Decreased efficacy of twice-weekly intravaginal dehydroepiandrosterone on vulvovaginal atrophy

Climacteric

Volumn 18, Issue 4, 2015, Pages 590-607

  Bouchard, C ^a   Labrie, F ^b   Archer, D F ^c   Portman, D J ^d   Koltun, W ^e   Elfassi, E ^f   Grainger, D A ^g   Ayotte, N ^h   Cooper, T A ⁱ   Martens, M ^j   Waldbaum, A S ^k   Labrie, C ^b   Cote I ^b   Lavoie, L ^b   Martel, C ^b   Balser, J ^l  

^a Clinique de Recherche en Sante des Femmes   (Canada)

^b Endoceutics Inc   (Canada)

^c EASTERN VIRGINIA MEDICAL SCHOOL   (United States)

^d Columbus Center for Women's Health Research ^*  (United States)

^e Medical Center for Clinical Research   (United States)

^f INSTITUTE FOR RESEARCH IN IMMUNOLOGY AND CANCER   (Canada)

^g Agronomic Services   (United States)

^h Clinique de Gynecologie   (Canada)

ⁱ Wind River Environmental Group   (United States)

^j JERSEY SHORE UNIVERSITY MEDICAL CENTER   (United States)

^k Downtown Women's Health Care   (United States)

^l Veristat   (United States)

more..

Author keywords

DHEA; low dosing; vulvovaginal atrophy

Indexed keywords

ESTRADIOL; PLACEBO; PRASTERONE; WITEPSOL; IMMUNOLOGICAL ADJUVANT;

ADULT; AGED; ARTICLE; COLOR; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DYSPAREUNIA; FEMALE; HUMAN; HUMAN CELL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THICKNESS; VAGINA ATROPHY; VAGINA DISCHARGE; VAGINA EPITHELIUM; VAGINA PH; VAGINAL DRYNESS; VAGINAL SECRETION; ATROPHY; CLINICAL TRIAL; COMPLICATION; DRUG ADMINISTRATION; INTRAVAGINAL DRUG ADMINISTRATION; MIDDLE AGED; MULTICENTER STUDY; POSTMENOPAUSE; TREATMENT OUTCOME; VAGINAL DISEASES; VULVAR DISEASES;

ADJUVANTS, IMMUNOLOGIC; ADMINISTRATION, INTRAVAGINAL; ADULT; AGED; ATROPHY; DEHYDROEPIANDROSTERONE; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DYSPAREUNIA; FEMALE; HUMANS; MIDDLE AGED; POSTMENOPAUSE; TREATMENT OUTCOME; VAGINAL DISEASES; VULVAR DISEASES;

EID: 84928079791     PISSN: 13697137     EISSN: 14730804     Source Type: Journal    
DOI: 10.3109/13697137.2014.992012     Document Type: Article

References (38)

1. Pines A, Sturdee DW, MacLennan AH, Schneider HP, Burger H, Fenton A. The heart of the WHI study: Time for hormone therapy policies to be revised. Climacteric 2007; 10: 267-9
2. Utian W H, Shoupe D, Bachmann G, Pinkerton J V, Pickar J H. Relief of vasomotor symptoms and vaginal atrophy with lower doses of conjugated equine estrogens and medroxyprogesterone acetate. Fertil Steril 2001; 75: 1065-79
3. Panay N, Kalu E. Management of premature ovarian failure. Best Pract Res Clin Obstet Gynaecol 2009; 23: 129-40
4. Archer DF. The gynecologic effects of lasofoxifene, an estrogen agonist/antagonist, in postmenopausal women. Menopause 2011; 18: 6-7
5. Labrie F, Cusan L, Gomez J L, et al. E ffect of one-week treatment with vaginal estrogen preparations on serum estrogen levels in postmenopausal women. Menopause 2009; 16: 30-6
6. Eugster-Hausmann M, Waitzinger J, Lehnick D. M inimized estradiol absorption with ultra-low-dose 10 g 17 -estradiol vaginal tablets. Climacteric 2010; 13: 219-27
7. Labrie F. DHEA after menopause-sole source of sex steroids and potential sex steroid deficiency treatment. Menopause Management 2010; 19: 14-24
8. Pandit L, Ouslander JG. Postmenopausal vaginal atrophy and atrophic vaginitis. Am J Med Sci 1997; 314: 228-31
9. The North American Menopause Society. T he role of local vaginal estrogen for treatment of vaginal atrophy in postmenopausal women: 2007 Position Statement of the North American Menopause Society. Menopause 2007; 14: 357-69
10. Bachmann G, Lobo RA, Gut R, Nachtigall L, Notelovitz M. Efficacy of low-dose estradiol vaginal tablets in the treatment of atrophic vaginitis: A randomized controlled trial. Obstet Gynecol 2008; 111: 67-76
11. Simon J, Nachtigall L, Gut R, Lang E, Archer D F, Utian W. Effective treatment of vaginal atrophy with an ultra-lowdose estradiol vaginal tablet. Obstet Gynecol 2008; 112: 1053-60
12. Labrie F. Intracrinology. Mol Cell Endocrinol 1991; 78: C113-18
13. Labrie F, Labrie C. DHEA and intracrinology at menopause, a positive choice for evolution of the human species. Climacteric 2013; 16: 205-13
14. Labrie F, Bé langer A, Cusan L, Gomez J L, Candas B. M arked decline in serum concentrations of adrenal C19 sex steroid precursors and conjugated androgen metabolites during aging. J Clin Endocrinol Metab 1997; 82: 2396-402
15. Labrie F, Bé langer A, Bé langer P, et a l. A ndrogen glucuronides, instead of testosterone, as the new markers of androgenic activity in women. J Steroid Biochem Mol Biol 2006; 99: 182-8
16. Labrie F. Drug Insight: breast cancer prevention and tissue-targeted hormone replacement therapy. Nature Clin Pract Endocrinol Metab 2007; 3: 584-93
17. Labrie F, Martel C, Balser J. Wide distribution of the serum dehydroepiandrosterone and sex steroid levels in postmenopausal women: role of the ovary? Menopause 2011; 18: 30-43
18. Labrie F, Archer D, Bouchard C, et al. I ntravaginal dehydroepiandrosterone (Prasterone), a physiological and highly efficient treatment of vaginal atrophy. Menopause 2009; 16: 907-22
19. Labrie F, Archer D, Bouchard C, et a l. I ntravaginal dehydroepiandrosterone (DHEA, Prasterone), a highly efficient treatment of dyspareunia. Climacteric 2011; 14: 282-
20. Bachmann G, Bouchard C, Hoppe D, et al. Efficacy and safety of low-dose regimens of conjugated estrogens cream administered vaginally. Menopause 2009; 16: 719-27
21. Davila GW, Singh A, Karapanagiotou I, et al. Are women with urogenital atrophy symptomatic? Am J Obstet Gynecol 2003; 188: 382-8
22. Guidance for Industry. Bioanalytical Method Validation, Revision
23. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM). Division of Drug Information, WO51, Room 2201, Center for Drug Evaluation and Research, Food and Drug Administration. http://wwwfdagov/ Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/defaulthtm. 2013
24. US Food and Drug Administration. Draft guidance for industry: estrogen and estrogen/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy symptoms-recommendations for clinical evaluation. http://wwwfdagov/downloads/ Drugs/DrugSafety/InformationbyDrugClass/UCM135338pdf. 2003
25. Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika 1988; 75: 800-2
26. Chen L, Ng MJ, van der Vlugt TH, Price PH, Orencia A. Statistical considerations for the efficacy assessment of clinical studies of vulvar and vaginal atrophy. Drug Information J 2010; 44: 581-8
27. Semmens JP, Wagner G. Estrogen deprivation and vaginal function in postmenopausal women. JAMA 1982; 248: 445-8
28. Santen RJ, Pinkerton JV, Conaway M, et al. Treatment of urogenital atrophy with low-dose estradiol: preliminary results. Menopause 2002; 9: 179-87
29. Rioux JE, Devlin C, Gelfand MM, Steinberg WM, Hepburn DS. 17beta-estradiol vaginal tablet versus conjugated equine estrogen vaginal cream to relieve menopausal atrophic vaginitis. Menopause 2000; 7: 156-61 Rigg
30. LA, Hermann H, Yen SS. Absorption of estrogens from vaginal creams. N Engl J Med 1978; 298: 195-7
31. Kicovic P M, Cortes-Prieto J, Milojevic S, Haspels A A, Aljinovic A. The treatment of postmenopausal vaginal atrophy with Ovestin vaginal cream or suppositories: clinical, endocrinological and safety aspects. Maturitas 1980; 2: 275-82
32. Hage J C, Benedek Jaszmann L J. A study of the effect of Premarin cream in the postmenopausal women. Cur Ther Res 1983; 33: 925-9
33. Mattsson LA, Cullberg G, Eriksson O, Knutsson F. Vaginal administration of low-dose oestradiol-effects on the endometrium and vaginal cytology. Maturitas 1989; 11: 217-22
34. Labrie F, Cusan L, Gomez JL, et al. Effect of intravaginal DHEA on serum DHEA and eleven of its metabolites in postmenopausal women. J Steroid Biochem Mol Biol 2008; 111: 178-94
35. Labrie F, Cusan L, Gomez J L, et al. C orrigendum to: Effect of intravaginal DHEA on serum DHEA and eleven of its metabolites in postmenopausal women. J Steroid Biochem Mol Biol 2008; 112: 169
36. Labrie F, Martel C, Berube R, et al. Intravaginal prasterone (DHEA) provides local action without clinically significant changes in serum concentrations of estrogens or androgens. J Steroid Biochem Mol Biol 2013; 138: 359-67
37. Naessen T, Berglund L, Ulmsten U. B one loss in elderly women prevented by ultralow doses of parenteral 17beta-estradiol. Am J Obstet Gynecol 1997; 177: 115-19
38. Naessen T, Rodriguez-Macias K, Lithell H. S erum lipid profile improved by ultra-low doses of 17 beta-estradiol in elderly women. J Clin Endocrinol Metab 2001; 86: 2757-62