Vaginal Dryness

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David F. Archer - One of the best experts on this subject based on the ideXlab platform.

  • Ospemifene for the treatment of menopausal Vaginal Dryness, a symptom of the genitourinary syndrome of menopause.
    Expert review of endocrinology & metabolism, 2019
    Co-Authors: David F. Archer, Steven R. Goldstein, James A. Simon, David Portman, Irwin Goldstein
    Abstract:

    Introduction: VulvoVaginal atrophy (VVA), a component of the genitourinary syndrome of menopause, is a progressive condition due to decline in estrogen leading to Vaginal and vulvar epithelial changes. Accompanying symptoms of Dryness, irritation, burning, dysuria, and/or dyspareunia have a negative impact on quality of life. Ospemifene is a selective estrogen receptor modulator (SERM) approved by the FDA for moderate to severe dyspareunia and Vaginal Dryness due to postmenopausal VVA. Areas covered: PubMed was searched from inception to March 2019 with keywords ospemifene and vulvar Vaginal atrophy to review preclinical and clinical data describing the safety and efficacy of ospemifene for Vaginal Dryness and dyspareunia due to VVA. Covered topics include efficacy of ospemifene on Vaginal cell populations, Vaginal pH, and most bothersome VVA symptoms; imaging studies of vulvar and Vaginal tissues; effects on sexual function; and safety of ospemifene on endometrium, cardiovascular system, and breast. Expert opinion: Ospemifene is significantly more effective than placebo in all efficacy analyses studied, working through estrogen receptors and possibly androgen receptors. Safety as assessed by adverse events was generally comparable to that with placebo and to other SERMs, and/or adverse events were not clinically meaningful. No cases of endometrial or breast cancer were reported.

  • TX-004HR clinically improves symptoms of vulvar and Vaginal atrophy in postmenopausal women.
    Climacteric : the journal of the International Menopause Society, 2019
    Co-Authors: James A. Simon, David F. Archer, R Kagan, Ginger D. Constantine, Brian Bernick, S. Graham, Sebastian Mirkin
    Abstract:

    AbstractObjective: This study aimed to evaluate improvement of dyspareunia and associated Vaginal Dryness with a 17β-estradiol softgel Vaginal insert (TX-004HR; TherapeuticsMD, Boca Raton, FL, USA)...

  • Efficacy and safety of ospemifene in postmenopausal women with moderate-to-severe Vaginal Dryness: a phase 3, randomized, double-blind, placebo-controlled, multicenter trial
    Menopause (New York N.Y.), 2019
    Co-Authors: David F. Archer, Steven R. Goldstein, James A. Simon, Arthur Waldbaum, Steven A. Sussman, Corrado Altomare, Julie Zhu, Yuki Yoshida, Sam Schaffer, Graziella Soulban
    Abstract:

    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 years, a mean body mass index of 27.2 kg/m, and most were white. Ospemifene significantly improved (P < 0.0001) the percentages of parabasal and superficial cells, Vaginal pH, and severity of Vaginal Dryness severity compared with placebo at week 12; significant between-group differences were noted by week 4. Secondary endpoints of dyspareunia (P < 0.001), maturation value (P < 0.0001), and the Female Sexual Function Index (P < 0.05) also significantly improved with ospemifene versus placebo at week 12. Significantly more women responded (31.5% vs 6.0%; P < 0.0001) or were satisfied (49.2% vs 33.8%; P = 0.0007) with ospemifene versus placebo at week 12. No unexpected TEAEs, treatment-related serious TEAEs, thrombotic events, or endometrial hyperplasia or carcinoma were observed. Ospemifene was effective and well tolerated for the treatment of moderate-to-severe Vaginal Dryness in postmenopausal women with VVA.

  • efficacy and safety of ospemifene in postmenopausal women with moderate to severe Vaginal Dryness a phase 3 randomized double blind placebo controlled multicenter trial
    Menopause, 2019
    Co-Authors: David F. Archer, Steven R. Goldstein, James A. Simon, Arthur Waldbaum, Steven A. Sussman, Corrado Altomare, Julie Zhu, Yuki Yoshida, Sam Schaffer, Graziella Soulban
    Abstract:

    AbstractObjective:To evaluate the safety and efficacy of ospemifene for the treatment of moderate to severe Vaginal Dryness in postmenopausal women with vulvoVaginal atrophy (VVA).Methods:This 12-week, multicenter, double-blind phase 3 study randomized postmenopausal women (aged 40-80 years) with VV

  • Efficacy of intraVaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and Vaginal Dryness, symptoms of vulvoVaginal atrophy, and of the genitourinary syndrome of menopause.
    Menopause, 2018
    Co-Authors: Fernand Labrie, David F. Archer, Isabelle Côté, Marlene Montesino, David J. Portman, William D. Koltun, Douglas Young, Andrée Vachon, Louise Frenette, Julie Parent
    Abstract:

    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). In a prospective, randomized, double-blind, and placebo-controlled phase III clinical trial, the effect of daily intraVaginal 0.50% DHEA (6.5 mg) (Prasterone, EndoCeutics) was examined on four coprimary objectives, namely percentage of parabasal cells, percentage or superficial cells, Vaginal pH, and moderate to severe pain at sexual activity (dyspareunia) identified by the women as their most bothersome vulvoVaginal atrophy symptom. The intent-to-treat population included 157 and 325 women in the placebo and DHEA-treated groups, respectively. After daily intraVaginal administration of 0.50% DHEA for 12 weeks, when compared to baseline by the analysis of covariance test, the percentage of parabasal cells decreased by 27.7% over placebo (P < 0.0001), whereas the percentage of superficial cells increased by 8.44% over placebo (P < 0.0001), Vaginal pH decreased by 0.66 pH unit over placebo (P < 0.0001), and pain at sexual activity decreased by 1.42 severity score unit from baseline or 0.36 unit over placebo (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 to the involved mechanisms of intracrinology. The only side effect reasonably related to treatment is Vaginal discharge due to melting of the vehicle at body temperature and this was reported in about 6% of the participants. The daily intraVaginal administration of 0.50% (6.5 mg) DHEA (Prasterone) has shown clinically and highly statistically significant effects on the four coprimary parameters suggested by the US Food and Drug Administration. The strictly local action of Prasterone is in line with the absence of significant drug-related adverse events, thus showing the high benefit-to-risk ratio of this treatment based upon the novel understanding of the physiology of sex steroids in women.

Sebastian Mirkin - One of the best experts on this subject based on the ideXlab platform.

James A. Simon - One of the best experts on this subject based on the ideXlab platform.

  • Ospemifene for the treatment of menopausal Vaginal Dryness, a symptom of the genitourinary syndrome of menopause.
    Expert review of endocrinology & metabolism, 2019
    Co-Authors: David F. Archer, Steven R. Goldstein, James A. Simon, David Portman, Irwin Goldstein
    Abstract:

    Introduction: VulvoVaginal atrophy (VVA), a component of the genitourinary syndrome of menopause, is a progressive condition due to decline in estrogen leading to Vaginal and vulvar epithelial changes. Accompanying symptoms of Dryness, irritation, burning, dysuria, and/or dyspareunia have a negative impact on quality of life. Ospemifene is a selective estrogen receptor modulator (SERM) approved by the FDA for moderate to severe dyspareunia and Vaginal Dryness due to postmenopausal VVA. Areas covered: PubMed was searched from inception to March 2019 with keywords ospemifene and vulvar Vaginal atrophy to review preclinical and clinical data describing the safety and efficacy of ospemifene for Vaginal Dryness and dyspareunia due to VVA. Covered topics include efficacy of ospemifene on Vaginal cell populations, Vaginal pH, and most bothersome VVA symptoms; imaging studies of vulvar and Vaginal tissues; effects on sexual function; and safety of ospemifene on endometrium, cardiovascular system, and breast. Expert opinion: Ospemifene is significantly more effective than placebo in all efficacy analyses studied, working through estrogen receptors and possibly androgen receptors. Safety as assessed by adverse events was generally comparable to that with placebo and to other SERMs, and/or adverse events were not clinically meaningful. No cases of endometrial or breast cancer were reported.

  • TX-004HR clinically improves symptoms of vulvar and Vaginal atrophy in postmenopausal women.
    Climacteric : the journal of the International Menopause Society, 2019
    Co-Authors: James A. Simon, David F. Archer, R Kagan, Ginger D. Constantine, Brian Bernick, S. Graham, Sebastian Mirkin
    Abstract:

    AbstractObjective: This study aimed to evaluate improvement of dyspareunia and associated Vaginal Dryness with a 17β-estradiol softgel Vaginal insert (TX-004HR; TherapeuticsMD, Boca Raton, FL, USA)...

  • Efficacy and safety of ospemifene in postmenopausal women with moderate-to-severe Vaginal Dryness: a phase 3, randomized, double-blind, placebo-controlled, multicenter trial
    Menopause (New York N.Y.), 2019
    Co-Authors: David F. Archer, Steven R. Goldstein, James A. Simon, Arthur Waldbaum, Steven A. Sussman, Corrado Altomare, Julie Zhu, Yuki Yoshida, Sam Schaffer, Graziella Soulban
    Abstract:

    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 years, a mean body mass index of 27.2 kg/m, and most were white. Ospemifene significantly improved (P < 0.0001) the percentages of parabasal and superficial cells, Vaginal pH, and severity of Vaginal Dryness severity compared with placebo at week 12; significant between-group differences were noted by week 4. Secondary endpoints of dyspareunia (P < 0.001), maturation value (P < 0.0001), and the Female Sexual Function Index (P < 0.05) also significantly improved with ospemifene versus placebo at week 12. Significantly more women responded (31.5% vs 6.0%; P < 0.0001) or were satisfied (49.2% vs 33.8%; P = 0.0007) with ospemifene versus placebo at week 12. No unexpected TEAEs, treatment-related serious TEAEs, thrombotic events, or endometrial hyperplasia or carcinoma were observed. Ospemifene was effective and well tolerated for the treatment of moderate-to-severe Vaginal Dryness in postmenopausal women with VVA.

  • efficacy and safety of ospemifene in postmenopausal women with moderate to severe Vaginal Dryness a phase 3 randomized double blind placebo controlled multicenter trial
    Menopause, 2019
    Co-Authors: David F. Archer, Steven R. Goldstein, James A. Simon, Arthur Waldbaum, Steven A. Sussman, Corrado Altomare, Julie Zhu, Yuki Yoshida, Sam Schaffer, Graziella Soulban
    Abstract:

    AbstractObjective:To evaluate the safety and efficacy of ospemifene for the treatment of moderate to severe Vaginal Dryness in postmenopausal women with vulvoVaginal atrophy (VVA).Methods:This 12-week, multicenter, double-blind phase 3 study randomized postmenopausal women (aged 40-80 years) with VV

  • Effects of ospemifene on genitourinary health assessed by prospective vulvar-vestibular photography and Vaginal/vulvar health indices.
    Menopause (New York N.Y.), 2019
    Co-Authors: Irwin Goldstein, James A. Simon, Corrado Altomare, Julie Zhu, Yuki Yoshida, Sam Schaffer, Andrew M. Kaunitz, Graziella Soulban
    Abstract:

    To prospectively evaluate the effects of ospemifene on the vulva and vagina in postmenopausal women using vulvar-vestibular photography and direct visual assessments. Postmenopausal women (aged 40-80 years) with moderate to severe Vaginal Dryness as their most bothersome symptom (MBS) were randomized to daily ospemifene 60 mg or placebo in this 12-week, multicenter, double-blind, phase 3 study. Vulvar-vestibular photographic images were captured at baseline and week 12 and were independently assessed with the Vulvar Imaging Assessment Scale (VIAS). Changes from baseline in Vaginal and Vulvar Health Indices (VHI and VuHI) with ospemifene versus placebo were analyzed at weeks 4, 8, and 12. Correlations between VIAS, VHI, and VuHI, with Vaginal Dryness severity and the Female Sexual Function Index (FSFI) scores were also assessed. In all, 631 eligible participants were randomized (ospemifene 316, placebo 315) and included in the intention-to-treat population. Compared with placebo, ospemifene significantly improved total scores for VIAS (P = 0.0154), VHI (P < 0.0001), and VuHI (P < 0.0001) from baseline to week 12; significant VHI (P < 0.0001) and VuHI (P = 0.002) improvements were observed at week 4. Most VHI and VuHI individual items were significantly better with ospemifene versus placebo at week 12 (P < 0.05). Most correlations between the vulvoVaginal assessment total scores versus Vaginal Dryness severity and FSFI scores were significant (P < 0.05). Improvements observed in vulvoVaginal health with ospemifene assessed by prospective vulvar-vestibular photography and other direct visual assessments support its efficacy in addition to the treatment of moderate to severe Vaginal Dryness due to menopause and the use of photographic and direct visual evaluations in future clinical trials. Supplemental Digital Content 1, http://links.lww.com/MENO/A415.

Hope S Rugo - One of the best experts on this subject based on the ideXlab platform.

  • 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
    JAMA Oncology, 2017
    Co-Authors: Michelle E Melisko, Mindy Goldman, Jimmy Hwang, Amy De Luca, Sally Fang, Amy Jo Chien, John W. Park, Laura J. Esserman, Hope S Rugo
    Abstract:

    Importance Aromatase inhibitors (AI) are associated with significant urogenital atrophy, affecting quality of life and drug compliance. Objective 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 (E 2 ), defined as E 2 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. Design, Setting, and Participants 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 Vaginal ring. Estradiol was measured at baseline and weeks 4 and 12 using a commercially available liquid chromatography and tandem mass spectrometry assay; follicle-stimulating hormone levels were measured at baseline and week 4. Gynecologic examinations and sexual quality-of-life questionnaires were completed at baseline and week 12. This randomized noncomparative design allowed safety evaluation of 2 interventions concurrently in the same population of patients, reducing the possibility of E 2 assay variability over time and between the 2 interventions. Main Outcomes and Measures The primary objective of this trial was to evaluate safety of IVT or an estradiol Vaginal ring in patients with early-stage BC receiving an AI; secondary objectives included evaluation of adverse events, changes in sexual quality of life using the Cancer Rehabilitation Evaluation System sexuality subscales, changes in Vaginal atrophy using a validated 4-point scale, and comparison of E 2 levels. Results Overall, 76 women signed consent (mean [range] age, 56 [37-78] years), 75 started treatment, and 69 completed 12 weeks of treatment. Mean (range) baseline E 2 was 20 ( 2 was above the postmenopausal range (>10 pg/mL) in 28 of 76 women (37%). Persistent E 2 elevation was observed in none with a Vaginal ring and in 4 of 34 women (12%) with IVT. Transient E 2 elevation was seen in 4 of 35 (11%) with a Vaginal ring and in 4 of 34 (12%) with IVT. Vaginal atrophy and sexual interest and dysfunction improved for all patients. Conclusions and Relevance In PM women with early-stage BC receiving AIs, treatment with a Vaginal ring or IVT over 12 weeks met the primary safety end point. Baseline elevation in E 2 was common and complicates this assessment. Vaginal atrophy, sexual interest, and sexual dysfunction were improved. Further study is required to understand E 2 variability in this setting. Trial Registration clinicaltrials.gov Identifier:NCT00698035

  • 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
    JAMA oncology, 2017
    Co-Authors: Michelle E Melisko, Mindy Goldman, Jimmy Hwang, Amy De Luca, Sally Fang, Amy Jo Chien, John W. Park, Laura J. Esserman, Hope S Rugo
    Abstract:

    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 Vaginal ring. Estradiol was measured at baseline and weeks 4 and 12 using a commercially available liquid chromatography and tandem mass spectrometry assay; follicle-stimulating hormone levels were measured at baseline and week 4. Gynecologic examinations and sexual quality-of-life questionnaires were completed at baseline and week 12. This randomized noncomparative design allowed safety evaluation of 2 interventions concurrently in the same population of patients, reducing the possibility of E2 assay variability over time and between the 2 interventions. The primary objective of this trial was to evaluate safety of IVT or an estradiol Vaginal ring in patients with early-stage BC receiving an AI; secondary objectives included evaluation of adverse events, changes in sexual quality of life using the Cancer Rehabilitation Evaluation System sexuality subscales, changes in Vaginal atrophy using a validated 4-point scale, and comparison of E2 levels. Overall, 76 women signed consent (mean [range] age, 56 [37-78] years), 75 started treatment, and 69 completed 12 weeks of treatment. Mean (range) baseline E2 was 20 (<2 to 127) pg/mL. At baseline, E2 was above the postmenopausal range (>10 pg/mL) in 28 of 76 women (37%). Persistent E2 elevation was observed in none with a Vaginal ring and in 4 of 34 women (12%) with IVT. Transient E2 elevation was seen in 4 of 35 (11%) with a Vaginal ring and in 4 of 34 (12%) with IVT. Vaginal atrophy and sexual interest and dysfunction improved for all patients. In PM women with early-stage BC receiving AIs, treatment with a Vaginal ring or IVT over 12 weeks met the primary safety end point. Baseline elevation in E2 was common and complicates this assessment. Vaginal atrophy, sexual interest, and sexual dysfunction were improved. Further study is required to understand E2 variability in this setting. clinicaltrials.gov Identifier: NCT00698035.

  • A Phase II Study of Vaginal Testosterone Cream (TEST) vs. Estring for Vaginal Dryness or Decreased Libido in Women with Early Stage Breast Cancer (BC) Treated with Aromatase Inhibitors (AIs).
    Poster Session Abstracts, 2009
    Co-Authors: Michelle E Melisko, Hope S Rugo, John W. Park, Amy N. Deluca, Mark M. Moasser, Pamela N. Munster, Matthew L. Goldman
    Abstract:

    Background: Sexual issues including Vaginal Dryness and decreased libido are common among breast cancer patients. Many interventions are hormonally based. The risk of these treatments is unknown and is of interest, particularly for patients with hormone receptor positive disease. Design: In a randomized open label study, we are evaluating the safety, based on serial measurements of serum estradiol (E) levels, of intraVaginal TEST or Estring used for 12 weeks (wks) for relief of Vaginal Dryness and/or decreased libido in women with early stage BC taking AIs. Planned enrollment is 35 patients (pts) per arm, and accrual will stop if a predetermined number of pts has a sustained elevation in serum E while on study. E is measured by an ultrasensensitive liquid chromatography-tandem mass spectrometry based assay. Eligible pts have not had a menstrual period for 12 months. and have taken an AI for at least one month. Pts who received chemotherapy or who are on ovarian suppression must have a serum E of 10 pg/ml or if there is a > 10 pg/ml elevation above their baseline value.Results: 29 pts have been enrolled; 15 to TEST, 14 to Estring. 20 pts have completed the 12 wk study period. Adverse events are rare and include grade 1 Vaginal discharge, odor, or burning, and hair growth. Two pts did not complete the study due to the Estring falling out. One pt discontinued Estring due to Vaginal discharge and irritation. One pt using TEST discontinued treatment due to a herpes outbreak. Among the Estring pts, two had an elevation in serum E to >10 pg/ml (14 pg/ml and 70 pg/ml) at wk 4 or at wk 12; but E returned to 10pg/ml at wk 4 or at wk 12; one remained modestly elevated (17 pg/ml) 4 wks later. Vaginal atrophy scores showed improvement in pts receiving both treatments, although the study is not powered to show a difference between the two arms.Conclusions: Both Vaginal TEST and Estring appear to be effective options to treat Vaginal Dryness in pts with early stage BC on AIs. The number of pts with sustained elevations in serum E levels to date has not reached the pre-defined threshold for stopping the study. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 5038.

Faina Linkov - One of the best experts on this subject based on the ideXlab platform.

  • assessment of hot flushes and Vaginal Dryness among obese women undergoing bariatric surgery
    Climacteric, 2016
    Co-Authors: Sharon L Goughnour, Rebecca C Thurston, Andrew D Althouse, Kyle E Freese, Robert P Edwards, Giselle G Hamad, Carol A Mccloskey, Ramesh C Ramanathan, Dana H Bovbjerg, Faina Linkov
    Abstract:

    ABSTRACTObjective 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.Methods 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.Results 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 in the prevalence of hot flushes or Vaginal Dryness in the overall study sample.Co...

  • Assessment of hot flushes and Vaginal Dryness among obese women undergoing bariatric surgery.
    Climacteric : the journal of the International Menopause Society, 2015
    Co-Authors: Sharon L Goughnour, Rebecca C Thurston, Andrew D Althouse, Kyle E Freese, Robert P Edwards, Giselle G Hamad, Carol A Mccloskey, Ramesh C Ramanathan, Dana H Bovbjerg, Faina Linkov
    Abstract:

    ABSTRACTObjective 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.Methods 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.Results The reported degree of bother of symptoms associated with hot flushes decreased from pre- to post-surgery (p 

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