閉経後の女性における女性の性的興奮障害の治療のためのエステトロール
女性性的興奮障害のある閉経後の被験者におけるエステトロールの有効性と安全性を評価するための第 2 相、無作為化、二重盲検、プラセボ対照の概念実証研究
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Arizona
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Mesa、Arizona、アメリカ、85209
- Estetra Study Site
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Phoenix、Arizona、アメリカ、85032
- Estetra Study Site
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Tucson、Arizona、アメリカ、85715
- Estetra Study Site
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California
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Pomona、California、アメリカ、91767
- Estetra Study Site
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San Diego、California、アメリカ、92111
- Estetra Study Site
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Florida
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Jacksonville、Florida、アメリカ、32256
- Estetra Study Site
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Miami、Florida、アメリカ、33173
- Estetra Study Site
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New Port Richey、Florida、アメリカ、34562
- Estetra Study Site
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Ocoee、Florida、アメリカ、34761
- Estetra Study Site
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Orlando、Florida、アメリカ、32801
- Estetra Study Site
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West Palm Beach、Florida、アメリカ、33409
- Estetra Study Site
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Georgia
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Atlanta、Georgia、アメリカ、30328
- Estetra Study Site
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Illinois
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Chicago、Illinois、アメリカ、60643
- Estetra Study Site
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Nebraska
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Omaha、Nebraska、アメリカ、68114
- Estetra Study Site
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Nevada
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Las Vegas、Nevada、アメリカ、89109
- Estetra Study Site
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New Mexico
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Albuquerque、New Mexico、アメリカ、87102
- Estetra Study Site
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Ohio
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Cleveland、Ohio、アメリカ、44106
- Estetra Study Site
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Englewood、Ohio、アメリカ、45322
- Estetra Study Site
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Tennessee
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Memphis、Tennessee、アメリカ、38119
- Estetra Study Site
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Texas
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Houston、Texas、アメリカ、77061
- Estetra Study Site
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Houston、Texas、アメリカ、77074
- Estetra Study Site
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Utah
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Salt Lake City、Utah、アメリカ、84107
- Estetra Study Site
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Virginia
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Virginia Beach、Virginia、アメリカ、23456
- Estetra Study Site
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Washington
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Seattle、Washington、アメリカ、98104
- Estetra Study Site
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
主な包含基準:
- 女性性的興奮障害と診断され、子宮摘出を受けた閉経後の女性（40歳以上65歳以下）
主な除外基準:
- 研究参加中にいかなるホルモン製剤も中止する意思がない
- 性機能障害の問題の一因となっている未解決の性的トラウマまたは性的虐待の病歴
- 最近、性行為に支障をきたす可能性のある大きな生活上のストレスや人間関係の不和を経験したことがある
- 臨床的に重大な異常な婦人科所見
- 皮膚の基底細胞癌または扁平上皮癌を除く悪性腫瘍の病歴
- 収縮期血圧が140 mmHg以上、拡張期血圧が90 mmHg以上
- 何らかの理由により調査官が不適当と判断した場合
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Estetrol
Estetrol monohydrate 20 mg, administered orally once daily for up to 12 weeks
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Estetrol monohydrate 20 mg, equivalent to estetrol 18.9 mg
他の名前：
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プラセボコンパレーター：Placebo
Matching Placebo, administered orally once daily for up to 12 weeks
|
プラセボを E4 に一致させる
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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)
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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)
時間枠：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
時間枠：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)
時間枠：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.
|
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Change From Baseline to Week 12 in Sexual Function Assessed by the Sexual Function Questionnaire 28 (SFQ-28) -- Total Score
時間枠：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
時間枠：Baseline, Week 12.
|
Refer to Description of Outcome Measure #3.
|
Baseline, Week 12.
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Patient Global Impression of Change (PGIC) at Week 12
時間枠：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.
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Change From Baseline to Week 12 in Severity of Sexual Arousal Disorder as Assessed by Patient Global Impression of Severity (PGIS)
時間枠：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.
|
その他の成果指標
結果測定 |
時間枠 |
|---|---|
|
治療緊急有害事象 (TEAE) (治療緊急重篤有害事象 [TESAE] を含む) の頻度。
時間枠：12週間
|
12週間
|
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各測定時点での血圧 (収縮期および拡張期)。
時間枠：12週間
|
12週間
|
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測定された各時点での呼吸数。
時間枠：12週間
|
12週間
|
|
測定された各時点の心拍数。
時間枠：12週間
|
12週間
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MIT-Do001-C206
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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