Prasterone: A Review in Vulvovaginal Atrophy

Overview

Journal Drugs Aging

Specialties Geriatrics
Pharmacology

Date 2019 Jul 11

PMID 31290076

Citations 2

Authors

Young-A Heo

Affiliations

Soon will be listed here.

Abstract

Vulvovaginal atrophy (VVA) is a progressive condition commonly seen in postmenopausal women. The cessation of ovarian estrogen secretion and a fall in serum levels of dehydroepiandrosterone (DHEA), the remaining source of estrogens and androgens, are thought to promote the development of VVA in this population. Intravaginal prasterone (Intrarosa) is a synthetic form of DHEA indicated for the treatment of VVA in postmenopausal women presenting with moderate to severe symptoms in the EU; prasterone is also approved in the USA for the treatment of dyspareunia due to menopause. Approval for the treatment of VVA was based on the results of the phase III ERC-231 and -238 trials in which intravaginal prasterone 6.5 mg/day significantly improved the signs and symptoms of VVA (as assessed by the percentage of parabasal and superficial cells, vaginal pH and the severity of dyspareunia) compared with placebo. The beneficial effects of prasterone were also evident during 52 weeks' treatment in the phase III ERC-230 safety trial. Prasterone was generally well tolerated, with the most common treatment-emergent adverse event being application site discharge. During 52 weeks of treatment with prasterone, changes in serum concentrations of estrogenic and androgenic metabolites of DHEA increased from baseline but remained within the normal postmenopausal ranges. Thus, intravaginal prasterone is an effective and generally well-tolerated option for the treatment of VVA in postmenopausal women.

Citing Articles

Management of Hypertension with Female Sexual Dysfunction.

Zhong Q, Anderson Y Medicina (Kaunas). 2022; 58(5).

PMID: 35630054 PMC: 9143081. DOI: 10.3390/medicina58050637.

Position statement by Experts of the Polish Menopause and Andropause Society, and the Polish Society of Aesthetic and Reconstructive Gynaecology on the medicinal product Intrarosa.

Binkowska M, Paszkowski T, Violetta S, Wilczak M, Zgliczynski W Prz Menopauzalny. 2020; 18(3):127-132.

PMID: 31975978 PMC: 6970414. DOI: 10.5114/pm.2019.90113.

References

Nappi R, Kokot-Kierepa M . Women's voices in the menopause: results from an international survey on vaginal atrophy. Maturitas. 2010; 67(3):233-8. DOI: 10.1016/j.maturitas.2010.08.001. View

. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2017; 24(7):728-753. DOI: 10.1097/GME.0000000000000921. View

Portman D, Labrie F, Archer D, Bouchard C, Cusan L, Girard G . Lack of effect of intravaginal dehydroepiandrosterone (DHEA, prasterone) on the endometrium in postmenopausal women. Menopause. 2015; 22(12):1289-95. DOI: 10.1097/GME.0000000000000470. View

Labrie F, Belanger A, Pelletier G, Martel C, Archer D, Utian W . Science of intracrinology in postmenopausal women. Menopause. 2017; 24(6):702-712. DOI: 10.1097/GME.0000000000000808. View

Martel C, Labrie F, Archer D, Ke Y, Gonthier R, Simard J . Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks. J Steroid Biochem Mol Biol. 2016; 159:142-53. DOI: 10.1016/j.jsbmb.2016.03.016. View

Neves-E-Castro M, Birkhauser M, Samsioe G, Lambrinoudaki I, Palacios S, Sanchez Borrego R . EMAS position statement: The ten point guide to the integral management of menopausal health. Maturitas. 2015; 81(1):88-92. DOI: 10.1016/j.maturitas.2015.02.003. View

Labrie F, Archer D, Bouchard C, Girard G, Ayotte N, Gallagher J . Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy: 52-week open-label study. Maturitas. 2015; 81(1):46-56. DOI: 10.1016/j.maturitas.2015.02.005. View

Naumova I, Castelo-Branco C . Current treatment options for postmenopausal vaginal atrophy. Int J Womens Health. 2018; 10:387-395. PMC: 6074805. DOI: 10.2147/IJWH.S158913. View

Archer D, Labrie F, Bouchard C, Portman D, Koltun W, Cusan L . Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone). Menopause. 2015; 22(9):950-63. DOI: 10.1097/GME.0000000000000428. View

10.

Bouchard C, Labrie F, DeRogatis L, Girard G, Ayotte N, Gallagher J . Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study. Horm Mol Biol Clin Investig. 2016; 25(3):181-90. DOI: 10.1515/hmbci-2015-0044. View

11.

Labrie F . All sex steroids are made intracellularly in peripheral tissues by the mechanisms of intracrinology after menopause. J Steroid Biochem Mol Biol. 2014; 145:133-8. DOI: 10.1016/j.jsbmb.2014.06.001. View

12.

Berger L, El-Alfy M, Labrie F . Effects of intravaginal dehydroepiandrosterone on vaginal histomorphology, sex steroid receptor expression and cell proliferation in the rat. J Steroid Biochem Mol Biol. 2008; 109(1-2):67-80. DOI: 10.1016/j.jsbmb.2007.09.023. View

13.

Stuenkel C, Santen R . An introduction to the Endocrine Society Clinical Practice Guideline on treatment of symptoms of the menopause. Post Reprod Health. 2016; 22(1):6-8. DOI: 10.1177/2053369115626029. View

14.

Labrie F, DeRogatis L, Archer D, Koltun W, Vachon A, Young D . Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2015; 12(12):2401-12. DOI: 10.1111/jsm.13045. View

15.

Labrie F, Archer D, Koltun W, Vachon A, Young D, Frenette L . 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. 2016; 23(3):243-56. DOI: 10.1097/GME.0000000000000571. View

16.

Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez J . Intravaginal dehydroepiandrosterone (prasterone), a highly efficient treatment of dyspareunia. Climacteric. 2011; 14(2):282-8. DOI: 10.3109/13697137.2010.535226. View

17.

Nappi R, Kokot-Kierepa M . Vaginal Health: Insights, Views & Attitudes (VIVA) - results from an international survey. Climacteric. 2011; 15(1):36-44. DOI: 10.3109/13697137.2011.647840. View

18.

Santen R . Vaginal administration of estradiol: effects of dose, preparation and timing on plasma estradiol levels. Climacteric. 2014; 18(2):121-34. DOI: 10.3109/13697137.2014.947254. View

19.

Berger L, El-Alfy M, Martel C, Labrie F . Effects of dehydroepiandrosterone, Premarin and Acolbifene on histomorphology and sex steroid receptors in the rat vagina. J Steroid Biochem Mol Biol. 2005; 96(2):201-15. DOI: 10.1016/j.jsbmb.2005.02.018. View

20.

Archer D, Labrie F, Montesino M, Martel C . Comparison of intravaginal 6.5mg (0.50%) prasterone, 0.3mg conjugated estrogens and 10μg estradiol on symptoms of vulvovaginal atrophy. J Steroid Biochem Mol Biol. 2017; 174:1-8. DOI: 10.1016/j.jsbmb.2017.03.014. View