Local ultra-low-dose estriol gel treatment of vulvo-vaginal atrophy: efficacy and safety of long-term treatment

Abstract

Vulvo-vaginal atrophy (VVA) is a chronic condition affecting many postmenopausal women. Local estrogen treatment is recommended. Evaluating efficacy and safety of long-term VVA treatment with ultra-low-dose estriol gel, 120 postmenopausal VVA women were enrolled in a prospective study. They received the first cycle of 1 g/day vaginal gel containing 50 µg estriol for 3 weeks and then twice a week for 12 weeks. Moderate or severe VVA women received a second treatment cycle reaching treatment of 30 weeks. Vaginal pH measurement, subjective symptoms, and objective signs assessment of VVA, endometrial thickness and adverse events (AE) were recorded. Of the 99 women, completing the first phase, 43% experienced a complete VVA symptom relief, and 65% presented a milder VVA degree. After 30 weeks, VVA signs significantly improved (p<.01) compared with baseline and first phase results; total objective symptom evaluation including Schiller’s test, flattening of folds and vaginal pH significantly improved (p<.01). At study endpoint, none of the patients had severe VVA, 93% had a positive response, 75% had a complete symptom, and sign resolution. No treatment-related endometrial AE were observed. Postmenopausal VVA long term-treatment with ultra-low-dose estriol vaginal gel is safe and effective.

摘要

外阴-阴道萎缩(VVA)是一种影响许多绝经后妇女的慢性疾病。局部雌激素治疗是推荐疗法。为评估超低剂量雌三醇凝胶用于VVA长期治疗的有效性和安全性, 纳入120名绝经后VVA患者加入前瞻性研究。第一周期应用含雌三醇50 mg的阴道凝胶1g每天一次, 共3周, 然后改为一周两次, 共12周。中度或重度VVA妇女进行第二周期治疗, 治疗时长共30周。记录阴道pH值、VVA的主观症状和客观体征、子宫内膜厚度和不良事件(AE)。在完成第一阶段治疗的99名妇女中, 43%的VVA症状完全缓解, 65%的表现为轻度VVA症状。30周后, 与基线水平和第一阶段的结果相比, VVA体征明显改善(p<0.01)。包括席勒试验、皱褶扁平化和阴道pH值在内的总体客观症状明显改善(p<0.01)。在研究终点, 没有一名患者有严重的VVA, 93%的患者有阳性反应, 75%的患者症状和体征完全消失。未观察到与治疗相关的子宫内膜AE。超低剂量雌三醇阴道凝胶长期治疗绝经后VVA是安全且有效的。

The Chinese abstracts are translated by Prof. Dr. Xiangyan Ruan and her team: Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China.

Keywords:

• Vaginal atrophy
• menopause
• estriol
• quality of life
• vaginal dryness

Disclosure statement

The authors declare no potential conflicts of interest.