Centro de Oncologia e Hematologia Einstein Dayan-Daycoval, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.
Hospital Israelita Albert Einstein, Goiânia, Brazil.
Breast Cancer Res. 2024 Sep 16;26(1):133. doi: 10.1186/s13058-024-01886-7.
Premenopausal, high-risk, hormone receptor-positive breast cancer patients are often treated with ovarian suppression in combination with aromatase inhibitors (AI). This combination has important adverse effects, particularly in sexual function, such as vaginal dryness and loss of libido. There is no effective therapy for reduced sexual function in this setting. Our study aimed to determine the efficacy and safety, particularly regarding sexual function, of a low-dose, topical testosterone gel administration.
This is a pilot, single-center study, designed to evaluate the efficacy of topical testosterone gel (3 mg/day) in improving sexual function in 29 premenopausal patients on ovarian suppression in combination with an AI. The primary safety endpoint was to assess serum estradiol elevation. The primary efficacy endpoint was sexual function improvement, assessed by the Female Sexual Function Index questionnaire.
We report the results on 29 patients. Twenty-two patients (75%) completed the 3-month treatment, and seven discontinued treatment before completion, mostly due to logistical difficulties related to the COVID-19 pandemic. All patients maintained the value of baseline mass spectrometry assay for estradiol of less than 2.7 pg/mL during the undertaken measurements. We observed a significant improvement in Female Sexual Function Index measures over the visits, with an increase from a mean of 11.7 at baseline to 19.1 in the third month (p < 0.001), with the greatest improvement observed between the second and third months.
Our findings suggest that topical testosterone seems to be safe and may be effective in improving sexual function in patients on ovarian suppression and AI.
The project was submitted and approved through the hospital's SGPP platform in 11/26/2019 (Project No. SGPP 393819) and CAAE (Research Ethics Committee) (CAAE No 25609719.5.0000.007).
绝经前、高危、激素受体阳性的乳腺癌患者常接受卵巢抑制联合芳香化酶抑制剂（AI）治疗。这种联合治疗有重要的不良反应，特别是在性功能方面，如阴道干燥和性欲减退。在这种情况下，对于降低的性功能还没有有效的治疗方法。我们的研究旨在确定低剂量局部睾酮凝胶给药的疗效和安全性，特别是在性功能方面。
这是一项单中心的试点研究，旨在评估局部睾酮凝胶（3mg/天）在 29 名接受卵巢抑制联合 AI 治疗的绝经前患者中改善性功能的效果。主要的安全性终点是评估血清雌二醇升高。主要的疗效终点是通过女性性功能指数问卷评估性功能的改善。
我们报告了 29 名患者的结果。22 名患者（75%）完成了 3 个月的治疗，7 名患者在完成前停止了治疗，主要是由于与 COVID-19 大流行相关的后勤困难。在所有接受的测量中，所有患者的雌二醇基线质谱检测值均保持在 2.7pg/ml 以下。我们观察到女性性功能指数测量值在随访中显著改善，从基线的 11.7 分增加到第三个月的 19.1 分（p<0.001），其中第二和第三个月之间的改善最大。
我们的发现表明，局部睾酮似乎是安全的，可能有效改善卵巢抑制和 AI 治疗患者的性功能。
该项目于 2019 年 11 月 26 日通过医院的 SGPP 平台提交并获得批准（项目编号 SGPP 393819）和 CAAE（研究伦理委员会）（CAAE 编号 25609719.5.0000.007）。
