Efficacy of low-dose vaginal 17β-estradiol versus vaginal promestriene for vulvovaginal atrophy

Abstract

Objective

Vulvovaginal atrophy is frequent, can be bothersome and can impair quality of life in postmenopausal women. The main objective of this prospective, randomized study was to compare the acceptability of low-dose vaginal 17β-estradiol (estradiol) tablets and vaginal promestriene cream in postmenopausal women with moderate-to-severe symptomatic vulvovaginal atrophy.

Methods

Overall, 120 patients were randomized to receive estradiol or promestriene (n = 60 per group). Acceptability was assessed with a specific questionnaire. Symptom intensity, the Vaginal Health Index (VHI), vaginal pH and the Vaginal Maturation Index were also evaluated.

Results

Acceptability was higher for estradiol tablets. Compared to promestriene cream, hygiene and ease of use were greater after 4 weeks (p = 0.011 and p = 0.001, respectively) and after 12 weeks (p = 0.009 and p = 0.011, respectively). Reduction of symptom intensity was greater with estradiol. Both treatments improved the VHI and decreased vaginal pH. However, superficial cell percentages increased significantly (p < 0.001) with estradiol but not with promestriene (p = 0.241), with a statistically significant difference between means (p = 0.004).

Conclusion

Our results support the use of vaginal low-dose estradiol tablets as compared to vaginal promestriene cream for the management of moderate-to-severe symptomatic vulvovaginal atrophy in postmenopausal women.

ClinicalTrials.gov Identifier

NCT04232813

摘要

目的：外阴阴道萎缩很常见, 可能很麻烦, 并且会损害绝经后妇女的生活质量。这项前瞻性随机研究的主要目的是比较低剂量阴道 17β-雌二醇（雌二醇）片剂和阴道普罗雌烯乳膏在中度至重度症状性外阴阴道萎缩的绝经后妇女中的可接受性。

方法：总体而言, 120 名患者被随机分配接受雌二醇或普罗雌烯（每组 n = 60）。可接受性通过特定问卷进行评估。还评估了症状强度、阴道健康指数 (VHI)、阴道 pH 值和阴道成熟指数。

结果：雌二醇片剂的可接受性更高。与普罗雌烯乳膏相比, 4 周后（分别为 p = 0.011 和 p = 0.001）和 12 周后（分别为 p = 0.009 和 p = 0.011）, 卫生和易用性更高。雌二醇对症状强度的降低更大。两种治疗都改善了 VHI 并降低了阴道 pH 值。然而, 使用雌二醇（p<0.001）而不是普罗雌烯（p = 0.241）表层细胞百分比显着增加, 平均值之间存在统计学显着差异（p = 0.004）。

结论：与阴道普罗雌烯乳膏相比, 我们的结果支持使用阴道低剂量雌二醇片, 用于治疗绝经后妇女中重度症状性外阴阴道萎缩。

Keywords:

• Estradiol
• promestriene
• vaginal atrophy
• vaginal cream
• vaginal tablets

Potential conflict of interest

Novo Nordisk Health Care AG provided partial funding for the study but was not the sponsor.

Additional information

Funding

Medical writing support was provided by Content Ed Net (Madrid), with funding from Instituto Palacios, Madrid, Spain.