Vulvar and Vaginal Atrophy

Lev‐Sagie, Ahinoam

doi:10.1097/grf.0000000000000126

Cited by 91 publications

(24 citation statements)

References 21 publications

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“…VVA is a widespread condition, with symptoms affecting around half of all peri- and postmenopausal women 16 . These symptoms can have a substantial negative impact on interpersonal relationships, quality of life, daily activities, and sexual function 17 .…”

Section: Introductionmentioning

confidence: 99%

“…Evidence suggests that a lack of awareness among women about the physiological changes associated with the menopause and the availability of effective and well-tolerated treatments, reluctance to discuss symptoms with HCPs, safety concerns, inconvenience, and inadequate symptom relief from available treatments are potential barriers to seeking and using treatment 16 , 17 .…”

Section: Introductionmentioning

confidence: 99%

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Treating vulvovaginal atrophy/genitourinary syndrome of menopause: how important is vaginal lubricant and moisturizer composition?

Edwards¹,

2015

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Vaginal dryness is a common condition that is particularly prevalent during and after the menopause, and is one of the symptoms of vulvovaginal atrophy/genitourinary syndrome of menopause. The impact of vaginal dryness on interpersonal relationships, quality of life, daily activities, and sexual function can be significant, but is frequently underestimated. Furthermore, barriers exist to treatment-seeking, and this condition is often underreported and undertreated. Greater education about vaginal dryness and the range of available treatments is essential to encourage more women to seek help for this condition.Personal lubricants and moisturizers are effective at relieving discomfort and pain during sexual intercourse for women with mild to moderate vaginal dryness, particularly those who have a genuine contraindication to estrogen, or who choose not to use estrogen. However, there is a distinction between lubricants and moisturizers, and notable differences between commercially available products. Women should be advised to choose a product that is optimally balanced in terms of both osmolality and pH, and is physiologically most similar to natural vaginal secretions. A series of recommendations for the use of vaginal lubricants and moisturizers, either on their own or in combination with systemic or topical hormone replacement therapy, is presented.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Treating vulvovaginal atrophy/genitourinary syndrome of menopause: how important is vaginal lubricant and moisturizer composition?

Edwards¹,

2015

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“…1 A component of genitourinary syndrome of menopause, 2 VVA is a chronic, progressive condition that clinically manifests as vaginal dryness, irritation, dysuria, and pain (dyspareunia) or bleeding with sexual activity. 3 VVA, unlike vasomotor symptoms, is progressive and not likely to resolve without treatment. 4 …”

Section: Introductionmentioning

confidence: 99%

Consistency of Effect with a Low-Dose, Estradiol Vaginal Capsule (TX-004HR): Evaluating Improvement in Vaginal Physiology and Moderate-to-Severe Dyspareunia in Subgroups of Postmenopausal Women

Constantine¹,

Bouchard

Pickar

et al. 2017

Journal of Women's Health

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Background: The 12-week, randomized, double-blind, placebo-controlled, multicenter, phase 3 REJOICE trial demonstrated that TX-004HR, an investigational, applicator-free, low-dose vaginal softgel capsule containing solubilized 17β-estradiol, effectively and rapidly treats symptoms of vulvar and vaginal atrophy (VVA) with negligible to very low systemic absorption. The aim of this analysis was to assess whether the efficacy of TX-004HR varies with age, body mass index (BMI), uterine status, pregnancy status, and vaginal delivery.Methods: The REJOICE trial evaluated the efficacy of 4-, 10-, and 25-μg doses of TX-004HR in postmenopausal women (40–75 years) with VVA and a self-identified most bothersome symptom of moderate-to-severe dyspareunia. Prespecified subgroup analyses of the four co-primary endpoints (percentages of superficial cells and parabasal cells, vaginal pH, and severity of dyspareunia) were analyzed with respect to age, BMI, uterine status, pregnancy status, and vaginal births. Each dose was compared with placebo for change from baseline to week 2 through week 12, respectively.Results: TX-004HR significantly improved superficial cells, parabasal cells, and vaginal pH from baseline to weeks 2 and 12 in most subgroups. All TX-004HR doses numerically reduced the severity of dyspareunia by 2 weeks and maintained efficacy over 12 weeks, with many of the subgroups having statistically significant improvement relative to placebo.Conclusions: TX-004HR was efficacious for treating symptomatic VVA, and it demonstrated a consistency of effect when women's age, BMI, uterine status, pregnancy status, and vaginal births were evaluated. Clinical Trial Identifier: NCT02253173.

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“…VVA is a component of the genitourinary syndrome of menopause (GSM), and collectively includes changes to the labia majora/minora, clitoris, vestibule/introitus, vagina, urethra, and bladder. 1 , 2 A review of surveys reported up to two-thirds of women have physical evidence of VVA, 3 and approximately 50% of postmenopausal women have VVA symptoms. 4 These symptoms may include vaginal dryness, irritation, itching, dysuria, and/or pain or bleeding with sexual activity.…”

mentioning

confidence: 99%

Visual improvements in vaginal mucosa correlate with symptoms of VVA: data from a double-blind, placebo-controlled trial

Simon¹,

Archer

Kagan

et al. 2017

Menopause

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Objective:To evaluate the response of the vaginal mucosa with TX-004HR and its correlation with vulvar and vaginal atrophy (VVA) symptoms, and whether visual examination is a useful measure for assessing VVA.Methods:REJOICE was a 12-week, phase 3, multicenter, randomized, double-blind, placebo-controlled study of a vaginal, muco-adhesive, 17β-estradiol softgel capsule (TX-004HR 4, 10, and 25 μg) in postmenopausal women with VVA and moderate-to-severe dyspareunia. Treatments were self-administered vaginally once per day for 2 weeks, then twice per week for 10 weeks. The vagina was visually examined at baseline and at weeks 2, 6, 8, and 12; changes were evaluated using a 4-item scale for vaginal color, vaginal epithelial integrity, vaginal epithelial surface thickness, and vaginal secretions.Results:Significant improvements were observed with all three TX-004HR doses versus placebo in vaginal color (least square mean score changes of −0.96 to −1.06 for TX-004HR doses vs −0.60 for placebo at week 12), epithelial integrity (−0.97 to −1.07 vs −0.60), epithelial surface thickness (−0.94 to −1.03 vs −0.61), and secretions (−1.01 to −1.06 vs −0.64) (P < 0.001 for all comparisons at all time points). Both Pearson's correlations and logistic regression receiver-operating characteristic curve analyses significantly correlated the sum of the individual visual assessment scores with dyspareunia (P < 0.0001) and vaginal dryness (P < 0.0001) at 12 weeks.Conclusions:Greater improvements in the vaginal mucosa of postmenopausal women with VVA and moderate-to-severe dyspareunia were observed with TX-004HR versus placebo, and vaginal mucosa assessment scores correlated with vaginal symptoms of dyspareunia and dryness. Visual vaginal assessment by healthcare professionals is a useful measure for diagnosing VVA and assessing response to treatment.

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Vulvar and Vaginal Atrophy

Cited by 91 publications

References 21 publications

Treating vulvovaginal atrophy/genitourinary syndrome of menopause: how important is vaginal lubricant and moisturizer composition?

Treating vulvovaginal atrophy/genitourinary syndrome of menopause: how important is vaginal lubricant and moisturizer composition?

Consistency of Effect with a Low-Dose, Estradiol Vaginal Capsule (TX-004HR): Evaluating Improvement in Vaginal Physiology and Moderate-to-Severe Dyspareunia in Subgroups of Postmenopausal Women

Visual improvements in vaginal mucosa correlate with symptoms of VVA: data from a double-blind, placebo-controlled trial

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