sought to evaluate vaginal dryness via the degree of perceived vaginal lubrication, vaginal hormonal cytology, and direct measurements of vaginal wetting.
METHODS
The research was designed as a cross-sectional study. Vaginal dryness was assessed by scores in the lubrication domain of the Female Sexual Function Index (FSFI) questionnaire and the Vaginal Maturation Index (VMI) determined by vaginal hormonal cytology, as well as the measurement of vaginal lubrication using Schirmer strips placed at the anterior vaginal wall. Medians (25th-75th percentiles) were calculated for each group and compared using a nonparametric Kruskal-Wallis test and the Dunn-Bonferroni post hoc method.
OUTCOMES
Outcomes were detection of the presence of vaginal dryness in women who were infected or noninfected with HTLV-1.
RESULTS
HTLV-1-infected women ( = 72, 57 asymptomatic and 15 with HTLV-1-associated myelopathy/tropical spastic paraparesis [HAM/TSP]) and uninfected women ( = 49) were studied. Women with HAM/TSP had significantly lower FSFI lubrication scores than asymptomatic and uninfected women ( = .032). In addition, women with HAM/TSP had significantly lower VMI compared with the asymptomatic and uninfected groups ( = .027 and = .039, respectively).
CLINICAL IMPLICATIONS
The results of this study show a reduction in vaginal lubrication in HTLV-1-infected women diagnosed with HAM/TSP compared with asymptomatic and uninfected women.
STRENGTHS AND LIMITATIONS
The lack of a gold standard test for the diagnosis of vaginal dryness and the fact that no assessment of vaginal pH was performed were limitations of this study. The strength of the study was the comprehensive assessment of vaginal dryness from several perspectives: subjective (perception of vaginal lubrication according to the vaginal lubrication domain of the FSFI), hormonal (vaginal hormonal cytology to assess local hormone status), and the degree of vaginal moisture (direct measurement of vaginal dryness with an instrument, the Schirmer strip, already used to measure the presence of dry eye).
CONCLUSION
HTLV-1-infected women with HAM/TSP have decreased vaginal lubrication compared with asymptomatic and uninfected women after adjusting for age.
PubMed: 37082722
DOI: 10.1093/sexmed/qfad002 -
The Journal of Sexual Medicine Sep 2022Sexual dysfunction is common in those affected by cancer and local and radical treatments for Bladder Cancer (BC) can affect sexual function directly.
BACKGROUND
Sexual dysfunction is common in those affected by cancer and local and radical treatments for Bladder Cancer (BC) can affect sexual function directly.
AIM
To evaluate sexual function following a bladder cancer (BC) diagnosis.
METHODS
Self-reported sexual function was collected 10 years after a diagnosis of BC as part of a cross-sectional patient reported outcome measure (PROM) survey exploring life after BC diagnosis and treatment.
OUTCOMES
Participants completed a combined EORTC QLQ-BLM30 and QLQ-NMIBC24 questionnaire, including questions on sexual activity, intimacy, erectile/ejaculatory function and vaginal dryness.
RESULTS
A total of 1796 participants returned a completed survey out of 3279 eligible participants (55%). Of the participants who returned a completed survey, a total of 1530 (85%) participants answered sexual function questions. The median (IQR) age was 75 (70-81). Participants were predominantly men (78%) and married/in civil partnerships (66%). In total, 31% were sexually active. Vaginal dryness was common (66%) in women. Erectile and ejaculatory dysfunction (80% and 58% respectively) were common in men. Compared to TURBT +/- intravesical treatments, those who had radical treatment were less likely to be sexually active (adjusted OR 0.56, 95% CI: 0.44-0.72, P<0.001) and had worse mean scores for intimacy problems (29.1 [radical treatment] vs 12.1, P<0.001), male sexual problems (72.2 [radical treatment] vs 45.7, P<0.001) and overall sexual function (17.1 [radical treatment] vs 20.3, P=0.01).
CLINICAL IMPLICATIONS
These findings highlight the magnitude of sexual dysfunction in the BC patient cohort and can help inform patients during the pre-op counselling process and shared decision making prior to BC treatments.
STRENGTHS AND LIMITATIONS
This study provides the largest in-depth analysis of sexual activity and function after BC diagnosis and treatment, to date. Limitations include the lack of data on participants' sexual function prior to BC treatment and the heterogeneity with respect to time passed since last BC treatment.
CONCLUSION
Sexual dysfunction in BC patients is common and rates appear higher following radical treatments compared to endoscopic. It is important to elicit these problems in clinics to enable counselling and treatment. Jubber I, Rogers Z, Catto JWF, et al. Sexual Activity, Function and Dysfunction After a Diagnosis of Bladder Cancer. J Sex Med 2022;19:1431-1441.
Topics: Cross-Sectional Studies; Erectile Dysfunction; Female; Humans; Male; Sexual Behavior; Sexual Dysfunction, Physiological; Sexual Partners; Surveys and Questionnaires; Urinary Bladder Neoplasms
PubMed: 35871051
DOI: 10.1016/j.jsxm.2022.06.016 -
Frontiers in Reproductive Health 2021Genitourinary syndrome of menopause (GSM) is a term used to define a compilation of signs and symptoms arising from decreased estrogenic stimulation of the vulvovaginal... (Review)
Review
Genitourinary syndrome of menopause (GSM) is a term used to define a compilation of signs and symptoms arising from decreased estrogenic stimulation of the vulvovaginal and lower urinary tract. Among 27-84% of women in postmenopausal are affected for symptoms of GSM, and these can unquestionably impair health, sexual function, consequently the quality of life of these women. The main signs and symptoms of GSM include, among others, burning, irritation, vulvovaginal dryness, dyspareunia, urinary symptoms of urgency, dysuria, or recurrent urinary tract infection. The diagnosis can be made through anamnesis, questionnaires, physical exams, and, sometimes, complementary exams. Objective vaginal assessment is essential and can be complemented by using the Vaginal Health Index (VHI), Vaginal Maturation Index (VMI), or vaginal pH measurement. The acknowledgment of this condition by health professionals is crucial for its identification and proper management and exclusion of other conditions that make a differential diagnosis with it.
PubMed: 36304000
DOI: 10.3389/frph.2021.779398