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Climacteric Volume 26, 2023 - Issue 5
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Original Articles

Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVA1: a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy

A. Thurmana Daré Bioscience, Inc., San Diego, CA, USACorrespondence[email protected]
,
L. Hullb PARC Clinical Research and Robinson Research Institute, University of Adelaide, Adelaide, SA, Australia
,
B. Stuckeyc Keogh Institute for Medical Research, Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, University of Western Australia, Nedlands, WA, Australia
,
J. Hathewaya Daré Bioscience, Inc., San Diego, CA, USA
,
C. Maucka Daré Bioscience, Inc., San Diego, CA, USA
,
N. Zacka Daré Bioscience, Inc., San Diego, CA, USA
&
D. Frienda Daré Bioscience, Inc., San Diego, CA, USA
 show all
Pages 479-488 | Received 20 Mar 2023, Accepted 01 May 2023, Published online: 08 Jun 2023

References

  • Portman DJ, Gass ML. Vulvovaginal atrophy terminology consensus conference P. 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. Maturitas. 2014;79(3):349–354.
  • Gandhi J, Chen A, Dagur G, et al. Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management. Am J Obstet Gynecol. 2016;215(6):704–711.
  • Benini V, Ruffolo AF, Casiraghi A, et al. New innovations for the treatment of vulvovaginal atrophy: an up-to-Date review. Medicina. 2022;58(6):770.
  • Santoro N, Komi J. Prevalence and impact of vaginal symptoms among postmenopausal women. J Sex Med. 2009;6(8):2133–2142.
  • Suckling J, Lethaby A, Kennedy R. Local oestrogen for vaginal atrophy in postmenopausal women. Cochrane Database Syst Rev. 2006;8(4):CD001500.
  • Biglia N, Bounous VE, D’Alonzo M, et al. Vaginal atrophy in breast cancer survivors: attitude and approaches among oncologists. Clin Breast Cancer. 2017;17(8):611–617.
  • Duchesnay. Approved Labeling Osphena Tablets. https://wwwaccessdatafdagov/drugsatfda_docs/label/2019/203505s015lblpdf. 2019.
  • Pinkerton JV, Stanczyk FZ. Clinical effects of selective estrogen receptor modulators on vulvar and vaginal atrophy. Menopause. 2014;21(3):309–319.
  • Ferrazzi E, Cartei G, Mattarazzo R, et al. Oestrogen-like effect of tamoxifen on vaginal epithelium. Br Med J. 1977;1(6072):1351–1352.
  • Boccardo F, Bruzzi P, Rubagotti A, et al. Estrogen-like action of tamoxifen on vaginal epithelium in breast cancer patients. Oncology. 1981;38(5):281–285.
  • Miodrag A, Ekelund P, Burton R, et al. Tamoxifen and partial oestrogen agonism in postmenopausal women. Age Ageing. 1991;20(1):52–54.
  • Lahti E, Vuopala S, Kauppila A, et al. Maturation of vaginal and endometrial epithelium in postmenopausal breast cancer patients receiving long-term tamoxifen. Gynecol Oncol. 1994;55(3 Pt 1):410–414.
  • Love RR, Kurtycz DF, Dumesic DA, et al. The effects of tamoxifen on the vaginal epithelium in postmenopausal women. J Womens Health Gend Based Med. 2000;9(5):559–563.
  • Shiota A, Igarashi T, Kurose T, et al. Reciprocal effects of tamoxifen on hormonal cytology in postmenopausal women. Acta Cytol. 2002;46(3):499–506.
  • Vardy MD, Lindsay R, Scotti RJ, et al. Short-term urogenital effects of raloxifene, tamoxifen, and estrogen. Am J Obstet Gynecol. 2003;189(1):81–88.
  • Wardell SE, Nelson ER, McDonnell DP. From empirical to mechanism-based discovery of clinically useful selective estrogen receptor modulators (SERMs). Steroids. 2014;90:30–38.
  • Jordan VC. Tamoxifen: a most unlikely pioneering medicine. Nat Rev Drug Discov. 2003;2(3):205–213.
  • Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for the prevention of breast cancer: current status of the national surgical adjuvant breast and bowel project P-1 study. J Natl Cancer Inst. 2005;97(22):1652–1662.
  • Astra Zenaca. Approved Labeling for Nolvadex (Tamoxifen Citrate Tablets) NDA 017970. https://wwwaccessdatafdagov/drugsatfda_docs/label/2005/17970s053lblpdf. 2009.
  • Jordan VC. New insights into the metabolism of tamoxifen and its role in the treatment and prevention of breast cancer. Steroids. 2007;72(13):829–842.
  • Fan EM, Zimmern PE. Challenges of managing lower urinary tract symptoms in women with tamoxifen use. Womens Health Rep. 2022;3(1):430–436.
  • Kallak TK, Baumgart J, Goransson E, et al. Aromatase inhibitors affect vaginal proliferation and steroid hormone receptors. Menopause. 2014;21(4):383–390.
  • Faubion SS, Larkin LC, Stuenkel CA, et al. Management of genitourinary syndrome of menopause in women with or at high risk for breast cancer: consensus recommendations from the North American menopause society and the international society for the study of women’s sexual health. Menopause. 2018;25(6):596–608.
  • Nappi RE, Kokot-Kierepa M. Vaginal health: insights, views & attitudes (VIVA) – results from an international survey. Climacteric. 2012;15(1):36–44.
  • Chollet J, Mermelstein F, Rocamboli SC, et al. Vaginal tamoxifen for treatment of vulvar and vaginal atrophy: pharmacokinetics and local tolerance in a rabbit model over 28 days. Int J Pharm. 2019;570:118691.
  • ACOG committee opinion no. 601: tamoxifen and uterine cancer. Obstet Gynecol. 2014;123(6):1394–1397.
  • Wickerham DL, Costantino JP, Vogel VG, et al. The use of tamoxifen and raloxifene for the prevention of breast cancer. Recent Results Cancer Res. 2009;181:113–119.
  • Wickerham DL, O’Connell MJ, Costantino JP, et al. The half century of clinical trials of the national surgical adjuvant breast and bowel project. Semin Oncol. 2008;35(5):522–529.

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