Goldstein Sue W, Goldstein Irwin, Kim Noel N
San Diego Sexual Medicine, San Diego, CA 92120, United States.
Sexual Medicine, Alvarado Hospital, San Diego, CA 92120, United States.
Sex Med. 2023 Jun 20;11(3):qfad028. doi: 10.1093/sexmed/qfad028. eCollection 2023 Jun.
Prasterone, an intravaginal dyspareunia treatment in menopausal women, improves vaginal health through intracellular conversion of dehydroepiandrosterone into androgens and estrogens. Phase 3 trials for prasterone showed significant improvement in vaginal tissue health and reduction of pain.
To assess vestibular changes with daily use of intravaginal prasterone in menopausal women with moderate to severe dyspareunia.
This open-label prospective pilot study was conducted over 20 weeks. It included 11 menopausal women (median age, 56 years) who were treated daily with intravaginal inserts of 6.5-mg prasterone and assessed monthly. During vulvoscopy, vestibular pain was assessed by cotton-tipped swab testing, and vestibular and vaginal health was independently assessed with the Visual Scale (VS). In addition, vulvoscopic photographs were obtained and assessed via the Vulvoscopic Genital Tissue Appearance (VGTA) scale to evaluate overall genital tissue health. Mean changes from baseline for genital tissue health and pain assessments were analyzed by repeated measures 1-way analysis of variance, followed by a Dunnett post hoc test. Sexual event diaries were completed and adverse events recorded.
Outcomes included indices of genital tissue health: pain assessment by cotton-tipped swab testing, VS of the vestibule and vagina, VGTA, and sexual event diary.
Aggregate scores from the cotton-tipped swab test progressively improved, reaching statistical significance at week 16, which was maintained through week 20 (-7.27, = .019). VS scores significantly improved from baseline by week 4 and were maintained through week 20 for the vestibule (-3.00, = .004) and vagina (-4.00, = .002). An overall 1607 vulvoscopic photographs were examined; all showed reduction in vestibular erythema and pallor at the end of the study. The mean change from baseline at week 20 for the VGTA score was -7.9 ( = .0016). Intercourse associated with pain was reduced from 81.3% of initiated events during the first month of the study to 8.3% during the last month. Sexual activities that were discontinued due to discomfort were reduced from 45.8% to 6.3%. No prasterone-related serious adverse events were reported.
Prasterone, a safe and effective intravaginal hormone treatment, significantly improves vestibular health parameters.
Strengths are the prospective study design and the use of multiple outcome measures to assess vestibular tissue health and pain associated with sexual activity. Limitations are the small study cohort and use of nonvalidated outcome measures.
Our findings suggest that intravaginal prasterone exerts biologic activity on the androgenic endodermal vestibule, as the medication passes from vagina to vestibule, resulting in amelioration of pain associated with sexual activity.
普拉睾酮是一种用于治疗绝经后女性阴道性交困难的药物，它通过将脱氢表雄酮在细胞内转化为雄激素和雌激素来改善阴道健康。普拉睾酮的3期试验表明，其能显著改善阴道组织健康并减轻疼痛。
评估中度至重度性交困难的绝经后女性每日使用阴道内普拉睾酮后的前庭变化。
这项开放标签的前瞻性试点研究持续了20周。研究纳入了11名绝经后女性（中位年龄56岁），她们每天使用含6.5毫克普拉睾酮的阴道栓剂，并每月进行评估。在阴道镜检查期间，通过棉拭子测试评估前庭疼痛，并使用视觉量表（VS）独立评估前庭和阴道健康。此外，获取阴道镜照片并通过阴道镜生殖器组织外观（VGTA）量表进行评估，以评估整体生殖器组织健康。通过重复测量单因素方差分析，然后进行Dunnett事后检验，分析生殖器组织健康和疼痛评估相对于基线的平均变化。完成性活动日记并记录不良事件。
结果包括生殖器组织健康指标：棉拭子测试的疼痛评估、前庭和阴道的VS、VGTA以及性活动日记。
棉拭子测试的总评分逐渐改善，在第16周达到统计学显著性，并持续到第20周（-7.27，P = 0.019）。到第4周时，VS评分相对于基线显著改善，并在前庭（-3.00，P = 0.004）和阴道（-4.00，P = 0.002）持续到第20周。共检查了1607张阴道镜照片；所有照片均显示在研究结束时前庭红斑和苍白减轻。第20周时，VGTA评分相对于基线的平均变化为-7.9（P = 0.0016）。与疼痛相关的性交从研究第一个月开始的性活动中的81.3%减少到最后一个月的8.3%。因不适而中断的性活动从45.8%减少到6.3%。未报告与普拉睾酮相关的严重不良事件。
普拉睾酮是一种安全有效的阴道内激素治疗药物，能显著改善前庭健康参数。
优点是前瞻性研究设计以及使用多种结果测量方法来评估前庭组织健康和与性活动相关的疼痛。局限性是研究队列较小且使用了未经验证的结果测量方法。
我们的研究结果表明，阴道内普拉睾酮在前庭雄激素性内胚层上发挥生物活性，因为药物从阴道传递到前庭，从而减轻了与性活动相关的疼痛。
