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Journal of Women's Health (2002) Mar 2018Vulvovaginal atrophy (VVA) is characterized by vaginal/vulvar dryness, irritation, dyspareunia, or dysuria. The objective of this study was to examine the efficacy and... (Randomized Controlled Trial)
Randomized Controlled Trial
A Randomized, Multicenter, Double-Blind, Study to Evaluate the Safety and Efficacy of Estradiol Vaginal Cream 0.003% in Postmenopausal Women with Vaginal Dryness as the Most Bothersome Symptom.
BACKGROUND
Vulvovaginal atrophy (VVA) is characterized by vaginal/vulvar dryness, irritation, dyspareunia, or dysuria. The objective of this study was to examine the efficacy and safety of a very low-dose estradiol vaginal cream (0.003%) applied twice per week in postmenopausal women with VVA-related vaginal dryness.
MATERIALS AND METHODS
In this phase 3, randomized, double-blind, placebo-controlled, multicenter study, postmenopausal women with moderate-severe vaginal dryness as the most bothersome VVA symptom were randomized (1:1) to estradiol cream 0.003% (15 μg estradiol; 0.5 g cream) or placebo (0.5 g cream). Treatments were applied vaginally once daily for 2 weeks followed by two applications/week for 10 weeks. Coprimary outcomes were changes in severity of vaginal dryness, percentage of vaginal superficial and parabasal cells, and vaginal pH at final assessment. Additional outcomes comprised changes in severity of other VVA signs and symptoms. Adverse events (AEs) were assessed.
RESULTS
Of the 576 randomized participants, most were white and had an average age of 59 years. At final assessment, estradiol reduced vaginal dryness severity, decreased vaginal pH, increased superficial cell percentage, and decreased parabasal cell percentage versus placebo (p ≤ 0.05, all). Estradiol also reduced vaginal dryness severity at Weeks 4-12 and dyspareunia at Week 8 versus placebo (p ≤ 0.05, all). Improvements in vaginal/vulvar irritation/itching severity and dysuria were similar between estradiol and placebo. Estradiol had comparable rates of treatment-emergent AEs to placebo. No deaths occurred.
CONCLUSIONS
Very low-dose estradiol vaginal cream (0.003%) dosed twice weekly is an effective and well-tolerated treatment for VVA symptoms and dryness associated with menopause.
Topics: Administration, Intravaginal; Atrophy; Double-Blind Method; Dyspareunia; Estradiol; Estrogens; Female; Humans; Hydrogen-Ion Concentration; Middle Aged; Postmenopause; Treatment Outcome; Vagina; Vaginal Creams, Foams, and Jellies; Vaginal Diseases; Vulva
PubMed: 29193980
DOI: 10.1089/jwh.2017.6515 -
Clinical Obstetrics and Gynecology Sep 2015Vulvovaginal atrophy is a common condition associated with decreased estrogenization of the vaginal tissue. Symptoms include vaginal dryness, irritation, itching,... (Review)
Review
Vulvovaginal atrophy is a common condition associated with decreased estrogenization of the vaginal tissue. Symptoms include vaginal dryness, irritation, itching, soreness, burning, dyspareunia, discharge, urinary frequency, and urgency. It can occur at any time in a woman's life cycle, although more commonly in the postmenopausal phase, during which the prevalence is approximately 50%. Despite the high prevalence and the substantial effect on quality of life, vulvovaginal atrophy often remains underreported and undertreated. This article aims to review the physiology, clinical presentation, assessment, and current recommendations for treatment, including aspects of effectiveness and safety of local vaginal estrogen therapies.
Topics: Administration, Cutaneous; Administration, Intravaginal; Aging; Atrophy; Estrogen Replacement Therapy; Female; Humans; Lubricants; Menopause; Vagina; Vaginal Diseases; Vulva; Vulvar Diseases
PubMed: 26125962
DOI: 10.1097/GRF.0000000000000126 -
Climacteric : the Journal of the... Aug 2023Local estrogen therapy (LET) is the mainstay of treatment for vaginal dryness, dyspareunia and other urogenital symptoms because it may reverse some pathophysiological... (Review)
Review
Local estrogen therapy (LET) is the mainstay of treatment for vaginal dryness, dyspareunia and other urogenital symptoms because it may reverse some pathophysiological mechanisms associated with decreasing endocrine function and increasing aging. Over the years, several vaginal products including different formulations (tablets, rings, capsules, pessaries, creams, gels and ovules) and molecules (estradiol [E2], estriol [E3], promestriene, conjugated equine estrogens and estrone) have been used with superimposable therapeutic results. Low-dose and ultra-low-dose LET is the gold standard due to its minimal systemic absorption, with circulating E2 levels persistently remaining in the postmenopausal range. In healthy postmenopausal women, preference among the various products is presently the main driver and dissatisfaction with LET seems high, namely because of the delayed use in those with severe symptoms of genitourinary syndrome of menopause (GSM). Specific concerns remain in high-risk populations such as breast cancer survivors (BCS), especially those under treatment with aromatase inhibitors. Based on the multitude of symptoms under the umbrella of GSM definition, which includes vulvovaginal atrophy (VVA), it is mandatory to investigate specific effects of LET on quality of life, sexual function and genitourinary conditions by conducting studies with a patient-tailored focus.
Topics: Humans; Female; Quality of Life; Estrogens; Vaginal Diseases; Dyspareunia; Hormone Replacement Therapy; Vagina; Atrophy; Menopause
PubMed: 37318030
DOI: 10.1080/13697137.2023.2218998 -
Menopause (New York, N.Y.) Jan 2020The primary aim was to evaluate changes in female sexuality across the menopausal period, and the secondary objective was to test the associations of female sexuality... (Observational Study)
Observational Study
OBJECTIVE
The primary aim was to evaluate changes in female sexuality across the menopausal period, and the secondary objective was to test the associations of female sexuality domains with vaginal atrophy and its symptoms.
METHODS
A cross-sectional multicenter study was performed involving 518 women, 40 to 55 years of age, consulting outpatient gynecological services at 30 centers across Italy. Vaginal atrophy was identified by the contemporaneous presence of a pH >5, subjective vaginal dryness, and an objective sign. The relationships between vaginal atrophy and its main symptoms (vaginal dryness and dyspareunia), and Female Sexual Function Index (FSFI) score and its domains (desire, arousal, orgasm, dyspareunia, lubrication, and sexual satisfaction) were analyzed.
RESULTS
The prevalence of sexual dysfunction, as defined by a FSFI score <26.55, was 70.6%, increasing from 55% in the years 40 to 45, to 82.8% (P < 0.01) in the years 52 to 55 of age. Mean FSFI score decreased from 40 to 45, to 46 to 48 years of age (23.13 ± 9.76 vs 19.49 ± 9.88; P < 0.05), and from 48 to 51, to 52 to 55 years of age (21.3 ± 8.06 to 17.59 ± 9.11; P < 0.01). Independent determinants of FSFI were age, vaginal atrophy, and the presence of vaginal dryness and dyspareunia (R2 0.208; P = 0.011). FSFI score was independently correlated (R2 0.116) with weight (CR -0.067; 95% confidence interval [CI] -0.126, -0.006; P < 0.032), menopausal status (CR -2.406; 95% CI -4.180, -0.63; P < 0.008), and vaginal dryness (CR -5.647; 95% CI -7.677, -3.618; P < 0.0001). Vaginal dryness was the only variable correlated independently with each FSFI domain, including desire (also correlated with menopausal status), arousal (with age and menopausal status), lubrication (with age), orgasm (with age), satisfaction (with vaginal atrophy and being an ex-smoker), and dyspareunia (with age and spontaneously referred dyspareunia).
CONCLUSIONS
In the perimenopausal years, FSFI score decreases and sexual dysfunction increases by about 30%. Vaginal dryness is the symptom of vaginal atrophy most closely related to all domains of female sexuality.
Topics: Adult; Atrophy; Cross-Sectional Studies; Dyspareunia; Female; Humans; Italy; Menopause; Middle Aged; Orgasm; Prevalence; Sexual Dysfunction, Physiological; Sexuality; Vagina; Vaginal Diseases
PubMed: 31738734
DOI: 10.1097/GME.0000000000001427 -
Vaginal estrogen therapy in postmenopausal breast cancer patients treated with aromatase inhibitors.Archives of Gynecology and Obstetrics May 2012Breast cancer is the most frequent cancer among women with about 1.38 million new cases worldwide every year. Most of these patients are postmenopausal and suffer from... (Review)
Review
INTRODUCTION
Breast cancer is the most frequent cancer among women with about 1.38 million new cases worldwide every year. Most of these patients are postmenopausal and suffer from hormone receptor positive breast tumors. About 50% of postmenopausal women between 50 and 60 years and 72% of women over 70 years suffer from vulvovaginal athrophy (VVA). Adjuvant treatment with aromatase inhibitors (AIs) improves outcomes in postmenopausal women with hormone receptor positive early stage breast cancer compared with tamoxifen. A frequent side effect of AI use is VVA with symptoms like vaginal dryness, vaginitis, pruritus, dyspareunia and cystitis.
MATERIALS AND METHODS
We searched major databases (i.e. pubmed) with the following selection criteria: breast cancer, hormone therapy, vaginal estrogen, aromatase inhibitor, vaginal atrophy, serum estrogen levels.
CONCLUSIONS
Vaginal administration of estradiol is a well known and safe alternative to systemic estrogen therapy, but studies demonstrated significant increases in plasma concentrations of estradiol. Such observations have also been reported in postmenopausal breast cancer patients treated with AIs. Further studies are needed to explore risk of breast cancer recurrence after vaginal estrogen application for patients on adjuvant endocrine therapy with AIs.
Topics: Administration, Intravaginal; Aromatase Inhibitors; Breast Neoplasms; Estradiol; Estrogen Replacement Therapy; Estrogens; Female; Humans; Vaginal Diseases
PubMed: 22212649
DOI: 10.1007/s00404-011-2181-6 -
Climacteric : the Journal of the... Dec 2019The joint burden of cancer and menopause impacts millions of women globally. This review provides an approach to management of menopausal symptoms after cancer in all... (Review)
Review
The joint burden of cancer and menopause impacts millions of women globally. This review provides an approach to management of menopausal symptoms after cancer in all settings. This includes an overview of current evidence for both hormonal and non-hormonal treatments for vasomotor symptoms and vaginal dryness after cancer. Systemic menopausal hormone therapy provides symptom control and may be used after most cancers but should be avoided after estrogen receptor-positive breast cancer and after some other estrogen-dependent cancers. Non-hormonal therapies have been minimally studied in women after a cancer diagnosis and, where they have been studied, it is usually in women with breast cancer. Non-hormonal methods to manage vasomotor symptoms include cognitive behavioral therapy, hypnosis, selective serotonin reuptake inhibitors, serotonin noradrenaline reuptake inhibitors, clonidine, and gabapentin. Vaginal estrogen may be useful to address vaginal dryness. However, safety data in breast cancer patients are still lacking and there is currently no consensus. Lubricants may also help with pain with sexual activity. Management of menopausal symptoms after cancer may be challenging and should include information about induced menopause and possible symptoms as well as available treatments. Management then requires a holistic and multidisciplinary approach with individualized care.
Topics: Cancer Survivors; Female; Hot Flashes; Humans; Menopause
PubMed: 31433675
DOI: 10.1080/13697137.2019.1646718 -
Maturitas May 2003To objectively analyze vaginal dryness in postmenopausal women. (Comparative Study)
Comparative Study
OBJECTIVE
To objectively analyze vaginal dryness in postmenopausal women.
METHODS
Forty healthy postmenopausal women, were divided in three groups according to the treatment they received. Group I, conjugated equine estrogens (CEE) 0.625 mg/day (n=20), group II, CEE 0.625 mg/day plus chlormadinone 1 mg/day (n=13), and group III, CEE 0.625 mg/day plus medroxyprogesterone 2.5 mg/day (n=7). Vaginal dryness intensity was analyzed using an analog visual scale, and vaginal humidity measuring the moistening in mm of a pH test strip. Both were evaluated at baseline and 3 months after the beginning of treatment. The comparison among groups and between the baseline and final results was done with Student's t-test for paired and independent samples, respectively. Pearson correlation analysis was carried out between final vaginal dryness intensity and the final moistening of the pH test strip.
RESULTS
No statistically significant differences were found in age neither in somatometric variables among the groups. In the three groups, vaginal dryness intensity significantly decreased and the pH test strip moistening significantly increased. A significant negative correlation was only found in group II (-0.690 P<0.009).
CONCLUSIONS
Vaginal dryness evaluation assessing the pH test strip moistening is an objective method to evaluate this symptom in postmenopausal women, and the results are independent of the hormone replacement therapy schedule.
Topics: Atrophy; Chlormadinone Acetate; Drug Administration Schedule; Estrogen Replacement Therapy; Estrogens, Conjugated (USP); Female; Humans; Hydrogen-Ion Concentration; Medroxyprogesterone; Middle Aged; Pain Measurement; Postmenopause; Predictive Value of Tests; Vagina; Vaginal Diseases
PubMed: 12753944
DOI: 10.1016/s0378-5122(03)00082-3 -
Climacteric : the Journal of the... 2015The major cause of urogenital atrophy in menopausal women is estrogen loss. The symptoms are usually progressive in nature and deteriorate with time from the menopausal... (Review)
Review
The major cause of urogenital atrophy in menopausal women is estrogen loss. The symptoms are usually progressive in nature and deteriorate with time from the menopausal transition. The most prevalent urogenital symptoms are vaginal dryness, vaginal irritation and itching. The genitourinary syndrome of menopause includes vulvovaginal atrophy and the postmenopausal modifications of the lower urinary tract. Dyspareunia and vaginal bleeding from fragile atrophic skin are common problems. Other urogenital complaints include frequency, nocturia, urgency, stress urinary incontinence and urinary tract infections. Atrophic changes of the vulva, vagina and lower urinary tract can have a large impact on the quality of life of the menopausal woman. However, hormonal and non-hormonal treatments can provide patients with the solution to regain the previous level of function. Therefore, clinicians should sensitively question and examine menopausal women, in order to correctly identify the pattern of changes in urogenital atrophy and manage them appropriately.
Topics: Atrophy; Dyspareunia; Estrogen Replacement Therapy; Estrogens; Female; Female Urogenital Diseases; Gynecology; Humans; Menopause; Pelvic Floor; Pelvic Organ Prolapse; Postmenopause; Quality of Life; Urinary Incontinence, Stress; Urinary Tract Infections; Urogenital System; Vagina; Vaginal Diseases; Vulva
PubMed: 26366796
DOI: 10.3109/13697137.2015.1078206 -
Gynecological Endocrinology : the... Mar 2024Vaginal dryness (VD) represents a significant concern affecting women across diverse life stages, encompassing both pre- and postmenopausal women at any age....
Prospective, multicenter, uncontrolled study on the effectiveness and safety of a hyaluronic acid water-based vaginal lubricant in alleviating vaginal dryness and dyspareunia.
BACKGROUND
Vaginal dryness (VD) represents a significant concern affecting women across diverse life stages, encompassing both pre- and postmenopausal women at any age. Dyspareunia, defined by genital pain that can be experienced before, during, or after intercourse, is often associated with vaginal dryness.
AIM
This study aimed to evaluate the effectiveness and safety of a water-based vaginal lubricant with hyaluronic acid to reduce sexual discomfort associated with vaginal dryness.
METHODS
A prospective, multicenter, uncontrolled clinical investigation was conducted over a three-month period in women aged 18 years or older experiencing pain or difficulty during sexual intercourse for whom the use of a vaginal lubricant was recommended.
RESULTS
Significant improvements were observed in the FSFI scores, indicating enhanced sexual function ( < .001). Vaginal dryness symptoms, including irritation, dryness, itching, and dyspareunia, significantly decreased after product use ( < .001).
CLINICAL IMPLICATIONS
This study contributes to the limited scientific knowledge on the application of lubricants in the context of symptoms associated with VD.
STRENGTHS & LIMITATIONS
In addition to the short study period, inherent limitations of the study design, and lack of placebo control, it is pertinent to acknowledge that some of the pros used in this study were not based on validated questionnaires. However, as far as we know, this study is the only one that analyzes well-being and sexual pleasure as results using a lubricant formulated with hyaluronic acid.
CONCLUSION
This tested vaginal lubricant with hyaluronic acid has demonstrated efficacy in improving vaginal dryness and female sexual function, particularly in reducing pain and improving lubrication during sexual intercourse, and showed a favorable safety profile, with minimal and transient adverse events.
Topics: Female; Humans; Atrophy; Dyspareunia; Hyaluronic Acid; Lubricants; Pain; Prospective Studies; Vagina; Vaginal Diseases; Water
PubMed: 38468593
DOI: 10.1080/09513590.2024.2317268 -
Mayo Clinic Proceedings Jan 2010Vulvovaginal atrophy (VVA) is a common and underreported condition associated with decreased estrogenization of the vaginal tissue. Symptoms include dryness, irritation,... (Review)
Review
Vulvovaginal atrophy (VVA) is a common and underreported condition associated with decreased estrogenization of the vaginal tissue. Symptoms include dryness, irritation, soreness, and dyspareunia with urinary frequency, urgency, and urge incontinence. It can occur at any time in a woman's life cycle, although more commonly in the postmenopausal phase, during which the prevalence is close to 50%. Clinical findings include the presence of pale and dry vulvovaginal mucosa with petechiae. Vaginal rugae disappear, and the cervix may become flush with the vaginal wall. A vaginal pH of 4.6 or more supports the diagnosis of VVA. Even while taking systemic estrogen, 10% to 20% of women may still have residual VVA symptoms. Breast cancer treatment increases the prevalence of VVA because the surgical, endocrine, and chemotherapeutic agents used in its treatment can cause or exacerbate VVA. Local estrogen treatment for this group of women remains controversial.
Topics: Administration, Intravaginal; Diagnosis, Differential; Estrogen Replacement Therapy; Female; Humans; Menopause; Middle Aged; Vaginal Diseases; Vaginitis; Vulvar Diseases
PubMed: 20042564
DOI: 10.4065/mcp.2009.0413