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Hormonal Therapies

Estrogen-based and androgen-based pharmacotherapy in reconstructive urology and urogynecology — genitourinary syndrome of menopause (GSM), perioperative hormonal priming, vesicovaginal-tissue optimization, and gender-affirming hormone therapy. The most consequential recent shifts: the November 2025 FDA boxed-warning removal for vaginal estrogen, the IMPROVE trial (Rahn 2023 JAMA) establishing preoperative vaginal estrogen as evidence-supported tissue priming, and the van Zijverden 2025 Dutch cohort + Skeith 2026 NEJM review reshaping the cardiovascular-risk conversation in gender-affirming hormone therapy.

For testosterone replacement in male hypogonadism see Sexual Medicine & Andrology. For GSM and Gender-Affirming Surgery clinical articles see the linked pages.

  • Vaginal & Topical EstrogenAUA/CUA/SUFU 2022 rUTI recommendation + 2020 NAMS Position Statement. Full formulation table with systemic-absorption gradient (Imvexxy 4 µg → Estring 7.5 µg/day → Vagifem → creams). Chen 2021 meta (RR 0.42 vaginal vs RR 1.11 oral); Tan-Kim 2023 Kaiser n = 5,638 51.9% reduction; Srinivasan 2022 JAMA Netw Open 26% → 80% Lactobacillus-dominant microbiome; Beste 2025 / McVicker 2024 JAMA Oncol breast-cancer-survivor safety; November 2025 FDA boxed-warning removal.
  • Vaginal DHEA (Prasterone)Intracrinology mechanism (Cellai 2021); Labrie 2018 pivotal; Labrie 2015 all-six-FSFI-domain signal (the defining differentiator from vaginal estrogen); Ke/Martel 2015–2016 LC-MS/MS showing serum E2 below postmenopausal; NCCTG 2018 AI-user systemic-E2-unchanged data; Mension 2022 VIBRA pilot in breast-cancer survivors on AIs; Archer 2017 indirect comparison vs CEE and estradiol.
  • OspemifeneSERM tissue-selectivity (vaginal agonist + bone agonist + breast antagonist). Take-with-food rule (2.3× Cmax); fluconazole 2.7× AUC collision; pivotal + Di Donato / Simon 2023 NMA; OAB / UUI as the strongest off-label signal (Schiavi 2017/2018 + Novara 2020 first-line-refractory + Russo 2023 urodynamic); Constantine 2015 endometrial safety; Nordstrom 2020 MarketScan VTE ~ 1/3 other SERMs; FDA-contraindicated-vs-EMA-approved breast-cancer divergence.
  • Preoperative Hormonal PrimingFramed around the IMPROVE trial (Rahn 2023 JAMA + Rahn 2024 AJOG 3-yr) as the evidence-turning-point; Rahn 2014 biopsy RCT (1.8× epithelium, 6× collagen); Vodegel 2022 meta; supported claims (tissue quality, postop complications, Cochrane RR 0.49 UTI, Zhou 2025 BMJ pessary-tolerance RCT) vs unsupported claims (prolapse recurrence, surgical success, sling mesh exposure); Cadish 2016 negative sling-mesh signal.
  • Gender-Affirming Hormone TherapyEndocrine Society 2017 + WPATH v8 / ACOG 2021 / AAFP 2023 framework. Feminizing table with 17β-estradiol preferred over ethinyl estradiol (20× VTE signal); spironolactone / cyproterone (not US) / GnRHa / finasteride antiandrogens; masculinizing testosterone regimens; van Zijverden 2025 Dutch cohort + Skeith 2026 NEJM CV-VTE review; Nos 2022 JAMA Netw Open puberty-suppression delaying-not-accelerating; De Roo 2025 fertility-preservation SR; perioperative 4–6 wk estrogen hold.