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雌四醇治疗绝经后女性性唤起障碍

2026年6月9日 更新者：Estetra

一项随机、双盲、安慰剂对照的第二阶段概念验证研究，旨在评估雌四醇对患有女性性唤起障碍的绝经后受试者的疗效和安全性

该临床试验的目的是调查绝经后患有性唤起障碍的女性中的雌四醇 (E4)。 它旨在回答的主要问题是：20毫克一水合雌四醇对于治疗绝经后女性的性唤起障碍是否有效。 参与者将前往诊所 7 次并完成每日日记，同时接受雌四醇或安慰剂治疗 12 周。 安慰剂是一种看起来与雌四醇相同但不含活性成分的药丸。 研究人员将比较雌四醇和安慰剂，看看雌四醇是否对参与者的性唤起有影响。

研究概览

地位

完全的

条件

干预/治疗

详细说明

Female Sexual Arousal Disorder (FSAD), a subtype of female sexual dysfunction, is an inability to attain or to maintain an adequate lubrication-swelling response of sexual excitement. FSAD may manifest as a decrease in vaginal lubrication and a decrease in genital sensation related to blood flow and can cause marked distress and/or interpersonal difficulty (Diagnostic and Statistical Manual (DSM) of Mental Disorders, 4th edition [DSMIV]). Estrogen has a role in maintaining genital tissue structural integrity and pelvic nerve-stimulated genital blood flow.

This study was conducted with estetrol (E4), assessing the efficacy and safety of estetrol monohydrate 20 mg (E4 20 mg), equivalent to estetrol 18.9 mg, for the treatment of FSAD associated with menopause in hysterectomized postmenopausal women.

The design of this Phase 2, Proof of Concept (POC) study was: randomized, double-blind, placebo-controlled, two-arm parallel group. Eligible subjects were randomized in a 1:1 ratio and received either an oral tablet of E4 20 mg or placebo, once daily for 12 weeks. Placebo tablet looked identical to E4 but had no active ingredient. During the study, participants visited the clinic 7 times and completed a daily e-diary. The results were evaluated regarding the effect of E4 and placebo on the sexual arousal of the participants, using several validated questionnaires.

The primary efficacy endpoints were the change from Baseline to Week 12:

  • in feeling concerned by difficulties with sexual arousal, assessed by Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) Item 14;
  • in the Sexual Function Questionnaire (SFQ-28) Arousal-Sensation Domain (Questions 6 to 9).

Secondary efficacy endpoints were the change from Baseline to Week 12:

  • in arousal and lubrication assessed by Patient-Reported Outcomes Measurement Information System-Sexual Function and Satisfaction (PROMIS-SexFS) Questionnaire;
  • in sexual function assessed by FSDS-DAO - total score and by percentage of Satisfying Sexual Event (SSE) captured in e-diary;
  • in sexual function assessed by SFQ-28 - total score;
  • in sexual function assessed by PROMIS-SexFS;
  • in severity of sexual arousal disorder as assessed by Patient Global Impression of Severity (PGIS).

The secondary efficacy endpoint Patient Global Impression of Change (PGIC) was assessed at Week 12.

研究类型

介入性

注册 (实际的)

82

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Arizona
      • Mesa、Arizona、美国、85209
        • Estetra Study Site
      • Phoenix、Arizona、美国、85032
        • Estetra Study Site
      • Tucson、Arizona、美国、85715
        • Estetra Study Site
    • California
      • Pomona、California、美国、91767
        • Estetra Study Site
      • San Diego、California、美国、92111
        • Estetra Study Site
    • Florida
      • Jacksonville、Florida、美国、32256
        • Estetra Study Site
      • Miami、Florida、美国、33173
        • Estetra Study Site
      • New Port Richey、Florida、美国、34562
        • Estetra Study Site
      • Ocoee、Florida、美国、34761
        • Estetra Study Site
      • Orlando、Florida、美国、32801
        • Estetra Study Site
      • West Palm Beach、Florida、美国、33409
        • Estetra Study Site
    • Georgia
      • Atlanta、Georgia、美国、30328
        • Estetra Study Site
    • Illinois
      • Chicago、Illinois、美国、60643
        • Estetra Study Site
    • Nebraska
      • Omaha、Nebraska、美国、68114
        • Estetra Study Site
    • Nevada
      • Las Vegas、Nevada、美国、89109
        • Estetra Study Site
    • New Mexico
      • Albuquerque、New Mexico、美国、87102
        • Estetra Study Site
    • Ohio
      • Cleveland、Ohio、美国、44106
        • Estetra Study Site
      • Englewood、Ohio、美国、45322
        • Estetra Study Site
    • Tennessee
      • Memphis、Tennessee、美国、38119
        • Estetra Study Site
    • Texas
      • Houston、Texas、美国、77061
        • Estetra Study Site
      • Houston、Texas、美国、77074
        • Estetra Study Site
    • Utah
      • Salt Lake City、Utah、美国、84107
        • Estetra Study Site
    • Virginia
      • Virginia Beach、Virginia、美国、23456
        • Estetra Study Site
    • Washington
      • Seattle、Washington、美国、98104
        • Estetra Study Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

主要纳入标准：

- 子宫切除的绝经后女性，年龄≥40岁至≤65岁，诊断患有女性性唤起障碍

主要排除标准：

  • 在参与研究期间不愿意停止任何激素产品
  • 未解决的性创伤或虐待史导致任何性功能障碍问题
  • 最近经历过可能干扰性活动的重大生活压力或关系不和谐
  • 有临床意义的妇科异常发现
  • 有恶性肿瘤病史，皮肤基底细胞癌或鳞状细胞癌除外
  • 收缩压高于140毫米汞柱，舒张压高于90毫米汞柱
  • 被研究者判定因任何原因不适合

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Estetrol
Estetrol monohydrate 20 mg, administered orally once daily for up to 12 weeks
药品：Estetrol
Estetrol monohydrate 20 mg, equivalent to estetrol 18.9 mg
其他名称：
  • E4
安慰剂比较：Placebo
Matching Placebo, administered orally once daily for up to 12 weeks
其他：安慰剂
将安慰剂与 E4 相匹配

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change From Baseline to Week 12 in Feeling Concerned by Difficulties With Sexual Arousal, Assessed by Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO), Item 14
大体时间：Baseline, Week 12.

The Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) is a validated 15-item self-assessment where each item is scored from 0 (never) to 4 (always). Higher scores on this scale, which has a total range of 0-60, indicate greater distress.

Item 14 assesses how often the subject has felt concerned by difficulties with sexual arousal during the past 30 days.
Baseline, Week 12.
Change From Baseline to Week 12 in the Sexual Function Questionnaire 28 (SFQ-28) Arousal-Sensation Domain (Questions 6 to 9)
大体时间：Baseline, Week 12.

The 28-item Sexual Function Questionnaire (SFQ-28) is a validated self-assessment tool to assess female sexual function. It has 8 domains, including domains for desire, arousal (sensation/lubrication/cognitive), orgasm, pain, enjoyment, and partner relationship. Questions are scored on a Likert scale (e.g., 0 to 5 or 1 to 5), where lower scores indicate higher levels of dysfunction.

Questions 6, 7, 8, and 9 deal with the domain "Arousal-sensation". Score range for this domain is: 4-20 (=sum of Questions 6-9).

Total score range is: 24-141 (=sum of all Questions 1-28).
Baseline, Week 12.

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline to Week 12 in Arousal and Lubrication Assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction (SexFS) Measures (PROMIS-SexFS Questionnaire)
大体时间：Baseline, Week 12.

The PROMIS-SexFS is an instrument to measure self-reported sexual function and satisfaction. In total, 24 questions (out of 26) are rated on a 5-point scale each, so that for each question, the score range may be 1-5 or 0-5 (0=not applicable). Questions (Q) can be grouped by domains; their scores are summed to calculate the domain score. There are 11 domains in total.

A higher score indicates a better outcome in the following domains: arousal and lubrication (3Q; 3-15), interest in sexual activity (2Q, score range: 2-10), orgasm-pleasure (2Q; 0-10), orgasm-ability (1Q; 0-5), and satisfaction with sex life (4Q; 3-20).

A higher score indicates a worse outcome in the following domains: vaginal discomfort (2Q; 2-10), vulvar discomfort (2Q; 2-10), vulvar dysfunction (2Q; 2-10), oral discomfort (2Q; 2-10), oral dryness (2Q; 2-10), anal discomfort (2Q; 2-10).

The 2 remaining questions of the questionnaire are for screening purposes.
Baseline, Week 12.
Change From Baseline to Week 12 in Sexual Function Assessed by FSDS-DAO -- Total Score
大体时间：Baseline, Week 12.
The Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) is a validated 15-item self-assessment where each item is scored from 0 (never) to 4 (always). Higher scores on this scale, which has a total range of 0-60, indicate greater distress.
Baseline, Week 12.
Change From Baseline to Week 12 in Sexual Function Assessed by Percentage of Satisfying Sexual Events (SSE) -- Captured in Arousal Electronic Diary (Ediary)
大体时间：Baseline, Week 12.

A higher number of Satisfying Sexual Events (SSE) indicates an improvement in sexual function.

The arousal electronic diary contains a questionnaire to be completed by the subject within 24 hours of a sexual event.
Baseline, Week 12.
Change From Baseline to Week 12 in Sexual Function Assessed by the Sexual Function Questionnaire 28 (SFQ-28) -- Total Score
大体时间：Baseline, Week 12.

The 28-item Sexual Function Questionnaire (SFQ-28) is a validated self-assessment tool to assess female sexual function. It has 8 domains, including domains for desire, arousal (sensation/lubrication/cognitive), orgasm, pain, enjoyment, and partner relationship. Questions are scored on a Likert scale (e.g., 0 to 5 or 1 to 5), where lower scores indicate higher levels of dysfunction.

Questions 6, 7, 8, and 9 deal with the domain "Arousal-sensation". Score range for this domain is: 4-20 (=sum of Questions 6-9).

Total score range is: 24-141 (=sum of all Questions 1-28).
Baseline, Week 12.
Change From Baseline to Week 12 in Sexual Function Assessed by PROMIS-SexFS
大体时间：Baseline, Week 12.
Refer to Description of Outcome Measure #3.
Baseline, Week 12.
Patient Global Impression of Change (PGIC) at Week 12
大体时间：Week 12.

Patient Global Impression of Change (PGIC) was used to measure changes in sexual arousal disorder. At Week 12, each enrolled subject was asked to rate their change in sexual arousal on 7-point Likert scale.

The results are presented as the number of participants. The grading of responses were from 'No Change' to 'A Great Deal Better', as shown in the results table below.
Week 12.
Change From Baseline to Week 12 in Severity of Sexual Arousal Disorder as Assessed by Patient Global Impression of Severity (PGIS)
大体时间：Baseline, Week 12.
Patient Global Impression of Severity (PGIS) was used to evaluate the severity of sexual arousal disorder at a given time. The subject is asked to rate the severity of their sexual arousal dysfunction on 7-point Likert scale (1=not present, 2=very mild, 3=mild, 4=moderate, 5=moderately severe, 6=severe, and 7=extremely severe). A lower score indicates an improvement.
Baseline, Week 12.

其他结果措施

结果测量
大体时间
治疗中出现的不良事件 (TEAE)（包括治疗中出现的严重不良事件 [TESAE]）的频率。
大体时间：12周
12周
每个测量时间点的血压（收缩压和舒张压）。
大体时间：12周
12周
每个测量时间点的呼吸频率。
大体时间：12周
12周
每个测量时间点的心率。
大体时间：12周
12周

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Estetra

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年1月29日

初级完成 (实际的)

2025年3月14日

研究完成 (实际的)

2025年4月21日

研究注册日期

首次提交

2024年1月23日

首先提交符合 QC 标准的

2024年3月12日

首次发布 (实际的)

2024年3月13日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年6月9日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MIT-Do001-C206

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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