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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 -
European Journal of Obstetrics,... Jun 2023Vaginal atrophy is a condition where the vaginal epithelium gets thinner and includes symptoms, such as vaginal dryness, abnormal vaginal discharge, vaginal bleeding,... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND AND OBJECTIVE
Vaginal atrophy is a condition where the vaginal epithelium gets thinner and includes symptoms, such as vaginal dryness, abnormal vaginal discharge, vaginal bleeding, dyspareunia, and sexual problems. Hormone therapy is associated with some problems and some women prefer herbal medicine to reduce vaginal atrophy. Considering the phytoestrogenic compounds present in the nettle, this study aimed to investigate the effect of the nettle vaginal cream on subjective symptoms of vaginal atrophy in postmenopausal women.
MATERIALS AND METHODS
This triple-blind randomized placebo-controlled clinical trial study was conducted on 84 eligible postmenopausal women aged 45-60 years, who referred to comprehensive health service centers in Aliabad Katul in 2021-2022. Women eligible for the study received 5% nettle vaginal cream and placebo for 8 weeks. Subjective symptoms of vaginal atrophy were assessed before, four and eight weeks after the intervention. Data collection tools included a checklist for research unit selection, individual and midwifery characteristics questionnaire, vaginal assessment scale (VAS), vaginal pH, laboratory results of the vaginal maturation value (VMV). Data analysis was performed using SPSS software (version 21) and independent t-test, Mann-Whitney, chi-square, Two-way analysis of variance and analysis of covariance. P value less than 0.05 was considered significant.
RESULTS
Subjective symptoms of vaginal atrophy decreased significantly after the intervention compared to before the intervention in both the nettle and placebo groups (p < 0.001), but in the comparison between groups four weeks and eight weeks after the intervention, the subjective symptoms of vaginal atrophy in nettle group decreased significantly (p < 0.001). In the nettle group, the scores of vaginal burning, vaginal dryness, vaginal itching and dyspareunia significantly improved after the intervention compared to before the intervention (p < 0.001). Also, in the nettle group compared to the placebo group, after the intervention, vaginal burning and vaginal dryness score (p < 0.001) and vaginal itching score (0.004) improved significantly.
CONCLUSION
Based on the results of the present study, Nettle vaginal cream reduced subjective symptoms of vaginal atrophy, including vaginal burning, vaginal dryness, vaginal itching, and dyspareunia in postmenopausal women, so it is a cost-effective, available and do not have the side effects product that can be useful for menopausal women.
Topics: Female; Humans; Vaginal Creams, Foams, and Jellies; Postmenopause; Dyspareunia; Administration, Intravaginal; Vaginal Diseases; Vagina; Atrophy; Pruritus; Treatment Outcome
PubMed: 37044017
DOI: 10.1016/j.ejogrb.2023.03.037 -
Clinics in Dermatology 2018Vulvovaginal conditions are common in mature women. This reflects age-related changes in immunity and skin barrier function of vulvovaginal tissues. Vaginal atrophy is... (Review)
Review
Vulvovaginal conditions are common in mature women. This reflects age-related changes in immunity and skin barrier function of vulvovaginal tissues. Vaginal atrophy is commonly complicated by dryness and inflammation, which makes postmenopausal atrophic vaginitis a virtually ubiquitous condition. The differential of vaginitis includes inflammatory, infectious, and malignant diseases, plus drug hypersensitivity. Atrophic vaginitis is treated with estrogen replacement therapy. Vulvovaginal malignant melanoma occurs predominantly in postmenopausal women and carries a poor prognosis. Similarly, the incidence of vulvovaginal malignancies, such as squamous cell carcinoma and extramammary Paget disease, rises exponentially after 65 years of age. Early diagnosis of these malignancies is of utmost importance. Lichen sclerosus et atrophicus and vulvovaginal candidosis are among the most common postmenopausal vulvovaginal conditions. Lichen sclerosus et atrophicus is associated with significant morbidity, and its management can be challenging. The incidence of vulvovaginal candidosis increases in patients on estrogen replacement therapy.
Topics: Aging; Carcinoma, Squamous Cell; Female; Genital Diseases, Female; Humans; Melanoma; Paget Disease, Extramammary; Postmenopause; Skin Diseases; Vagina; Vaginal Neoplasms; Vaginitis; Vulva; Vulvar Neoplasms
PubMed: 29566925
DOI: 10.1016/j.clindermatol.2017.10.012 -
The Cochrane Database of Systematic... Mar 2010The delivery of combination contraceptive steroids from a skin patch or vaginal ring offers potential advantages over the traditional oral route. The skin patch and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The delivery of combination contraceptive steroids from a skin patch or vaginal ring offers potential advantages over the traditional oral route. The skin patch and vaginal ring could require a lower dose due to increased bioavailability and improved user compliance.
OBJECTIVES
To compare the contraceptive effectiveness, cycle control, adherence (compliance), and safety of the skin patch or the vaginal ring versus combination oral contraceptives (COCs).
SEARCH STRATEGY
For trials of the contraceptive patch or the vaginal ring, we searched MEDLINE, POPLINE, CENTRAL, EMBASE, LILACS, ClinicalTrials.gov, and ICTRP. We contacted manufacturers and researchers to identify other trials.
SELECTION CRITERIA
All randomized controlled trials comparing the skin patch or vaginal ring with a COC.
DATA COLLECTION AND ANALYSIS
Data were abstracted by two authors and entered into RevMan. For dichotomous variables, the Peto odds ratio (OR) with 95% confidence intervals (CI) was calculated. For continuous variables, the mean difference was computed.
MAIN RESULTS
We found 5 trials of the skin patch and 10 of the vaginal ring. Contraceptive effectiveness was similar for the patch or ring versus the comparison COC. More patch users discontinued early than COC users: ORs were 1.59 (95% CI 1.26 to 2.00), 1.56 (95% CI 1.18 to 2.06), and 2.57 (95% CI 0.99 to 6.64). Patch users also had more discontinuation due to adverse events. Compared to COC users, patch users reported more breast discomfort, dysmenorrhea, nausea, and vomiting. Patch users reported more compliant cycles than the COC users in two trials: ORs were 2.05 (95% CI 1.83 to 2.29) and 2.76 (95% CI 2.35 to 3.24). The ring trials generally showed similar discontinuation for ring and COC users. Ring users reported less nausea, acne, irritability, and depression than COC users. Ring users had more vaginitis and leukorrhea but less vaginal dryness. Ring users had similar adherence to COC users in two trials but less adherence in one. Cycle control was generally similar for the patch and COC, and was similar or better for the ring versus COC.
AUTHORS' CONCLUSIONS
Effectiveness was similar for the methods compared. The patch could lead to more discontinuation while the vaginal ring showed little difference. The patch group had better compliance than the COC group but more side effects. Ring users generally had fewer adverse events than COC users but more vaginal irritation and discharge. High losses to follow up can affect the validity of the results.
Topics: Consumer Behavior; Contraceptive Agents, Female; Contraceptive Devices, Female; Contraceptives, Oral, Combined; Drug Implants; Female; Humans; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 20238323
DOI: 10.1002/14651858.CD003552.pub3 -
Menopause (New York, N.Y.) Jul 2018The aim of the study was to determine the utility of vaginal pH as a marker of menopause and vulvar and vaginal atrophy (VVA) before and after local estrogen treatment. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
The aim of the study was to determine the utility of vaginal pH as a marker of menopause and vulvar and vaginal atrophy (VVA) before and after local estrogen treatment.
METHODS
Vaginal pH was determined using standard pH paper strips in two clinical trials involving postmenopausal women with signs and symptoms of VVA evaluated before and after intervention with vaginal estradiol in softgel capsules. The utility of vaginal pH was evaluated as a screening method for VVA due to menopause and correlations were analyzed between vaginal pH and VVA symptoms, physical changes, and maturation of the vaginal epithelium.
RESULTS
Changes in vaginal pH were significantly correlated with changes in superficial and parabasal cell counts; vaginal epithelial changes of color, integrity, thickness, and secretion; and the VVA symptoms of vaginal dryness and dyspareunia (vaginal pain with intercourse).
CONCLUSIONS
Vaginal pH consistently correlated with parabasal and superficial cells and the visual vaginal epithelial changes and symptoms of dryness and dyspareunia, and is thus a simple outpatient procedure that reflects the hormonal milieu and its effects on the vaginal epithelium.
Topics: Administration, Intravaginal; Adult; Aged; Atrophy; Double-Blind Method; Dyspareunia; Estradiol; Estrogens; Female; Humans; Hydrogen-Ion Concentration; Middle Aged; Outcome Assessment, Health Care; Postmenopause; Treatment Outcome; Vagina; Vaginal Diseases
PubMed: 29509598
DOI: 10.1097/GME.0000000000001081 -
Surgical Technology International May 2019Vulvo-vaginal atrophy as a main symptom of the Genito Urinary Syndrome of Menopause (GSM) is a consequence of aging, particularly after menopause as a result of...
Vulvo-vaginal atrophy as a main symptom of the Genito Urinary Syndrome of Menopause (GSM) is a consequence of aging, particularly after menopause as a result of follicular ovarian follicle depletion and consequently low estrogen levels. Anatomical structures derived from the urogenital sinus, such as the distal urethra trigone and vestibule, are the most affected areas because of the high concentrations of alfa- and beta-estrogen receptors. The most common symptoms associated with vulvo-vaginal atrophy are dyspareunia, vaginal dryness, irritation, recurrent urinary tract infection and urinary incontinence, which negatively affect the patient's quality of life and sexuality. The purpose of this pilot study was to evaluate a protocol with topical growth factors that seeks to activate collagen and elastin at a molecular level, and thus restore all vaginal functions such as secretion, absorption, elasticity, lubrication and vaginal epithelium thickness.
Topics: Administration, Topical; Atrophy; Dyspareunia; Female; Genitalia, Female; Humans; Intercellular Signaling Peptides and Proteins; Menopause; Pilot Projects; Quality of Life; Vagina; Vaginal Diseases; Vulva
PubMed: 30388724
DOI: No ID Found -
European Journal of Obstetrics,... Mar 2019Evaluate the efficacy and safety of a non-hormonal intravaginal moisturizer on reducing the symptoms arising from vaginal dryness and sexual dysfunction.
OBJECTIVE
Evaluate the efficacy and safety of a non-hormonal intravaginal moisturizer on reducing the symptoms arising from vaginal dryness and sexual dysfunction.
STUDY DESIGN
A total of 37 postmenopausal women used a non-hormonal intravaginal Moisturizer (polycarbophil, butyl ester of a copolymer of methyl vinyl ether/ copolymer PVM/MA, 50% sodium lactate solution, and Carbopol) twice a week for 12 weeks. The vaginal moisture levels, volume of fluid, elasticity, and epithelium integrity were assessed using the Vaginal Health Index. Sexual function was measured using the Female Sexual Function Index questionnaire. All women were evaluated before starting treatment and at the 4th, 8th and 12th weeks of the study. At the end of the study, the patients analysed the treatment regarding to their satisfaction with the product, and its application system, their sense of well-being after using it as well as their perception bout the discharge of the moisturizer (if it run or was held by the vaginal mucosa).
RESULTS
There was a significant improvement in the vaginal moisture, fluid volume, elasticity and epithelial integrity (p < 0.001). Sexual function improved in the total score and in all six domains (p < 0.001). More than 50% of all patients reported being very satisfied with the treatment and product application. The sense of well-being was considered very good by 51.4% of the participants and most (91.9%) indicated that the product did not leak and did not stick to the vaginal mucosa. No severe adverse events were reported.
CONCLUSION
Our study suggests that treatment with the non-hormonal intravaginal moisturizer is a safe and efficient therapeutic option for the improvement of vaginal dryness with encouraging benefits for the sexual function of postmenopausal women.
Topics: Administration, Intravaginal; Aged; Dyspareunia; Female; Humans; Lubricants; Middle Aged; Patient Satisfaction; Postmenopause; Prospective Studies; Vagina; Vaginal Creams, Foams, and Jellies; Vaginal Diseases
PubMed: 30677618
DOI: 10.1016/j.ejogrb.2018.12.040 -
BMC Cancer Nov 2023Vaginal CO laser therapy is a new treatment option for genitourinary syndrome of menopause. Its potential is particularly interesting in breast cancer survivors, where...
BACKGROUND
Vaginal CO laser therapy is a new treatment option for genitourinary syndrome of menopause. Its potential is particularly interesting in breast cancer survivors, where existing treatment options often are insufficient as hormonal treatment is problematic in these women. The objective of this study is to investigate the effectiveness of vaginal laser treatment for alleviation of genitourinary syndrome of menopause in breast cancer survivors treated with adjuvant endocrine therapy. The secondary objective is to explore the importance of repeated vaginal laser treatment and the long-term effects in this patient population.
METHODS
VagLaser consist of three sub-studies; a dose response study, a randomized, participant blinded, placebo-controlled study and a follow-up study. All studies include breast cancer survivors in adjuvant endocrine therapy, and are conducted at the Department of Obstetrics and Gynecology, Randers Regional Hospital, Denmark. The first participant was recruited on 16th of February 2023. Primary outcome is vaginal dryness. Secondary subjective outcomes are vaginal pain, itching, soreness, urinary symptoms and sexual function. Secondary objective outcomes are change in vaginal histology (punch biopsy), change in vaginal and urine microbiota, and change in vaginal pH.
DISCUSSION
More randomized controlled trials, with longer follow-up to explore the optimal treatment regimen and the number of repeat vaginal laser treatments for alleviation the symptoms of genitourinary syndrome of menopause in breast cancer survivors treated with endocrine adjuvant therapy, are needed. This study will be the first to investigate change in vaginal and urine microbiota during vaginal laser therapy in breast cancer survivors.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT06007027 (registered 22 August, 2023).
PROTOCOL VERSION
Version 1, Date 13.11.2023.
Topics: Humans; Female; Breast Neoplasms; Cancer Survivors; Carbon Dioxide; Follow-Up Studies; Laser Therapy; Female Urogenital Diseases; Menopause; Vagina; Urogenital Neoplasms; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 38031020
DOI: 10.1186/s12885-023-11656-x -
Nursing For Women's Health Dec 2012During the menopausal transition and after menopause, up to 45 percent of women will develop vaginal atrophy as a consequence of decreased levels of circulating... (Review)
Review
During the menopausal transition and after menopause, up to 45 percent of women will develop vaginal atrophy as a consequence of decreased levels of circulating estrogen. Symptoms include vaginal dryness, itching, soreness, bleeding, increased susceptibility to infection and pain with sexual intercourse. Treatments are often underused because of patient and clinician lack of knowledge of available treatments, embarrassment about initiating a discussion of symptoms and reluctance to initiate hormonal therapy. Methods of symptom management include self-care with over-the-counter agents and prescription treatment with various forms of localized estrogen. Clinicians should consider each woman's unique situation and health history before recommending a management strategy.
Topics: Atrophy; Chronic Disease; Dyspareunia; Estrogen Replacement Therapy; Female; Humans; Menopause; Quality of Life; Vagina; Vaginal Creams, Foams, and Jellies; Vaginal Diseases; Vulvar Diseases
PubMed: 23253575
DOI: 10.1111/j.1751-486X.2012.01776.x -
European Journal of Obstetrics,... Aug 2016To prove the efficacy, tolerability and safety of Monurelle Biogel(®) (ZP-025) vaginal gel, which contains a purified, dialyzed, lyophilized bovine colostrum, in women... (Randomized Controlled Trial)
Randomized Controlled Trial
Efficacy, tolerability and safety of a new medical device, Monurelle Biogel(®) vaginal gel, in the treatment of vaginal dryness: a randomized clinical trial in women of reproductive age.
OBJECTIVE
To prove the efficacy, tolerability and safety of Monurelle Biogel(®) (ZP-025) vaginal gel, which contains a purified, dialyzed, lyophilized bovine colostrum, in women of reproductive age suffering from vaginal dryness.
DESIGN
Randomized clinical trial (RCT) (Z7213M01).
SETTING
Five University Gynaecological Units.
PATIENTS
Ninety-five subjects were allocated at random to receive either ZP-025 (n=48) for about 23 intermenstrual days (1 or 2 times/daily intra-vaginally) or no treatment (lubricants on demand were allowed).
MAIN OUTCOME MEASURES
Change of Verbal Rating Scale (VRS) total and single score for vaginal symptoms, Vaginal Health Index (VHI) score, Female Sexual Function index (FSFI) and Female Sexual Distress Scale-revised (FSDS-R) scores.
RESULTS
A total number of 85 subjects was evaluable for primary analyses. Symptoms (VRS) of vaginal discomfort improved significantly already after 11 days, as compared to the control arm (p<0.0001). The mean VHI score was also significantly higher in ZP-025 group (p<0.001) at the end of the study. The analysis of covariance with the baseline value as covariate carried out on the FSFI Total Score showed a statistically significant difference in favour of the ZP-025 arm (p<0.032). A shift from presence to absence of sexual distress (≤11 points) was more prominent in the ZP-025 arm [10 subjects (40%) in the ZP-025 arm (p<0.0001) and 6 subjects (21.4%) in the control arm (p=0.01)]. Women reported a compliance rate of 100% for one ZP-025 application/day. Local tolerability of ZP-025 was excellent or good in 82.9% of the subjects.
CONCLUSIONS
The present multicentre RCT supports the use of Monurelle Biogel(®) in women of reproductive age reporting symptoms of vaginal dryness. A positive impact on vaginal health and sexual function was also evident.
Topics: Administration, Intravaginal; Adult; Colostrum; Female; Humans; Libido; Middle Aged; Sexual Behavior; Treatment Outcome; Vaginal Creams, Foams, and Jellies; Vaginal Diseases; Young Adult
PubMed: 27261817
DOI: 10.1016/j.ejogrb.2016.05.005