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Expert Opinion on Drug Delivery Nov 2020Vulvar and vaginal atrophy (VVA) affects up to two thirds of postmenopausal women, with symptoms of vaginal dryness, dyspareunia, and vulvar/vaginal irritation. Despite... (Review)
Review
INTRODUCTION
Vulvar and vaginal atrophy (VVA) affects up to two thirds of postmenopausal women, with symptoms of vaginal dryness, dyspareunia, and vulvar/vaginal irritation. Despite the availability of various treatments, women express dissatisfaction with their options. An estradiol (E2; 4-µg and 10-µg) softgel vaginal insert was approved by the Food and Drug Administration (FDA) to treat moderate to severe dyspareunia, a symptom of VVA, due to menopause. These inserts were designed to treat VVA effectively and safely while avoiding some of the drawbacks of other administration methods.
AREAS COVERED
This article reviews the physical characteristics and pharmacokinetic data of the E2 softgel vaginal insert. Primary and secondary efficacy endpoints and safety data are reviewed from the pivotal REJOICE trial (NCT02253173), and substudies that explore response rates, changes in vaginal epithelium by visual assessment, efficacy in patient subgroups, effects on sexual function, and patient satisfaction compared with other treatments.
EXPERT OPINION
The E2 insert shows that vaginal drug delivery is an optimal route of administration for locally treating VVA. This E2 softgel vaginal insert is a safe and effective treatment for symptoms of postmenopausal VVA. The E2 insert's pharmacokinetic characteristics are related to its unique formulation, rapid dissolution, and minimal systemic absorption.
ABBREVIATIONS
AE: adverse event; AUC: area under the concentration-time curve; BMI: body mass index; C: average concentration; CI: confidence interval; C: maximum concentration; C: minimum concentration; E2: estradiol; FDA: Food and Drug Administration; FSFI: Female Sexual Function Index; GSM: genitourinary symptoms of menopause: MBS: most bothersome symptom; NAMS: North American Menopause Society; OR: odds ratio; PI: pulsatility index; PK: pharmacokinetic; REVIVE: Real Women's Views of treatment options for menopausal Vaginal changEs; RI: resistance index; ROC: receiver operating characteristic; TEAE: treatment-emergent adverse event; t: time to maximum concentration; VVA: vulvar and vaginal atrophy.
Topics: Administration, Intravaginal; Atrophy; Dyspareunia; Estradiol; Female; Humans; Postmenopause; Treatment Outcome; Vagina; Vaginal Diseases; Vulvar Diseases
PubMed: 32877254
DOI: 10.1080/17425247.2020.1810662 -
Sexual and Reproductive Health Matters 2021Promoting sexual health is a World Health Organization (WHO) priority. Lubricants are widely available and used to improve sexual pleasure and reduce pain during... (Review)
Review
Promoting sexual health is a World Health Organization (WHO) priority. Lubricants are widely available and used to improve sexual pleasure and reduce pain during intercourse. To inform WHO's self-care interventions guideline, we conducted a systematic review of the peer-reviewed literature to answer the question: does use of lubricants during or prior to sex result in improved sexual health and well-being. We searched PubMed, CINAHL, LILACS and EMBASE on 8 July 2020 for effectiveness, values and preferences, and cost data related to commercially available vaginal and anal lubricants. Data were systematically extracted and qualitatively synthesised. Effectiveness evidence was summarised in GRADE evidence profiles. Seven studies met the effectiveness review criteria. Two randomised trials found lubricant use led to improved female sexual well-being and had no impact on incidence of human papillomavirus (moderate certainty evidence). One observational study with gay and bisexual men showed lubricants were associated with increased reports of pain during receptive intercourse and no difference in pain during insertive intercourse, but a reduced degree of pain in both types of intercourse (low/very low certainty evidence). One observational study with female breast cancer survivors found better outcomes of vaginal dryness and dyspareunia with lubricant use (very low certainty evidence). Twenty-one values and preferences studies from diverse populations globally found that most individuals supported lubricant use for reasons of comfort/reduced pain and sexual pleasure. No cost studies were identified. Although evidence is limited, lubricants appear to offer an acceptable approach to improving sexual health and well-being.
Topics: Bisexuality; Coitus; Female; Humans; Lubricants; Male; Observational Studies as Topic; Sexual Behavior; Sexual Health
PubMed: 35315312
DOI: 10.1080/26410397.2022.2044198 -
JCO Clinical Cancer Informatics Feb 2022To describe the development and implementation of a new digital health clinical tool (Gynecologic Survivorship Tool [GST]) for symptom management of women surgically... (Review)
Review
PURPOSE
To describe the development and implementation of a new digital health clinical tool (Gynecologic Survivorship Tool [GST]) for symptom management of women surgically treated for gynecologic cancer; to assess its feasibility; and to conduct a retrospective review of the data.
MATERIALS AND METHODS
The GST was developed on the basis of a comprehensive review of the literature, multidisciplinary expert opinion, and feedback from women with a history of gynecologic cancer. It is composed of 17 questions addressing six main categories-gynecologic health (abnormal bleeding/pain), lymphedema, vaginal/vulvar dryness, sexual health, menopause (hot flushes/sleep difficulties), and bowel/urinary issues. An electronic version using the Memorial Sloan Kettering Cancer Center Engage platform was piloted in two clinics for patients with endometrial or cervical cancer. Health information was generated into clinical summaries and identified concerns for actionable response. Associations of symptom and survey time point were assessed by longitudinal models using generalized estimating equations.
RESULTS
From January 1, 2019, to February 29, 2020, 3,357 GST assessments were assigned to 1,405 patients, with a 71% completion rate (90% within 5 minutes). Sixty-eight percent were performed at home via a patient portal, 32% at follow-ups using a clinic iPad. The most common symptoms were bowel problems, swelling/fluid, pain during examination, vaginal or vulvar dryness, and vaginal bleeding. Implementation challenges included improving patient compliance and ensuring that reports were reviewed by all clinical teams. We developed screening e-mails detailing patients whose assessments were due, planned training sessions for multidisciplinary teams, and incorporated feedback on methods for reviewing symptoms reports.
CONCLUSION
The GST demonstrated feasibility, a high completion rate, and minimal time commitment. It was an effective electronic reporting mechanism for patients, enabling the medical team to develop specific strategies for alleviating bothersome symptoms during follow-up.
Topics: Female; Genital Neoplasms, Female; Humans; Pain; Surveys and Questionnaires; Survivorship; Uterine Cervical Neoplasms
PubMed: 35239413
DOI: 10.1200/CCI.21.00154 -
Menopause (New York, N.Y.) Feb 2023To determine treatment priorities in women cancer patients attending a dedicated Menopausal Symptoms After Cancer service.
OBJECTIVE
To determine treatment priorities in women cancer patients attending a dedicated Menopausal Symptoms After Cancer service.
METHODS
Cancer type and stage were abstracted from medical records. Women ranked up to three symptoms as treatment priorities from the list "hot flushes/night sweats," "mood changes," "vaginal dryness or soreness," "sleep disturbances," "feeling tired or worn out (fatigue)," "sexual problems and/or pain with intercourse," "joint pain," and "something else" with free-text response. For each prioritized symptom, patients completed standardized patient-reported outcome measures to determine symptom severity and impact.
RESULTS
Of 189 patients, most had breast cancer (48.7%, n = 92), followed by hematological (25.8%, n = 49), gynecological (18.0%, n = 34), or colorectal (2.6%, n = 5). The highest (first-ranked) treatment priority was vasomotor symptoms (33.9%, n = 64), followed by fatigue (18.0%, n = 34), vaginal dryness/soreness (9.5%, n = 18), and sexual problems/pain with intercourse (9.5%, n = 18). Symptoms most often selected in the top three ("prioritized") were fatigue (57.7%, n = 109), vasomotor symptoms (57.1%, n = 108), and sleep disturbance (49.2%, n = 93). In patients who prioritized vasomotor symptoms, medians on the "problem," "distress," and "interference" dimensions of the Hot Flash Related Daily Interference Scale were, respectively, 6.0 (interquartile range [IQR], 5.0-8.0), 5.5 (IQR, 3.0-8.0), and 5.0 (IQR, 3.-7.0), indicating moderate severity. In patients who prioritized fatigue, the median Fatigue Scale score was 28 (IQR, 19-36), 37% worse than general population.
CONCLUSIONS
Vasomotor symptoms, fatigue, sexual problems, and vaginal dryness/soreness were the leading priorities for treatment. Understanding symptom severity and patient priorities will inform better care for this growing population.
Topics: Humans; Female; Menopause; Hot Flashes; Breast Neoplasms; Pain; Fatigue
PubMed: 36696637
DOI: 10.1097/GME.0000000000002108 -
Journal of Women's Health (2002) Nov 2020Vaginal dryness is a highly prevalent condition. Much of previous research has focused on postmenopausal women. The aim of this study was to evaluate the impact of... (Observational Study)
Observational Study
Vaginal dryness is a highly prevalent condition. Much of previous research has focused on postmenopausal women. The aim of this study was to evaluate the impact of vaginal dryness on a predominantly premenopausal sample of women. The study was conducted online. Participants with self-reported vaginal dryness completed the Work Productivity and Activity Impairment (WPAI) scale, and a generic quality-of-life instrument, the assessment of quality of life instrument (AQoL)-4D. Information regarding sociodemographics was also collected. National (United Kingdom) median age-specific weekly wages were used to derive the economic cost of vaginal dryness. A total of 524 women completed the study. The average age was 40.18 years (range 18-70 years) and just under 62% of the sample was premenopausal. Around 40% of women reported severe or very severe vaginal dryness. The average AQoL-4D score was 0.584 (standard deviation [SD]: 0.286) and decreased in line with level of severity ( = 0.014). Quality of life was not related to either age ( = 0.14) or menopausal status ( = 0.055). Of those women in employment ( = 369), 16.5% (SD: 24.3%) of their working hours were lost due to vaginal dryness; work impairment level was 34.4% (SD: 31.8%). The average lost weekly wage was £67.82 (SD: £130.88). The estimated average loss to employers was £82.56 (SD: £109.38) with a total weekly loss of £31,622. This study has shown the significant impact vaginal dryness has on premenopausal and postmenopausal women in terms of quality of life and economic burden, as well as the potential cost of this condition to society.
Topics: Adult; Aged; Cost of Illness; Female; Humans; Middle Aged; Perimenopause; Postmenopause; Premenopause; Quality of Life; Sexual Dysfunction, Physiological; United Kingdom; Vaginal Diseases
PubMed: 32833577
DOI: 10.1089/jwh.2019.8001 -
FP Essentials Apr 2022(GSM) is a term that describes the genital, urinary, and sexual changes that occur in women because of a lack of estrogen. This most commonly is because of menopause,...
(GSM) is a term that describes the genital, urinary, and sexual changes that occur in women because of a lack of estrogen. This most commonly is because of menopause, but can be because of a hypoestrogenic state caused by hyperprolactinemia, oophorectomy, premature ovarian failure, chemotherapy, or radiation. GSM describes a group of signs and symptoms that affect quality of life and progress over time, including vaginal dryness, dyspareunia, dysuria, urinary urgency, and frequent urinary tract infections. GSM is underdiagnosed. It affects 65% of women 1 year after the onset of menopause, and 84% of women 6 years after menopause. Physicians routinely should ask all perimenopausal and postmenopausal women about GSM symptoms. The diagnosis is made clinically, based on the history and physical examination. Use of nonhormonal lubricants and vaginal moisturizers should be recommended as first-line therapies. Vaginal estrogen is the most effective treatment. Other therapies include vaginal dehydroepiandrosterone (DHEA), ospemifene, systemic estrogen therapy, and pelvic floor physical therapy.
Topics: Estrogens; Female; Humans; Lubricants; Menopause; Quality of Life; Syndrome
PubMed: 35420405
DOI: No ID Found -
Journal of Pharmacy Practice Jun 2024Hormone replacement therapy (HRT) is considered the gold standard for management of vasomotor and vaginal symptoms of menopause. Vasomotor symptoms of menopause may... (Review)
Review
Hormone replacement therapy (HRT) is considered the gold standard for management of vasomotor and vaginal symptoms of menopause. Vasomotor symptoms of menopause may include hot flashes and diaphoresis that vary in intensity and duration. Other symptoms of menopause can include vaginal atrophy and dryness, leading to dyspareunia and increased risk of infection. These symptoms can be impactful on a woman's life and HRT has data to support its efficacy, however, HRT carries significant risks that are generally well known, including risk of stroke, cardiovascular disease, breast cancer, and venous thromboembolism. These risks were most well characterized by several landmark trials published in the early 2000s. There are several nuances to prescribing HRT that can make doing so complex. These include consideration of cyclic vs continuous administration and of tapering therapy. Additionally, estrogen is available in a variety of dosage forms including injections and transdermal formulations. However, for women with an intact uterus, estrogen will need to be combined with progestin or bazedoxifene (a selective estrogen receptor modulator - SERM), both once daily oral formulations, in order to minimize malignancy risk. Though product preference and considerations of dosing may vary depending on practitioner preference, this brief report aims to clarify some nuances to prescribing or recommending HRT.
Topics: Humans; Menopause; Female; Estrogen Replacement Therapy; Hormone Replacement Therapy; Estrogens; Hot Flashes; Selective Estrogen Receptor Modulators
PubMed: 37002679
DOI: 10.1177/08971900231167925 -
Managing Genitourinary Syndrome of Menopause in Breast Cancer Survivors Receiving Endocrine Therapy.Journal of Oncology Practice Jul 2019Patients with breast cancer receiving antiestrogen therapy, specifically aromatase inhibitors, often suffer from vaginal dryness, itching, irritation, dyspareunia, and... (Review)
Review
Patients with breast cancer receiving antiestrogen therapy, specifically aromatase inhibitors, often suffer from vaginal dryness, itching, irritation, dyspareunia, and dysuria, collectively known as genitourinary syndrome of menopause (GSM). GSM can decrease quality of life and is undertreated by oncologists because of fear of cancer recurrence, specifically when considering treatment with vaginal estrogen therapy because of unknown levels of systemic absorption of estradiol. In this article, we review the available literature for treatment of GSM in patients with breast cancer and survivors, including nonhormonal, vaginal hormonal, and systemic hormonal therapy options. First-line treatment includes nonhormonal therapy with vaginal moisturizers, lubricants, and gels. Although initial studies showed significant improvement in symptoms, the US Food and Drug Administration recently issued a warning against CO laser therapy for treatment of GSM until additional studies are conducted. In severe or refractory GSM, after discussing risks and benefits of vaginal hormonal therapy, the low-dose 10-μg estradiol-releasing intravaginal tablet or lower-dose 4 μg estrogen vaginal insert and intravaginal dehydroepiandrosterone (prasterone) are options for treatment, because studies show minimal elevation in serum estradiol levels and significant improvement in symptoms. The decision to offer vaginal estrogen therapy must be individualized and made jointly with the patient and her oncologist.
Topics: Aromatase Inhibitors; Breast Neoplasms; Cancer Survivors; Dehydroepiandrosterone; Estrogens; Female; Female Urogenital Diseases; Humans; Laser Therapy; Lubricants; Menopause; Syndrome; Testosterone
PubMed: 31291563
DOI: 10.1200/JOP.18.00710 -
Climacteric : the Journal of the... Aug 2023This review analyzes the clinical associations between specific low genitourinary tract clinical circumstances in perimenopausal and postmenopausal women living with... (Review)
Review
This review analyzes the clinical associations between specific low genitourinary tract clinical circumstances in perimenopausal and postmenopausal women living with human immunodeficiency virus (WLHIV). Modern antiretroviral therapy (ART) improves survival and reduces opportunistic infections and HIV transmission. Despite appropriate ART, WLHIV may display menstrual dysfunction, risk of early menopause, vaginal microbiome alterations, vaginal dryness, dyspareunia, vasomotor symptoms and low sexual function as compared to women without the infection. They have increased risks of intraepithelial and invasive cervical, vaginal and vulvar cancers. The reduced immunity capacity may also increase the risk of urinary tract infections, side-effects or toxicity of ARTs, and opportunistic infections. Menstrual dysfunction and early menopause may contribute to the early onset of vascular atherosclerosis and plaque formation, and increased osteoporosis risks requiring specific early interventions. On the other hand, the association between being postmenopausal and having a low sexual function is significant and related to low adherence to ART. WLHIV deserve a specific approach to manage different low genitourinary risks and complications related to hormone dysfunction and early menopause.
Topics: Female; Humans; Menopause; HIV; Vaginal Diseases; Vagina; Dyspareunia
PubMed: 37054721
DOI: 10.1080/13697137.2023.2194528 -
Frontiers in Reproductive Health 2021The estrogen decrease in postmenopausal women results in functional and anatomical changes in the genitourinary tract. The most prevalent and bothersome symptoms are... (Review)
Review
The estrogen decrease in postmenopausal women results in functional and anatomical changes in the genitourinary tract. The most prevalent and bothersome symptoms are vaginal dryness, dyspareunia, and reduced lubrication, which can significantly affect the quality of life of these women, principally those who are sexually active. Hormonal therapy with local estrogens is generally considered the "gold standard." However, there are cases in which there are clinical concerns about its use or women opt for non-hormonal options. Thus, safe and effective non-hormonal options are needed to improve symptoms in these women. Moisturizers and lubricants are first-line therapy for breast cancer survivors.
PubMed: 36303977
DOI: 10.3389/frph.2021.781353