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Purpose <p>Genitourinary Syndrome of Menopause (GSM) remains a significant unmet need for postmenopausal breast cancer survivors receiving aromatase inhibitor (AI) therapy.</p> Methods <p>In this randomized, controlled, open-label clinical trial, ER+ breast cancer survivors receiving adjuvant AI therapy with symptomatic GSM were randomized to receive 24 weeks of a non-hormonal vaginal moisturizer (Replens<sup>®</sup>) or vaginal estrogen therapy (either Vagifem<sup>®</sup> vaginal tablets or Estring<sup>®</sup> vaginal ring). The primary endpoint was change in vaginal dryness. Secondary endpoints included dyspareunia, sexual functioning, vaginal pH, and serum estradiol values.</p> Results <p>Twenty-three patients were enrolled (vaginal estrogen [VE], <i>n</i> = 11; non-hormonal [NH], <i>n</i> = 12). Vaginal dryness and dyspareunia scores improved significantly in the VE arm compared with the NH arm (<i>p</i> = 0.049, <i>p</i> = 0.048, respectively). Vaginal pH decreased significantly with vaginal estrogen compared to non-hormonal therapy (<i>p</i> = 0.0286). Other domains of sexual function (libido, ability to achieve orgasm, sexual satisfaction, and relationship with partner) were not significantly different between the 2 groups. Serum estradiol levels remained low through the first 12 weeks of therapy. Two participants demonstrated estradiol elevations above threshold at 24 weeks (21.8 pg/mL and 16 pg/mL); both reported non-adherence to AI therapy preceding measurement.</p> Conclusion <p>In this randomized study, vaginal estrogen provided greater improvement in vaginal dryness and dyspareunia than non-hormonal therapy in breast cancer survivors. These findings provide prospective evidence supporting symptomatic benefit with minimal systemic estrogen exposure in most patients, although larger studies with longer follow up are needed to define long-term safety and efficacy.</p>

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VEMORA: Vaginal Estrogen versus non-hormonal MOisturizer in women Receiving Aromatase inhibitors: a randomized, controlled trial

  • 期刊论文

  • 发表日期：

    2026年7月30日

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  • Polly Niravath,
  • Mothaffar Rimawi,
  • Kai Sun,
  • Hanh Mai,
  • Akshjot Puri,
  • Anuja Vyas,
  • Julie Nangia,
  • Alexys Brock,
  • Claudette Foreman,
  • Humaira Adnan,
  • Marianne Shafer,
  • Anushka Anand,
  • Abyssania Moges,
  • Ebtesam Al Najjar,
  • Sunil Mathur,
  • Danielle Antosh,
  • Rachel High,
  • Tarrik Zaid,
  • Jenny Chang,
  • Kent Osborne

摘要

Purpose

Genitourinary Syndrome of Menopause (GSM) remains a significant unmet need for postmenopausal breast cancer survivors receiving aromatase inhibitor (AI) therapy.

Methods

In this randomized, controlled, open-label clinical trial, ER+ breast cancer survivors receiving adjuvant AI therapy with symptomatic GSM were randomized to receive 24 weeks of a non-hormonal vaginal moisturizer (Replens®) or vaginal estrogen therapy (either Vagifem® vaginal tablets or Estring® vaginal ring). The primary endpoint was change in vaginal dryness. Secondary endpoints included dyspareunia, sexual functioning, vaginal pH, and serum estradiol values.

Results

Twenty-three patients were enrolled (vaginal estrogen [VE], n = 11; non-hormonal [NH], n = 12). Vaginal dryness and dyspareunia scores improved significantly in the VE arm compared with the NH arm (p = 0.049, p = 0.048, respectively). Vaginal pH decreased significantly with vaginal estrogen compared to non-hormonal therapy (p = 0.0286). Other domains of sexual function (libido, ability to achieve orgasm, sexual satisfaction, and relationship with partner) were not significantly different between the 2 groups. Serum estradiol levels remained low through the first 12 weeks of therapy. Two participants demonstrated estradiol elevations above threshold at 24 weeks (21.8 pg/mL and 16 pg/mL); both reported non-adherence to AI therapy preceding measurement.

Conclusion

In this randomized study, vaginal estrogen provided greater improvement in vaginal dryness and dyspareunia than non-hormonal therapy in breast cancer survivors. These findings provide prospective evidence supporting symptomatic benefit with minimal systemic estrogen exposure in most patients, although larger studies with longer follow up are needed to define long-term safety and efficacy.