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#237 Verifying the value of vaginal estradiol tablets

Are vaginal estradiol tablets (Vagifem®) effective for genitourinary syndrome of menopause?

Vaginal estradiol tablets are likely no better than placebo vaginal gel for reducing “most bothersome symptom scores” (mainly dyspareunia). However, compared to placebo vaginal tablets, they reduce symptoms (example: treatment “success” at 12 months in 86% versus 41% placebo). A non-medicated vaginal gel may be reasonable first-line for dyspareunia.

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Six double-blind, placebo-controlled, randomized, controlled trials (RCTs). Most used 4-point outcome scale (range 0-3, lower better).1-4 Statistically significant unless indicated.  Versus placebo gel: 
  • 1 RCT (302 women). Most bothersome symptom score (pain with vaginal penetration in 60%). Final score at 12 weeks (baseline 2.5): 
    • 1.1 versus 1.2 (placebo), not statistically different.1 
    • "Meaningful benefit": 80% versus 65% (placebo). 
    • No difference: 11 other outcomes. 
Versus placebo vaginal tablet: 
  • Vaginal symptoms: 
    • Most bothersome symptom score (dyspareunia in 57%). Final score at 12 weeks (baseline ~2.3): 
      • 1 RCT (309 women): 1.1 versus 1.4 (placebo).2 
    • Composite vaginal symptom score (baseline ~2), final score: 
      • At 12 months (1612 women): 0.21 versus 1.15 (placebo).3 
      • At 12 weeks (230 women):4 
        • 25mcg dose 0.56 versus 1.1 (placebo). 
        • 10mcg dose not different from placebo. 
    • Percent without moderate-severe individual symptoms at 12 weeks (1 RCT, 164 women):5 
      • Dryness: 85% versus 72% (placebo). 
      • Itching/burning: 89% versus 74% (placebo), not statistically different. 
      • Dyspareunia: 92% versus 76% (placebo). 
    • Overall "success" at 12 months (1612 women):3 86% versus 41% (placebo), number needed to treat=3. 
  • Urinary incontinence:  
    • Percent without urinary symptoms: 
      • At 12 months (1612 women): 84% versus 64% (placebo).3 
      •  “Change for the better”:  
        • At 12 weeks (164 women): 63% versus 32% placebo.5 
      • No difference frequency/nocturia at 12 weeks (110 women).6 
    • Cancer/endometrial thickening (unopposed estrogen), 2 industry-funded studies:7,8 
      • From 386 women with negative baseline investigations, 1 hyperplasia and 1 carcinoma.
        • Similar to background rate. 
  • Systematic reviews combined different dosage forms and did not include all RCTs.9-12 
  • Some studies used 25mcg dose, not available in Canada.3-6 
  • Vaginal moisturizer no better than placebo gel.1 
  • More women satisfied with tablets than vaginal estrogen cream (85% versus 73%).13

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  • Adrienne J Lindblad BSP ACPR PharmD
  • Mark Makowsky BSP PharmD
  • Raegan Kijewski MD CCFP
  • Qudsiyyah Bhayat MBChC CCFP FCFP

1. Mitchell CM, Reed SD, Diem S, et al. JAMA Intern Med. 2018; 178(5):681-90.

2. Simon J, Nachtigall L, Gut R, et al. Obstet Gynecol. 2008; 112:1053-60.

3. Simunic V, Banovic I, Ciglar S, et al. Int J Gynaecol Obstet. 2003; 82(2):187-97.

4. Bachmann G, Lobo RA, Gut R, et al. Obstet Gynecol. 2008; 111:67-76.

5. Eriksen PS, Rasmussen H. Eur J Obstet Gynecol Reprod Biol. 1992; 44:137-44.

6. Cardozo LD, Wise BG, Benness CJ. J Obstet Gynecol. 2001; 21(4):383-5.

7. Simon J, Nachtigall L, Ulrich LG, et al. Obstet Gynecol. 2010; 116:876-83.

8. Ulrich LSG, Naessen T, Elia D, et al. Climacteric. 2010; 13:228-37.

9. Lethaby A, Ayeleke RO, Roberts H. Cochrane Database System Rev. 2016; 8:C001500.

10. Rahn DD, Carberry C, Sanses TV, et al. Obstet Gynecol. 2014; 124(6):1147-56.

11. Weber MA, Kleijn MH, Mangendam M, et al. PLoS ONE. 2015; 10(9):e0136265.

12. Grant MD, Marbella A, Wang AT, et al. AHRQ publication No. 15-EHC005-EF. Rockville, MA: Agency for Healthcare Research and Quality; March 2015. Available at: Accessed 13 May, 2019

13. Manonai J, Theppisai U, Suthutvoravut S, et al. J Obstet Gynaecol Res. 2001; 27(5):255-60.

Authors do not have any conflicts of interest to declare.

Les auteurs n’ont aucun conflit d’intérêts à déclarer.