113
Views
1
CrossRef citations to date
0
Altmetric
Menopause

Long-term use of ospemifene in clinical practice for vulvo-vaginal atrophy: end results at 12 months of follow-up

, , , , , & show all
Pages 577-582 | Received 11 Mar 2022, Accepted 23 May 2022, Published online: 07 Jun 2022

References

  • Bachmann GA, Komi JO, Ospemifene Study Group. Ospemifene study G. Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal phase 3 study. Menopause. 2010;17(3):480–486.
  • Portman DJ, Bachmann GA, Simon JA. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013;20(6):623–630.
  • Portman D, Palacios S, Nappi RE, et al. Ospemifene, a non-oestrogen selective oestrogen receptor modulator for the treatment of vaginal dryness associated with postmenopausal vulvar and vaginal atrophy: a randomised, placebo-controlled, phase III trial. Maturitas. 2014;78(2):91–98.
  • Pinkerton JV, Goldstein SR. Endometrial safety: a key hurdle for selective estrogen receptor modulators in development. Menopause. 2010;17(3):642–653.
  • Ibe C, Simon JA. Vulvovaginal atrophy: current and future therapies (CME). J Sex Med. 2010;7(3):1042–1050.
  • Simon JA, Lin VH, Radovich C, Ospemifene Study Group, et al. One-year long-term safety extension study of ospemifene for the treatment of vulvar and vaginal atrophy in postmenopausal women with a uterus. Menopause. 2013;20(4):418–427.
  • Constantine GD, Goldstein SR, Archer DF. Endometrial safety of ospemifene: results of the phase 2/3 clinical development program. Menopause. 2015;22(1):36–43.
  • Komi J, Heikkinen J, Rutanen EM, et al. Effects of ospemifene, a novel SERM, on biochemical markers of bone turnover in healthy postmenopausal women. Gynecol Endocrinol. 2004;18(3):152–158.
  • Komi J, Lankinen KS, DeGregorio M, et al. Effects of ospemifene and raloxifene on biochemical markers of bone turnover in postmenopausal women. J Bone Miner Metab. 2006;24(4):314–318.
  • Taras TL, Wurz GT, DeGregorio MW. In vitro and in vivo biologic effects of ospemifene (FC-1271a) in breast cancer. J Steroid Biochem Mol Biol. 2001;77(4–5):271–279.
  • Wurz GT, Read KC, Marchisano-Karpman C, et al. Ospemifene inhibits the growth of dimethylbenzanthracene-induced mammary tumors in Sencar mice. J Steroid Biochem Mol Biol. 2005;97(3):230–240.
  • Blonde L, Khunti K, Harris SB, et al. Interpretation and impact of real-world clinical data for the practicing clinician. Adv Ther. 2018;35(11):1763–1774.
  • Pingarrón C, de Lafuente P, Ierullo AM, et al. Ospemifene in clinical practice for vulvo-vaginal atrophy: results at 3 months of follow-up of use. Gynecol Endocrinol. 2021;37(6):562–566.
  • Pingarrón C, Lafuente P, Poyo Torcal S, et al. Vaginal health, endometrial thickness and changes in bone markers in postmenopausal women after 6 months of treatment with ospemifene in real clinical practice. Gynecol Endocrinol. 2021;38:78–82.
  • Asociación Española para el Estudio de la Menopausia. Menoguías para profesionales [cited 2022 Feb 23]. Available from: https://aeem.es/comunicacion/menoguias-para-profesionales/
  • Bachmann G. Urogenital ageing: an old problem newly recognized. Maturitas. 1995;22 (Suppl):S1–S5.
  • Sánchez F, Pérez Conchillo M, Borrás Valls JJ, et al. Design and validation of the questionnaire on women's sexual function (WSF). Aten Primaria. 2004;34(6):286–292.
  • Ruiz MA, Pardo A, Rejas J, et al. Development and validation of the "treatment satisfaction with medicines questionnaire" (SATMED-Q). Value Health. 2008;11(5):913–926.
  • Ettinger B, Black DM, Mitlak BH, et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple outcomes of raloxifene evaluation (MORE) investigators. JAMA. 1999;282(7):637–645.
  • Goldstein SR, Bachmann GA, Koninckx PR, Ospemifene Study Group, et al. Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy. Climacteric. 2014;17(2):173–182.
  • Simon J, Portman D, Mabey RG Jr, Ospemifene Study Group. Long-term safety of ospemifene (52-week extension) in the treatment of vulvar and vaginal atrophy in hysterectomized postmenopausal women. Maturitas. 2014;77(3):274–281.
  • Cui Y, Zong H, Yan H, et al. The efficacy and safety of ospemifene in treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy: a systematic review and meta-analysis. J Sex Med. 2014;11(2):487–497.
  • Constantine GD, 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.
  • Nappi RE, Mattsson LA, Lachowsky M, et al. The CLOSER survey: impact of postmenopausal vaginal discomfort on relationships between women and their partners in Northern and Southern Europe. Maturitas. 2013;75(4):373–379.
  • Sievert LL, Obermeyer CM, Saliba M. Symptom groupings at midlife: cross-cultural variation and association with job, home, and life change. Menopause. 2007;14(4):798–807.
  • 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.
  • Nappi RE, Palacios S, Panay N, et al. Vulvar and vaginal atrophy in four European countries: evidence from the European REVIVE survey. Climacteric. 2016;19(2):188–197.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.