Effects of vaginal estradiol tablets and moisturizer on menopause-specific quality of life and mood in healthy postmenopausal women with vaginal symptoms: A randomized clinical trial

Susan J Diem, Katherine A. Guthrie, Caroline M. Mitchell, Susan D. Reed, Joseph C. Larson, Kristine E Ensrud, Andrea Z. Lacroix

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Objective: Compare the effects of a vaginal estradiol tablet and a vaginal moisturizer, each to placebo, on menopause-related quality of life and mood in postmenopausal women with moderate-severe vulvovaginal symptoms. Methods: A total of 302 postmenopausal women enrolled in a 12-week, double-blind, placebo-controlled randomized trial were assigned to vaginal 10 mg estradiol tablet plus placebo gel (n1/4102), vaginal moisturizer plus placebo tablet (n1/4100), or dual placebo (n1/4100). We measured change from randomization to 12 weeks in total score of the Menopause-Specific Quality of Life (MENQOL) questionnaire. We also evaluated the four MENQOL domains, depressive symptoms as measured by the Patient Health Questionnaire 8, and anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7) questionnaire. Results: Treatment with vaginal estradiol resulted in significantly greater improvement in total MENQOL scores compared to dual placebo (mean difference between arms 0.3 at 12 weeks (95% confidence interval [CI] 0.5, 0.0; P1/40.01). A statistically significant group mean difference favoring vaginal estradiol was observed for the MENQOL sexual function domain (0.4 at 12 weeks; 95% CI 1.0, 0.1; P1/40.005), but not for any of the other domains. Treatment with vaginal moisturizer did not provide greater improvement compared to placebo in total MENQOL scores (mean difference 0.2 at 12 weeks; 95% CI 0.1, 0.4; P1/40.38) or in any of the MENQOL domains. Neither treatment group showed improvement compared with placebo in the Patient Health Questionnaire 8 or Generalized Anxiety Disorder Questionnaire . Conclusions: Treatment with low-dose vaginal estradiol, but not vaginal moisturizer, modestly improved menopause-related quality of life and sexual function domain scores in postmenopausal women with moderate- severe vulvovaginal symptoms.

Original languageEnglish (US)
Pages (from-to)1086-1093
Number of pages8
JournalMenopause
Volume25
Issue number10
DOIs
StatePublished - Jan 1 2018

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Foams and Jellies Vaginal Creams
Menopause
Estradiol
Randomized Controlled Trials
Placebos
Quality of Life
Confidence Intervals
Anxiety Disorders
Tablets
Health
Therapeutics
Random Allocation
Anxiety
Gels
Surveys and Questionnaires
Depression

Keywords

  • Anxiety
  • Clinical trials network
  • Depressive symptoms
  • Postmenopausal vulvovaginal symptoms
  • Quality of life
  • Vaginal estrogen
  • Vaginal moisturizer

PubMed: MeSH publication types

  • Journal Article
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

Cite this

Effects of vaginal estradiol tablets and moisturizer on menopause-specific quality of life and mood in healthy postmenopausal women with vaginal symptoms : A randomized clinical trial. / Diem, Susan J; Guthrie, Katherine A.; Mitchell, Caroline M.; Reed, Susan D.; Larson, Joseph C.; Ensrud, Kristine E; Lacroix, Andrea Z.

In: Menopause, Vol. 25, No. 10, 01.01.2018, p. 1086-1093.

Research output: Contribution to journalArticle

Diem, Susan J ; Guthrie, Katherine A. ; Mitchell, Caroline M. ; Reed, Susan D. ; Larson, Joseph C. ; Ensrud, Kristine E ; Lacroix, Andrea Z. / Effects of vaginal estradiol tablets and moisturizer on menopause-specific quality of life and mood in healthy postmenopausal women with vaginal symptoms : A randomized clinical trial. In: Menopause. 2018 ; Vol. 25, No. 10. pp. 1086-1093.
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abstract = "Objective: Compare the effects of a vaginal estradiol tablet and a vaginal moisturizer, each to placebo, on menopause-related quality of life and mood in postmenopausal women with moderate-severe vulvovaginal symptoms. Methods: A total of 302 postmenopausal women enrolled in a 12-week, double-blind, placebo-controlled randomized trial were assigned to vaginal 10 mg estradiol tablet plus placebo gel (n1/4102), vaginal moisturizer plus placebo tablet (n1/4100), or dual placebo (n1/4100). We measured change from randomization to 12 weeks in total score of the Menopause-Specific Quality of Life (MENQOL) questionnaire. We also evaluated the four MENQOL domains, depressive symptoms as measured by the Patient Health Questionnaire 8, and anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7) questionnaire. Results: Treatment with vaginal estradiol resulted in significantly greater improvement in total MENQOL scores compared to dual placebo (mean difference between arms 0.3 at 12 weeks (95{\%} confidence interval [CI] 0.5, 0.0; P1/40.01). A statistically significant group mean difference favoring vaginal estradiol was observed for the MENQOL sexual function domain (0.4 at 12 weeks; 95{\%} CI 1.0, 0.1; P1/40.005), but not for any of the other domains. Treatment with vaginal moisturizer did not provide greater improvement compared to placebo in total MENQOL scores (mean difference 0.2 at 12 weeks; 95{\%} CI 0.1, 0.4; P1/40.38) or in any of the MENQOL domains. Neither treatment group showed improvement compared with placebo in the Patient Health Questionnaire 8 or Generalized Anxiety Disorder Questionnaire . Conclusions: Treatment with low-dose vaginal estradiol, but not vaginal moisturizer, modestly improved menopause-related quality of life and sexual function domain scores in postmenopausal women with moderate- severe vulvovaginal symptoms.",
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AU - Guthrie, Katherine A.

AU - Mitchell, Caroline M.

AU - Reed, Susan D.

AU - Larson, Joseph C.

AU - Ensrud, Kristine E

AU - Lacroix, Andrea Z.

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N2 - Objective: Compare the effects of a vaginal estradiol tablet and a vaginal moisturizer, each to placebo, on menopause-related quality of life and mood in postmenopausal women with moderate-severe vulvovaginal symptoms. Methods: A total of 302 postmenopausal women enrolled in a 12-week, double-blind, placebo-controlled randomized trial were assigned to vaginal 10 mg estradiol tablet plus placebo gel (n1/4102), vaginal moisturizer plus placebo tablet (n1/4100), or dual placebo (n1/4100). We measured change from randomization to 12 weeks in total score of the Menopause-Specific Quality of Life (MENQOL) questionnaire. We also evaluated the four MENQOL domains, depressive symptoms as measured by the Patient Health Questionnaire 8, and anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7) questionnaire. Results: Treatment with vaginal estradiol resulted in significantly greater improvement in total MENQOL scores compared to dual placebo (mean difference between arms 0.3 at 12 weeks (95% confidence interval [CI] 0.5, 0.0; P1/40.01). A statistically significant group mean difference favoring vaginal estradiol was observed for the MENQOL sexual function domain (0.4 at 12 weeks; 95% CI 1.0, 0.1; P1/40.005), but not for any of the other domains. Treatment with vaginal moisturizer did not provide greater improvement compared to placebo in total MENQOL scores (mean difference 0.2 at 12 weeks; 95% CI 0.1, 0.4; P1/40.38) or in any of the MENQOL domains. Neither treatment group showed improvement compared with placebo in the Patient Health Questionnaire 8 or Generalized Anxiety Disorder Questionnaire . Conclusions: Treatment with low-dose vaginal estradiol, but not vaginal moisturizer, modestly improved menopause-related quality of life and sexual function domain scores in postmenopausal women with moderate- severe vulvovaginal symptoms.

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KW - Vaginal estrogen

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