Dataset Information

Safety and Efficacy of an Oxytocin Gel and an Equivalent Gel but Without Hormonal Ingredients (Vagivital® Gel) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy: A Randomized, Double-Blind Controlled Study.

ABSTRACT: Purpose:The primary objective was to compare the efficacy of 12 weeks of daily treatment with Aqueous Hypromellose-based vaginal (Vagivital®) gel versus Aqueous Hypromellose-based vaginal gel plus 400 IU oxytocin gel in reducing the severity of the most bothersome vulvovaginal atrophy symptoms (MBS: itching, dysuria, bleeding, and pain/discomfort during vaginal sexual activity) observed at baseline. The secondary objectives were to evaluate the other vulvovaginal atrophy symptoms, vaginal pH, superficial squamous cells, and the safety and tolerability of both gels. Patients and Methods:This double-blind, randomized study evaluated the safety and efficacy of subjects randomly assigned to 12 weeks of daily intravaginal oxytocin gel (n=79) or Aqueous Hypromellose-based vaginal gel (n=78). The efficacy evaluation was performed using data from all included subjects who fulfilled entry criteria. Results:Both treatments induced statistically significant reductions in the severity of the MBS from baseline until 4 weeks (Vagivital mean reduction 0.90, p=0.0000; Oxytocin mean reduction 0.82, p=0.0000) and 12 weeks post baseline (Vagivital mean reduction 1.28, p=0.0000; Oxytocin mean reduction 1.16, p=0.0000), but the reduction of MBS severity was not significantly different between the treatment groups at either time point. No serious adverse events were reported in the Aqueous Hypromellose-based vaginal gel group during the treatment period, but one (breast cancer) was reported in the oxytocin gel group (assessed as unlikely related to the study compound). Conclusion:Significant reductions in the severity of the MBS were seen in both the Aqueous Hypromellose-based vaginal gel and the oxytocin gel groups, but with no significant differences in severity reduction seen between the groups. Both gels were safe and well tolerated. Given the benefits of avoiding the use of hormones, Aqueous Hypromellose-based vaginal gel is an attractive first choice in the treatment of postmenopausal women with vulvovaginal atrophy symptoms.

SUBMITTER: Fianu Jonasson A

PROVIDER: S-EPMC7547122 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Safety and Efficacy of an Oxytocin Gel and an Equivalent Gel but Without Hormonal Ingredients (Vagivital<sup>®</sup> Gel) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy: A Randomized, Double-Blind Controlled Study.

Fianu Jonasson Aino A Bixo Marie M Sundström Poromaa Inger I Åstrom Mikael M Åstrom Mikael M

Medical devices (Auckland, N.Z.) 20201005

<h4>Purpose</h4>The primary objective was to compare the efficacy of 12 weeks of daily treatment with Aqueous Hypromellose-based vaginal (Vagivital<sup>®</sup>) gel versus Aqueous Hypromellose-based vaginal gel plus 400 IU oxytocin gel in reducing the severity of the most bothersome vulvovaginal atrophy symptoms (MBS: itching, dysuria, bleeding, and pain/discomfort during vaginal sexual activity) observed at baseline. The secondary objectives were to evaluate the other vulvovaginal atrophy sympt ...[more]

PMID: 33116956

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Project description:BackgroundGenitourinary syndrome of menopause (GSM) is a common and disturbing issue in the postmenopausal period. Unlike vasomotor symptoms, it has a progressive trend. Our study aims to evaluate the efficacy and safety of oxytocin gel versus placebo gel in postmenopausal women with GSM.MethodsA systematic review and meta-analysis synthesizing randomized controlled trials (RCTs) from Web of Science, SCOPUS, PubMed, and Cochrane Central Register of Controlled Trials databases on January 18, 2023. Keywords such as "oxytocin," "intravaginal," "vaginal," "atrophic," and "atrophy" were used. We used Review Manager (RevMan) version 5.4 in our analysis. We used the risk ratio (RR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes; both were presented with the corresponding 95% confidence interval (CI) and were calculated with the Mantel-Haenszel or inverse variance statistical method. Cochrane's Q test and the I2 statistic were used as measures of statistical inconsistency and heterogeneity. The Cochrane Risk of Bias Tool for RCTs was used for the quality assessment of the included studies.ResultsSeven studies with 631 patients were included. Regarding the maturation index, there was a statistically insignificant increase in the oxytocin arm (MD = 12.34, 95% CI (-12.52-37.19), P = 0.33). Clinically assessed vaginal atrophy showed a statistically significant reduction in the oxytocin group (RR = 0.32, 95% CI (0.23 - 0.10), P < 0.00001). For dyspareunia, vaginal pH, and histological evaluation of vaginal atrophy, there was a statistically insignificant difference between the two groups (RR = 1.02, 95% CI (0.82-1.27), P = 0.84), (MD = -0.74, 95% CI (-1.58-0.10), P = 0.08), and (MD = -0.38, 95% CI (-0.82-0.06), P = 0.09), respectively. There was no significant difference in the safety profile between the two groups as measured by endometrial thickness (MD = 0.00, 95% CI (-0.23-0.23), P = 0.99).ConclusionsAlthough oxytocin has been proposed as a viable alternative to estrogen in the treatment of GSM, our findings show the opposite. Larger, high-quality RCTs are needed to confirm or refute our results.Trial registrationPROSPERO registration number CRD42022334357.

Project description:Objective To evaluate the efficacy of the hormonal and nonhormonal approaches to symptoms of sexual dysfunction and vaginal atrophy in postmenopausal women.Data sources We conducted a search on the PubMed, Embase, Scopus, Web of Science, SciELO, the Cochrane Central Register of Controlled Trials (CENTRAL), and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases, as well as on clinical trial databases. We analyzed studies published between 1996 and May 30, 2020. No language restrictions were applied.Selection of studies We selected randomized clinical trials that evaluated the treatment of sexual dysfunction in postmenopausal women.Data collection Three authors (ACAS, APFC, and JL) reviewed each article based on its title and abstract. Relevant data were subsequently taken from the full-text article. Any discrepancies during the review were resolved by consensus between all the listed authors.Data synthesis A total of 55 studies were included in the systematic review. The approaches tested to treat sexual dysfunction were as follows: lubricants and moisturizers (18 studies); phytoestrogens (14 studies); dehydroepiandrosterone (DHEA; 8 studies); ospemifene (5 studies); vaginal testosterone (4 studies); pelvic ﬂoor muscle exercises (2 studies); oxytocin (2 studies); vaginal CO2 laser (2 studies); lidocaine (1 study); and vitamin E vaginal suppository (1 study).Conclusion We identified literature that lacks coherence in terms of the proposed treatments and selected outcome measures. Despite the great diversity in treatment modalities and outcome measures, the present systematic review can shed light on potential targets for the treatment, which is deemed necessary for sexual dysfunction, assuming that most randomized trials were evaluated with a low risk of bias according to the Cochrane Collaboration risk of bias tool. The present review is registered with the International Prospective Register of Systematic Reviews (PROSPERO; CRD42018100488).

Project description:The vaginal microbiota helps protect the female genital tract from disease. We sought to describe the composition of the vaginal microbiota in premenopausal, perimenopausal, and postmenopausal women and to explore the association between the microbiota and vulvovaginal atrophy (VVA).Eighty-seven women (aged 35-60 y) were classified as premenopausal (n = 30), perimenopausal (n = 29), or postmenopausal (n = 28) according to Stages of Reproductive Aging Workshop guidelines. Midvaginal bacterial community composition was characterized by 16S ribosomal RNA gene analysis.Bacterial communities clustered into six community state types (CSTs), of which four were dominated by Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus iners, or Lactobacillus jensenii, and two (CST IV-A and CST IV-B) had low relative abundance of Lactobacillus. CST IV-A was characterized by Streptococcus and Prevotella, whereas CST IV-B was characterized by Atopobium. There were significant associations between menopause stage and CST (P = 0.004) and between VVA and CST (P = 0.002). Perimenopausal women were more likely to be classified as CST IV-A or L. gasseri CST, whereas postmenopausal women were often classified as CST IV-A. CSTs dominated by L. crispatus and L. iners were more prevalent in premenopausal women. Nineteen participants had signs of mild or moderate VVA. Compared with women with no VVA, the vaginal microbiota of women with mild or moderate atrophy had 25-fold greater odds of being classified as CST IV-A versus L. crispatus CST (adjusted odds ratio, 25.89; 95% credible interval, 2.98-406.79).A distinct bacterial community state (CST IV-A) with a low relative abundance of Lactobacillus is associated with VVA. Future studies recruiting a larger number of women are needed to replicate the findings. This study provides an impetus for future longitudinal studies designed to manage, modulate, and restore vaginal microbiota homeostasis, which would provide stronger evidence for a causal relationship with VVA and ultimately improve the treatment and prevention of atrophic vaginitis in menopause.

Dataset Information

Safety and Efficacy of an Oxytocin Gel and an Equivalent Gel but Without Hormonal Ingredients (Vagivital® Gel) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy: A Randomized, Double-Blind Controlled Study.

Publications

Safety and Efficacy of an Oxytocin Gel and an Equivalent Gel but Without Hormonal Ingredients (Vagivital<sup>®</sup> Gel) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy: A Randomized, Double-Blind Controlled Study.

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