2,303
Views
3
CrossRef citations to date
0
Altmetric
Review

Estradiol softgel inserts for the treatment of VVA symptoms: an expert opinion

, &
Pages 1573-1581 | Received 22 May 2020, Accepted 12 Aug 2020, Published online: 02 Sep 2020

References

  • Santoro N, Komi J. Prevalence and impact of vaginal symptoms among postmenopausal women. J Sex Med. 2009;6(8):2133–2142.
  • Simon JA, Kokot-Kierepa M, Goldstein J, et al. Vaginal health in the United States: results from the Vaginal Health: insights, views & attitudes survey. Menopause. 2013;20(10):1043–1048.
  • Gass ML, Cochrane BB, Larson JC, et al. Patterns and predictors of sexual activity among women in the hormone therapy trials of the women’s health initiative. Menopause. 2011;18(11):1160–1171.
  • Portman DJ, Gass ML. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the international society for the study of women’s sexual health and the North American Menopause Society. Menopause. 2014;21(10):1063–1068.
  • Kingsberg SA, Wysocki S, Magnus L, et al. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal women’s views of treatment options for menopausal vaginal ChangEs) survey. J Sex Med. 2013;10(7):1790–1799.
  • The North American Menopause Society. Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American menopause society. Menopause. 2013;20(9):888–902.
  • Simon JA, Nappi RE, Kingsberg SA, et al. Clarifying vaginal atrophy’s impact on sex and relationships (CLOSER) survey: emotional and physical impact of vaginal discomfort on North American postmenopausal women and their partners. Menopause. 2014;21(2):137–142.
  • Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the women’s health initiative randomized controlled trial. JAMA. 2002;288(3):321–333.
  • Tsai SA, Stefanick ML, Stafford RS. Trends in menopausal hormone therapy use of US office-based physicians, 2000-2009. Menopause. 2011;18(4):385–392.
  • Alexander NJ, Baker E, Kaptein M, et al. Why consider vaginal drug administration? Fertil Steril. 2004;82(1):1–12.
  • Cicinelli E. Intravaginal oestrogen and progestin administration: advantages and disadvantages. Best Pract Res Clin Obstet Gynaecol. 2008;22(2):391–405.
  • Santen RJ, Mirkin S, Bernick B, et al. Systemic estradiol levels with low-dose vaginal estrogens. Menopause. 2020;27(3):361–370.
  • Constantine GD, Graham S, Lapane K, et al. Endometrial safety of low-dose vaginal estrogens in menopausal women: a systematic evidence review. Menopause. 2019;26(7):800–807.
  • Imvexxy (estradiol vaginal inserts) Prescribing Information. Boca Raton, FL: TherapeuticsMD; 2018.
  • Simon JA, Pickar JH, Shadiack AM, et al. Physical characteristics and properties of estradiol softgel vaginal inserts. Menopause. 2020;27(2):150–155.
  • Constantine G, Simon JA, Pickar JH, et al. The REJOICE trial: a phase 3 randomized, controlled trial evaluating the safety and efficacy of a novel vaginal estradiol soft-gel capsule for symptomatic vulvar and vaginal atrophy. Menopause. 2017;24(4):409–416.
  • Pickar JH, Amadio JM, Hill JM, et al. A randomized, double-blind, placebo-controlled phase 2 pilot trial evaluating a novel, vaginal softgel capsule containing solubilized estradiol. Menopause. 2016;23(5):506–510.
  • Simon JA, Archer DF, Constantine GD, et al. A vaginal estradiol softgel capsule, TX-004HR, has negligible to very low systemic absorption of estradiol: efficacy and pharmacokinetic data review. Maturitas. 2017;99:51–58.
  • Simon JA, Kagan R, Archer DF, et al. TX-004HR clinically improves symptoms of vulvar and vaginal atrophy in postmenopausal women. Climacteric. 2019;22(4):412–418.
  • Constantine GD, Bouchard C, Pickar JH, et al. 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. J Womens Health (Larchmt). 2017;26(6):616–623.
  • Constantine G, Millheiser LS, Kaunitz AM, et al. Early onset of action with a 17β-estradiol, softgel, vaginal insert for treating vulvar and vaginal atrophy and moderate to severe dyspareunia. Menopause. 2019;26(11):1259–1264.
  • Simon JA, Archer DF, Kagan R, et al. Visual improvements in vaginal mucosa correlate with symptoms of VVA: data from a double-blind, placebo-controlled trial. Menopause. 2017;24(9):1003–1010. *Phase 3 trial showing visual improvements in the vaginal mucosa with the softgel vaginal estradiol inserts.
  • Kingsberg S, Derogatis L, Simon JA, et al. TX-004HR improves sexual function as measured by the female sexual function index in postmenopausal women with vulvovaginal vulvar and vaginal atrophy: the REJOICE Trial. J Sex Med. 2016;13(12):1930–1937.
  • Rosen R, Brown C, Heiman J, et al. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26(2):191–208.
  • Minkin MJ, Maamari R, Reiter S. Improved compliance and patient satisfaction with estradiol vaginal tablets in postmenopausal women previously treated with another local estrogen therapy. Int J Womens Health. 2013;5:133–139.
  • Minkin MJ, Maamari R, Reiter S. Postmenopausal vaginal atrophy: evaluation of treatment with local estrogen therapy. Int J Womens Health. 2014;6:281–288.
  • Wysocki S, Kingsberg S, Krychman M. Management of vaginal atrophy: implications from the REVIVE study. Clin Med Insights Reprod Health. 2014;8:23–30.
  • Kingsberg S, Krychman M, Graham S, et al. The Women’s EMPOWER Survey: identifying women’s perceptions on vulvar and vaginal atrophy (VVA) and its treatment. J Sex Med. 2017;14(3):413–424.
  • Portman D, Shulman L, Yeaw J, et al. One-year treatment persistence with local estrogen therapy in postmenopausal women diagnosed as having vaginal atrophy. Menopause. 2015;22:1197–1203.
  • Kingsberg S, Kroll R, Goldstein I, et al. Patient acceptability and satisfaction with a low-dose solubilized vaginal estradiol softgel capsule, TX-004HR. Menopause. 2017;24(8):894–899.
  • Pickar JH, Amadio JM, Bernick BA, et al. Pharmacokinetic studies of solubilized estradiol given vaginally in a novel softgel capsule. Climacteric. 2016;19(2):181–187.
  • Archer DF, Constantine GD, Simon J, et al. TX-004HR vaginal estradiol has negligible to very low systemic absorption of estradiol. Menopause. 2017;24(5):510–516.
  • Muzny CA, Schwebke JR. Biofilms: an Underappreciated Mechanism of Treatment Failure and Recurrence in Vaginal Infections. Clin Infect Dis. 2015;61(4):601–606.
  • Hardy L, Jespers V, De Baetselier I, et al. The impact of vaginal bacterial biofilm on intravaginal rings. Sex Transm Infect. 2015;91:A53–A54.
  • de Araujo Pereira RR, Bruschi ML. Vaginal mucoadhesive drug delivery systems. Drug Dev Ind Pharm. 2012;38(6):643–652.
  • Sohi H, Ahuja A, Ahmad FJ, et al. Critical evaluation of permeation enhancers for oral mucosal drug delivery. Drug Dev Ind Pharm. 2010;36(3):254–282.
  • Baumgart J, Nilsson K, Evers AS, et al. Sexual dysfunction in women on adjuvant endocrine therapy after breast cancer. Menopause. 2013;20(2):162–168.
  • Cella D, Fallowfield L, Barker P, et al. Quality of life of postmenopausal women in the ATAC (“arimidex”, tamoxifen, alone or in combination) trial after completion of 5 years’ adjuvant treatment for early breast cancer. Breast Cancer Res Treat. 2006;100(3):273–284.
  • Fallowfield L, Cella D, Cuzick J, et al. Quality of life of postmenopausal women in the Arimidex, Tamoxifen, Alone or in Combination (ATAC) Adjuvant Breast Cancer Trial. J Clin Oncol. 2004;22(21):4261–4271.
  • American College of Obstetricians and Gynecologists. The use of vaginal estrogen in women with a history of estrogen-dependent breast cancer. Committee Opinion No. 659. Obstet Gynecol. 2016;127(3):e93–96.
  • Vagifem® (estradiol vaginal tablets) prescribing information. Plainsboro, NJ: Novo Nordisk Pharmaceuticals Inc; 2017.
  • Estrace® cream (estradiol vaginal cream, USP, 0.01%) prescribing information. Madison, NJ: Allergan USA, Inc; 2018.
  • Premarin® (conjugated estrogens) vaginal cream prescribing information. Philadelphia, PA: Wyeth Pharmaceuticals Inc; 2018.
  • Estring® (estradiol vaginal ring) prescribing information. NY: Pharmacia & Upjohn Company, Division of Pfizer Inc; 2013.