Replens versus dienoestrol cream in the symptomatic treatment of vaginal atrophy in postmenopausal women
Abstract
Objectives: This study was designed to evaluate the efficacy of Replens, a non-hormonal moisturizing vaginal gel, on symptoms of vaginal atrophy in postmenopausal women, in comparison with Dienoestrol (Cilag), an oestrogenic vaginal cream. Methods: Thirty-nine patients were randomly allocated to either of the two treatments. Replens was given three times a week during the 12 weeks of the study, while Dienoestrol was administred daily during the first 2 weeks and thereafter three times a week. Vaginal dryness index, itching, irritation, dyspareunia, pH and safety were evaluated every week the first month and every month thereafter. Results: Both treatments had a significant increase on vaginal dryness index as soon as the first week of treatment, and the hormonal compound was significantly better than the non-hormonal one. All symptoms such as itching, irritation and dyspareunia significantly decreased or disappeared without any difference between the two treatments. For pH, no significant difference was seen either in each group or between the two groups. No adverse events related with the two drugs were found. Conclusion: This study shows that Replens applied vaginally three times a week, is a full therapy for all symptoms of vaginal atrophy as well as local estrogen. No serious adverse event was related. Replens is an alternative treatment to local estrogen and perhaps a good complement of systemic HRT in patient suffering from vaginal dryness.
References (7)
- BJ Oddens et al.
Has the climateric been medicalized? A study on the use of medication for climateric complaints in four countries
Maturitas
(1992) - LE Nachtigall
Comparative study: Replens∗ versus local estrogen in menopausal women
Fert Ster
(1994) - AA Haspel et al.
Endocrinological and clinical investigations in postmenopausal women following administration of a vaginal cream containing oestriol
Maturitas
(1981)
Cited by (229)
Evidence-Based Guidance for Breast Cancer Survivorship
2023, Hematology/Oncology Clinics of North AmericaSexual dysfunction in female cancer survivors: Addressing the problems and the remedies
2022, MaturitasThis narrative review examines current evidence regarding sexual function in female cancer survivors, focusing on the impact of cancer treatments as well as the evaluation and management of sexual concerns in this population. Sexual dysfunction in female cancer survivors is prevalent, yet underdiagnosed and undertreated. Many healthcare professionals feel ill-equipped to address the sexual health needs of female cancer survivors. Multiple direct and indirect factors can contribute to sexual dysfunction in female cancer survivors, including effects on the hormonal milieu and physical and sexual well-being. Factors influencing sexual function after cancer may be multifaceted, warranting a multidisciplinary approach to care. Validating and normalizing sexual health concerns and providing education and appropriate therapies, as well as timely referral to appropriate sexual health experts, are key to optimizing cancer survivorship care in women. Clinicians should, at a minimum, be aware of the various potential treatment modalities, taking into account contributing physical, psychological and interpersonal factors. Management of sexual health concerns should be individualized based on contributing factors.
Oncology Survivorship and Sexual Wellness for Women
2021, Urologic Clinics of North AmericaGenitourinary menopause syndrome. Postmenopausal women management: CNGOF and GEMVi clinical practice guidelines
2021, Gynecologie Obstetrique Fertilite et SenologieLe syndrome génito-urinaire de la ménopause (SGUM) est défini comme un ensemble de symptômes associés à une diminution des œstrogènes et autres stéroïdes sexuels lors de la ménopause. Les principaux symptômes sont vulvovaginaux (sécheresse, brûlure, irritation), sexuels (dyspareunie), et urinaires (infections urinaires, pollakiurie, nycturie, douleur à la miction, incontinence urinaire par urgenturie). Le SGUM entraîne une altération de la qualité de vie, en particulier de la sexualité des femmes.
L’objectif de ce travail est d’élaborer des recommandations pour la pratique clinique concernant la prise en charge du SGUM chez les femmes ménopausées, et en particulier, chez les femmes ayant un antécédent de cancer du sein, traitées ou non par hormonothérapie.
Une revue systématique de la littérature à propos de la prise en charge du SGUM a été réalisée sur Pubmed, Medline et Cochrane Library. Les recommandations des sociétés savantes internationales ont également été prises en compte : International Menopause society (IMS) https://www.imsociety.org, The North American Menopause society (NAMS) https://www.menopause.org, Canadian Menopause society https://www.sigmamenopause.com, European Menopause and Andropause Society (EMAS) https://www.emas-online.org, International Society for the Study of Women's Sexual Health (ISSWSH) https://www.isswsh.org.
L’utilisation de lubrifiants, hydratants et acide hyaluronique par voie vaginale entraîne une amélioration des symptômes du SGUM et pourra être proposée pour toutes les patientes. Pour les femmes ménopausées, les œstrogènes par voie locale seront préférés à la voie orale en raison de leur innocuité et efficacité sur l’ensemble des symptômes du SGUM lors d’une utilisation à faible dose. La Prastérone est un traitement local qui pourra être proposé comme alternative efficace pour la prise en charge de la dyspareunie et trouble de la fonction sexuelle. Les données actuelles concernant la testostérone par voie orale, la tibolone, la DHEA par voie orale ou transdermique et la phytothérapie sont actuellement limitées. L’Ospémifène qui a démontré une amélioration significative des symptômes, notamment sexuels, n’est actuellement pas commercialisé en France. Dans le cas particulier des femmes avec antécédent de cancer du sein, les schémas non hormonaux sont une thérapie de première ligne. Les données actuelles concernant le risque de récidive de cancer du sein lors de l’administration d’œstrogènes locaux faible dose sont rassurantes mais ne permettent pas de conclure à l’innocuité de ce traitement.
Le SGUM est un symptôme fréquent pouvant altérer la qualité de vie des femmes ménopausées. Une prise en charge devra être systématiquement proposée. Le traitement local non hormonal pourra être proposé chez toutes les femmes. L’œstrogénothérapie locale à faible dose et la Prastérone ont démontré un intérêt pour la prise en charge des symptômes du SGUM. Chez les femmes avant antécédent de cancer du sein, le traitement local non hormonal devra être proposé en première intention. L’innocuité de l’œstrogénothérapie locale à faible dose et de la Prastérone ne peut pas être établie actuellement. D’autres alternatives existent mais ne sont actuellement pas recommandées en France du fait du manque de données.
Genitourinary menopause syndrome (SGUM) is defined as a set of symptoms associated with a decrease of estrogen and other sexual steroids during menopause. The main symptoms are vulvovaginal (dryness, burning, itching), sexual (dyspareunia), and urinary (urinary infections, pollakiuria, nycturia, pain, urinary incontinence by urgenturia). SGUM leads to an alteration of the quality of life, and affects especially women's sexuality.
The objective of this review was to elaborate guidelines for clinical practice regarding the management of SGUM in postmenopausal women, and in particular, in women with a history of breast cancer, treated or not with hormone therapy.
A systematic review of the literature on SGUM management was conducted on Pubmed, Medline and Cochrane Library. Recommendations from international scholarly societies were also taken into account: International Menopause Society (IMS) https://www.imsociety.org, The North American Menopause Society (NAMS) https://www.menopause.org, Canadian Menopause Society https://www.sigmamenopause.com, European Menopause and Andropause Society (EMAS) https://www.emas-online.org, International Society for the Study of Women's Sexual Health (ISSWSH) https://www.isswsh.org.
Vaginal use of lubricants, moisturizers and hyaluronic acid improves the symptoms of SGUM and may be offered to all patients. For postmenopausal women, local estrogen will be preferred to the oral route because of their safety and efficacy on all symptoms of SGUM during low-dose use. Prasterone is a local treatment that can be proposed as an effective alternative for the management of dyspareunia and sexual function disorder. Current data on oral testosterone, tibolone, oral or transdermal DHEA and herbal medicine are currently limited. Ospemifène, which has shown a significant improvement in sexual symptoms, is not currently marketed in France. In the particular case of women with a history of breast cancer, non-hormonal regimens are a first-line therapy. Current data on the risk of breast cancer recurrence when administering low-dose local estrogen are reassuring but do not support a conclusion that this treatment is safe.
SGUM is a common symptom that can affect the quality of life of postmenopausal women. A treatment should be systematically proposed. Local non-hormonal treatment may be offered in all women. Local low-dose estrogen therapy and Prasterone has shown an interest in the management of symptoms. In women before a history of breast cancer, local non-hormonal treatment should be offered first-line. The safety of low-dose local estrogen therapy and Prasterone cannot be established at this time. Other alternatives exist but are not currently recommended in France due to lack of data.
Efficacy and safety of current therapies for genitourinary syndrome of menopause: A Bayesian network analysis of 29 randomized trials and 8311 patients
2021, Pharmacological ResearchGenitourinary syndrome of menopause (GSM) seriously affects the quality of life of women in this stage and patients with breast cancer, but optimal treatment options as well as risks associated with the complication remain controversial.
We aimed at exploring the safest and most effective treatment for genitourinary syndrome of menopause.
The study was performed following a pre-established protocol registered on PROSPERO (CRD42020180807). We searched through PubMed, Embase, Scopus, Cochrane Library, Web of Science and ScienceDirect electronic databases, clinicaltrials.gov and OVID for relevant data on Genitourinary syndrome of menopause provided by March 2020. Randomised controlled trials (RCTs) on women presenting with some or all the signs and symptoms for genitourinary syndrome of menopause were extracted and analyzed based on the Bayesian theory. The key variables were additionally evaluated using the network sub-analyses, standard pairwise comparisons, regression analysis and subgroup and sensitivity analyses. The pooled estimates were quantified as odd ratios or mean differences where appropriate, at 95 % confidence intervals.
In the end, 29 randomized controlled trials (RCTs) evaluating 5 different treatment regimens for genitourinary syndrome of menopause, involving 8311 patients, were included in the study. Laser therapy had excellent effect on vaginal dryness, dysparunia, urinary incontinence, proportion of parabasal cells, pH and VHI. Vaginal estrogen also had significant effects on these aspects, although its effect was inferior to that of laser therapy. Ospemifene therapy was however superior to laser and vaginal estrogen therapies in ameliorating sexual function, however, it presents a high risk of developing adverse events and endometrial hyperplasia. Moisturizer/lubricant was effective on dysparunia, proportion of parabasal cells and vaginal pH. In regression analysis, age was an essential factor affecting vaginal dryness and pH treatment effect.
Compared with other currently available interventional treatments for genitourinary syndrome of menopause, laser therapy, followed by vaginal estrogen, confers superior clinical outcomes for most aspects associated with the disease. In addition, they pose relatively low risks of developing adverse events. Ospemifene and DHEA therapies on their part significantly improve sexual function of women with GSM. A strong relationship between treatment effect and age provides insights for future studies on clinical treatment.
Management of genitourinary syndrome of menopause in female cancer patients: a focus on vaginal hormonal therapy
2020, American Journal of Obstetrics and GynecologyCitation Excerpt :Moisturizers work by hydrating the vaginal mucosa and lowering the vaginal pH,14 and are available as plant-based or synthetic polymers. Two studies found that Replens, a Food and Drug Administration (FDA)–approved vaginal moisturizer, caused equivalent subjective improvement of vaginal dryness when compared with vaginal estrogen therapy.15,16 Another nonhormonal treatment option for GSM is topical lidocaine.
Genitourinary syndrome of menopause is a condition describing the hypoestrogenic effects on the female genitals and lower urinary tract leading to symptoms such as vaginal dryness, vulvar and vaginal burning, dyspareunia and dysuria. Genitourinary syndrome of menopause is experienced by over half of postmenopausal women, and is even more pervasive in women with cancer. Due to treatments such as surgery, chemotherapy, radiation, and hormonal therapy, women may experience early menopause resulting in earlier and more severe symptoms. Understanding the scope of this issue in female breast and gynecologic cancer survivors and identifying treatment options for this complex patient population are paramount. Tailored patient treatments include nonhormonal therapies (vaginal moisturizers, lubricants, pelvic floor physical therapy, dilator therapy, counseling), systemic and local hormonal therapies. Consensus recommendations by medical societies and associated evidence are reviewed, with emphasis on safety and efficacy of local vaginal hormonal therapies, and management variations noted depending on cancer type and characteristics. With knowledge and understanding of the unmet need associated with under-recognition and under-treatment of genitourinary syndrome of menopause, providers caring for women with cancer are in a position to improve the quality of life of their patients by providing safe and effective treatments.