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Vaginal Dryness

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1. Topical treatment of vaginal dryness with a non-hormonal cream in women undergoing breast cancer treatment - An open prospective multicenter study. Full Text available with Trip Pro

Topical treatment of vaginal dryness with a non-hormonal cream in women undergoing breast cancer treatment - An open prospective multicenter study. This open, prospective, multicenter, observational study was performed to investigate the efficacy and safety of a non-hormonal cream in women undergoing breast cancer treatment and experiencing vulvovaginal dryness symptoms. Overall, 128 patients from 22 study centers participated. The cream was applied to the vagina and vulva for 28 days (...) . For the efficacy analysis, changes in subjective symptoms (feeling of dryness, itching, burning, pain independent of sexual intercourse, dyspareunia, urinary incontinence) were evaluated. Additionally, the following objective diagnostic findings were assessed by a physician: thinning of vaginal epithelium, redness, petechiae, and discharge. Safety and tolerability were assessed by evaluating type and frequency of adverse events, including adverse medical device-related effects. The frequency and intensity

2019 PLoS ONE

2. A Randomized, Multicenter, Double-Blind, Study to Evaluate the Safety and Efficacy of Estradiol Vaginal Cream 0.003% in Postmenopausal Women with Vaginal Dryness as the Most Bothersome Symptom Full Text available with Trip Pro

A Randomized, Multicenter, Double-Blind, Study to Evaluate the Safety and Efficacy of Estradiol Vaginal Cream 0.003% in Postmenopausal Women with Vaginal Dryness as the Most Bothersome Symptom Vulvovaginal atrophy (VVA) is characterized by vaginal/vulvar dryness, irritation, dyspareunia, or dysuria. The objective of this study was to examine the efficacy and safety of a very low-dose estradiol vaginal cream (0.003%) applied twice per week in postmenopausal women with VVA-related vaginal (...) dryness.In this phase 3, randomized, double-blind, placebo-controlled, multicenter study, postmenopausal women with moderate-severe vaginal dryness as the most bothersome VVA symptom were randomized (1:1) to estradiol cream 0.003% (15 μg estradiol; 0.5 g cream) or placebo (0.5 g cream). Treatments were applied vaginally once daily for 2 weeks followed by two applications/week for 10 weeks. Coprimary outcomes were changes in severity of vaginal dryness, percentage of vaginal superficial and parabasal

2018 Journal of Women's Health Controlled trial quality: predicted high

3. Efficacy and safety of ospemifene in postmenopausal women with moderate-to-severe vaginal dryness: a phase 3, randomized, double-blind, placebo-controlled, multicenter trial. Full Text available with Trip Pro

Efficacy and safety of ospemifene in postmenopausal women with moderate-to-severe vaginal dryness: a phase 3, randomized, double-blind, placebo-controlled, multicenter trial. To evaluate the safety and efficacy of ospemifene for the treatment of moderate to severe vaginal dryness in postmenopausal women with vulvovaginal atrophy (VVA).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.Women (n = 631; ospemifene [n = 316], placebo [n = 315]) had a mean age of 59.8

2019 Menopause Controlled trial quality: predicted high

4. Monurelle Biogel<sup>®</sup> vaginal gel in the treatment of vaginal dryness in postmenopausal women. (Abstract)

Monurelle Biogel® vaginal gel in the treatment of vaginal dryness in postmenopausal women. To evaluate efficacy, tolerability and safety of Monurelle Biogel® vaginal gel for treatment of vaginal dryness.Multicenter, national, randomized, controlled vs. no-treatment, open-label study. Ninety-five postmenopausal women were randomized (48 to Monurelle Biogel® and 47 to no treatment). Primary endpoint was the change of Verbal Rating Scale (VRS) total score of vaginal atrophy (VA (...) on day 56.Monurelle Biogel® vaginal gel applied twice daily for 8 weeks is effective in relieving vaginal dryness and other VA symptoms. Such a clinical meaningful effect persists at least 4 weeks and is supported by an improvement in the vaginal environment. Trial Registration clinicaltrials.gov Identifier: NCT02994342.

2017 Climacteric Controlled trial quality: uncertain

5. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. (Abstract)

Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. The aim of this study is to confirm the local beneficial effects of intravaginal dehydroepiandrosterone (DHEA, Prasterone) on moderate to severe dyspareunia or pain at sexual activity, the most frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause (GSM (...) (P = 0.0002). On the other hand, moderate to severe vaginal dryness present in 84.0% of women improved at 12 weeks by 1.44 severity score unit compared to baseline, or 0.27 unit over placebo (P = 0.004). At gynecological evaluation, vaginal secretions, epithelial integrity, epithelial surface thickness, and color all improved by 86% to 121% over the placebo effect (P < 0.0001 for all comparisons with placebo). Serum steroid levels remained well within the normal postmenopausal values according

2018 Menopause Controlled trial quality: predicted high

6. Factors associated with developing vaginal dryness symptoms in women transitioning through menopause: a longitudinal study. Full Text available with Trip Pro

Factors associated with developing vaginal dryness symptoms in women transitioning through menopause: a longitudinal study. To evaluate factors associated with incident self-reported vaginal dryness and the consequences of this symptom across the menopausal transition in a multiracial/ethnic cohort of community-dwelling women.We analyzed questionnaire and biomarker data from baseline and 13 approximately annual visits over 17 years (1996-2013) from 2,435 participants in the Study of Women's (...) Health Across the Nation, a prospective cohort study. We used discrete-time Cox proportional-hazards regression to identify predictors of incident vaginal dryness and to evaluate vaginal dryness as a predictor of pain during intercourse and changes in sexual intercourse frequency.The prevalence of vaginal dryness increased from 19.4% among all women at baseline (ages 42-53 years) to 34.0% at the 13th visit (ages 57-69 years). Advancing menopausal stage, surgical menopause, anxiety, and being married

2018 Menopause

7. Vaginal Dryness

Vaginal Dryness Vaginal Dryness Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Vaginal Dryness Vaginal Dryness Aka: Vaginal Dryness (...) , Vaginal Lubricant From Related Chapters II. Definition Vaginal Dryness Inadequate vaginal lubrication which may lead to vaginal friction and microtrauma to the vulvar and vaginal epithelium May result in III. Causes Sexual arousal disorder See Inability to obtain or maintain adequate lubrication from sexual excitement Dissatisfaction with sexual relationship Negative body image Fear of Sexual abuse history Restrictive sexual beliefs Chronic Vaginal Dryness See deficiency Decreased perfusion Peripheral

2018 FP Notebook

8. Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy

Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy - Full Text View (...) - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness

2016 Clinical Trials

9. Vaginal Testosterone Cream vs Estradiol Vaginal Ring for Vaginal Dryness or Decreased Libido in Women Receiving Aromatase Inhibitors for Early-Stage Breast Cancer: A Randomized Clinical Trial. (Abstract)

Vaginal Testosterone Cream vs Estradiol Vaginal Ring for Vaginal Dryness or Decreased Libido in Women Receiving Aromatase Inhibitors for Early-Stage Breast Cancer: A Randomized Clinical Trial. Aromatase inhibitors (AI) are associated with significant urogenital atrophy, affecting quality of life and drug compliance.To evaluate safety of intravaginal testosterone cream (IVT) or an estradiol-releasing vaginal ring (7.5 μg/d) in patients with early-stage breast cancer (BC) receiving an AI (...) . Intervention was considered unsafe if more than 25% of patients had persistent elevation in estradiol (E2), defined as E2 greater than 10 pg/mL (to convert to pmol/L, multiply by 3.671) and at least 10 pg/mL above baseline after treatment initiation on 2 consecutive tests at least 2 weeks apart.Postmenopausal (PM) women with hormone receptor (HR)-positive stage I to III BC taking AIs with self-reported vaginal dryness, dyspareunia, or decreased libido were randomized to 12 weeks of IVT or an estradiol

2016 JAMA oncology Controlled trial quality: uncertain

10. 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. (Abstract)

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. 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.Randomized clinical trial (RCT) (Z7213M01).Five University Gynaecological Units.Ninety-five (...) <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.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.Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

2016 European journal of obstetrics, gynecology, and reproductive biology Controlled trial quality: uncertain

11. Efficacy and Tolerability Study of ZP-025 Vaginal Gel for the Treatment of Vaginal Dryness

Efficacy and Tolerability Study of ZP-025 Vaginal Gel for the Treatment of Vaginal Dryness Efficacy and Tolerability Study of ZP-025 Vaginal Gel for the Treatment of Vaginal Dryness - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more (...) studies before adding more. Efficacy and Tolerability Study of ZP-025 Vaginal Gel for the Treatment of Vaginal Dryness The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02994342 Recruitment Status : Completed First Posted : December 15, 2016 Last Update Posted : June 28, 2017 Sponsor: Zambon SpA

2016 Clinical Trials

12. Safety, efficacy, and tolerability of differential treatment to prevent and treat vaginal dryness and vulvovaginitis in diabetic women. (Abstract)

Safety, efficacy, and tolerability of differential treatment to prevent and treat vaginal dryness and vulvovaginitis in diabetic women. Problems affecting the vaginal tract in diabetic women are very often neglected. The efficacy and safety of three gynecological treatments in diabetic women have been assessed.A single-blind randomized progressive trial on 48 diabetic women affected by vaginal dryness, dyspareunia, and recurrent Candida infections was carried out. The ICIQ Vaginal Symptoms (...) improvement was also observed in Group 2.The proposed treatment with DermoXEN® Ultracalming Special for diabetics and DermoXEN® Vitexyl vaginal gel exert effective moisturizing and soothing action. Indeed, the aforementioned products have been proven effective for the main gynecological problems of diabetic women.

2016 Clinical and experimental obstetrics & gynecology Controlled trial quality: uncertain

13. [Efficacy of a medical device containing liposomal hyaluronic acid against vulvo-vaginal dryness]. (Abstract)

[Efficacy of a medical device containing liposomal hyaluronic acid against vulvo-vaginal dryness]. Hyaluronic acid (HA) is present in the vulval and vaginal conjonctive tissue. It possesses hydrating and healing properties and is indicated to treat menopause induced vulvo-vaginal atrophy. The goal of this study is to evaluate the efficacy of a medical device containing liposomal HA upon patients of different ages suffering from vulvo-vaginal dryness (VVD).Tested product Mucogyne® was applied 3 (...) times a week for 84 days by 47 patients, 28 premenopausal young women (mean age: 32 years old) and 19 post-menopausal women (mean age: 57.5 years old) all suffering from VVD associated to spontaneous pain and dyspareunia. Clinical evaluations and Vaginal Health Index (VHS) were calculated at 0, 1 and 3 months.A significant clinical improvement (P<0.001) occurred at 1 month (-25 % for dryness and -46 % for pain) and at 3 months (respectively -86 and -79 %). VHS was significantly improved (P<0.001

2016 Gynecologie, obstetrique & fertilite Controlled trial quality: uncertain

14. Efficacy and safety of non-hormonal remedies for vaginal dryness: open, prospective, randomized trial. (Abstract)

Efficacy and safety of non-hormonal remedies for vaginal dryness: open, prospective, randomized trial. To prove non-inferiority of the first non-hormonal vaginal cream in Germany, Vagisan(®) Moisturising Cream (CREAM), compared to a non-hormonal vaginal gel (GEL) for vulvovaginal atrophy (VVA) symptom relief.This was a 12-week multicenter, open-label, prospective, randomized, two-period, cross-over phase-III trial. The primary endpoint was the cumulative VVA subjective symptom score (...) of the respective treatment period. Secondary endpoints were assessment of single VVA subjective and objective symptoms, VVA objective symptom score, vaginal pH, safety parameters, overall assessment of efficacy, tolerability and evaluation of product properties. In total, 117 women were randomly allocated to either one of the two treatments, each administered for 4 weeks; 92 women were included in the per-protocol analysis (primary analysis). The main outcome measure was cumulative VVA subjective symptom

2016 Climacteric : the journal of the International Menopause Society Controlled trial quality: uncertain

15. Vaginitis

., atrophic vaginitis). Bacterial vaginosis, trichomoniasis, and candidiasis are types of infections that cause vaginitis. History and exam presence of risk factors vaginal discharge dysuria discharge adherent to vaginal mucosa prior episodes pruritus vulvodynia vaginal dryness dyspareunia erythema pale epithelium shiny epithelium decreased elasticity friable epithelium fever vaginal bleeding abdominal pain strawberry cervix douching poor or excessive hygiene antibiotic use change in feminine hygiene (...) Vaginitis Vaginitis - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  Vaginitis Last reviewed: February 2019 Last updated: June 2018 Summary Bacterial vaginosis continues to be a leading cause of vaginitis; other common infectious causes include trichomoniasis and candidiasis, although non-infectious causes are also possible. Affects all age groups of women, particularly during their reproductive years. Common symptoms

2018 BMJ Best Practice

16. Assessment of hot flushes and vaginal dryness among obese women undergoing bariatric surgery. (Abstract)

Assessment of hot flushes and vaginal dryness among obese women undergoing bariatric surgery. Menopausal symptoms are associated with a negative impact on the quality of life, leading women to seek medical treatment. Obesity has been linked to higher levels of menopausal symptoms such as hot flushes. This assessment will explore whether the prevalence and bother of hot flushes and vaginal dryness change from pre- to post-bariatric surgery among obese midlife women.This study is a longitudinal (...) analysis of data from 69 women (ages 35-72 years) undergoing bariatric surgery with reported reproductive histories and menopausal symptoms at preoperative and 6-month postoperative visits. Prevalence of and degree of bother of hot flushes and vaginal dryness at pre- and post-surgery were compared using McNemar's test and Wilcoxon signed-rank test.The reported degree of bother of symptoms associated with hot flushes decreased from pre- to post-surgery (p < 0.01). There was no significant change

2015 Climacteric

17. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. (Abstract)

Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. The aim of this study is to confirm the local beneficial effects of intravaginal dehydroepiandrosterone (DHEA, Prasterone) on moderate to severe dyspareunia or pain at sexual activity, the most frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause (GSM (...) (P = 0.0002). On the other hand, moderate to severe vaginal dryness present in 84.0% of women improved at 12 weeks by 1.44 severity score unit compared to baseline, or 0.27 unit over placebo (P = 0.004). At gynecological evaluation, vaginal secretions, epithelial integrity, epithelial surface thickness, and color all improved by 86% to 121% over the placebo effect (P < 0.0001 for all comparisons with placebo). Serum steroid levels remained well within the normal postmenopausal values according

2015 Menopause Controlled trial quality: predicted high

18. Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause

Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove (...) one or more studies before adding more. Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02638337 Recruitment Status : Completed First Posted : December 23, 2015 Last Update Posted : May 11, 2018

2015 Clinical Trials

19. Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness.

Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness. Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness. - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study (...) Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov

2015 Clinical Trials

20. Investigation on the Efficacy of WO 2085 Moisturising Cream for Breast Cancer Patients Suffering From Vulvovaginal Dryness

of dryness, itching) [ Time Frame: Baseline, after 4 weeks ] Each symptom is rated according to severity on a scale from 0 to 4 (0=not present, 1=hardly pronounced, 2=moderately pronounced, 3=quite pronounced, 4=very pronounced) Secondary Outcome Measures : Change from Baseline of objective vulvovaginal atrophy symptoms (e.g. thinning of the vaginal epithelium, redness) [ Time Frame: 4 weeks ] Each symptom is rated according to severity on a scale from 0 to 4 (0=not present, 1=hardly pronounced, 2 (...) in the study is present Exclusion Criteria: Women who suffered symptoms of vulvovaginal dryness prior to the start of tumour treatment Patients undergoing radiation therapy Patients with other tumours A current vaginal infection Medical conditions related to the vulva or vagina Current additional therapy of vulvovaginal dryness or vulvovaginal atrophy Women who are not able to participate properly in this study Current alcohol and/or drug abuse Pregnant or lactating women Contacts and Locations Go

2018 Clinical Trials

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