Estetrol per il trattamento del disturbo dell'eccitazione sessuale femminile nelle donne in postmenopausa
Uno studio Proof-of-Concept di Fase 2, randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza di Estetrol in soggetti in postmenopausa con disturbo dell'eccitazione sessuale femminile
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Arizona
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Mesa, Arizona, Stati Uniti, 85209
- Estetra Study Site
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Phoenix, Arizona, Stati Uniti, 85032
- Estetra Study Site
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Tucson, Arizona, Stati Uniti, 85715
- Estetra Study Site
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California
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Pomona, California, Stati Uniti, 91767
- Estetra Study Site
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San Diego, California, Stati Uniti, 92111
- Estetra Study Site
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Florida
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Jacksonville, Florida, Stati Uniti, 32256
- Estetra Study Site
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Miami, Florida, Stati Uniti, 33173
- Estetra Study Site
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New Port Richey, Florida, Stati Uniti, 34562
- Estetra Study Site
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Ocoee, Florida, Stati Uniti, 34761
- Estetra Study Site
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Orlando, Florida, Stati Uniti, 32801
- Estetra Study Site
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West Palm Beach, Florida, Stati Uniti, 33409
- Estetra Study Site
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Georgia
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Atlanta, Georgia, Stati Uniti, 30328
- Estetra Study Site
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Illinois
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Chicago, Illinois, Stati Uniti, 60643
- Estetra Study Site
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68114
- Estetra Study Site
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89109
- Estetra Study Site
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87102
- Estetra Study Site
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Ohio
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Cleveland, Ohio, Stati Uniti, 44106
- Estetra Study Site
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Englewood, Ohio, Stati Uniti, 45322
- Estetra Study Site
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Tennessee
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Memphis, Tennessee, Stati Uniti, 38119
- Estetra Study Site
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Texas
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Houston, Texas, Stati Uniti, 77061
- Estetra Study Site
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Houston, Texas, Stati Uniti, 77074
- Estetra Study Site
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Utah
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Salt Lake City, Utah, Stati Uniti, 84107
- Estetra Study Site
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Virginia
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Virginia Beach, Virginia, Stati Uniti, 23456
- Estetra Study Site
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Washington
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Seattle, Washington, Stati Uniti, 98104
- Estetra Study Site
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Principali criteri di inclusione:
- Donne in postmenopausa isterectomizzate, di età compresa tra ≥ 40 e ≤ 65 anni, con diagnosi di disturbo dell'eccitazione sessuale femminile
Principali criteri di esclusione:
- Non sono disposti a sospendere l'assunzione di alcun prodotto ormonale durante la partecipazione allo studio
- Storia di traumi sessuali o abusi sessuali irrisolti che contribuiscono a qualsiasi problema di disfunzione sessuale
- Hai sperimentato recentemente un grave stress nella vita o un disaccordo relazionale che potrebbe interferire con l'attività sessuale
- Reperti ginecologici anomali clinicamente significativi
- Storia di tumori maligni, ad eccezione del carcinoma basocellulare o squamoso della pelle
- Pressione sistolica superiore a 140 mmHg, pressione diastolica superiore a 90 mmHg
- Viene giudicato dall'investigatore non idoneo per qualsiasi motivo
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Estetrol
Estetrol monohydrate 20 mg, administered orally once daily for up to 12 weeks
|
Estetrol monohydrate 20 mg, equivalent to estetrol 18.9 mg
Altri nomi:
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Comparatore placebo: Placebo
Matching Placebo, administered orally once daily for up to 12 weeks
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Abbinamento Placebo a E4
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: 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.
|
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Change From Baseline to Week 12 in the Sexual Function Questionnaire 28 (SFQ-28) Arousal-Sensation Domain (Questions 6 to 9)
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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)
Lasso di tempo: 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.
|
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Change From Baseline to Week 12 in Sexual Function Assessed by FSDS-DAO -- Total Score
Lasso di tempo: 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.
|
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Change From Baseline to Week 12 in Sexual Function Assessed by Percentage of Satisfying Sexual Events (SSE) -- Captured in Arousal Electronic Diary (Ediary)
Lasso di tempo: 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
Lasso di tempo: 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.
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Change From Baseline to Week 12 in Sexual Function Assessed by PROMIS-SexFS
Lasso di tempo: Baseline, Week 12.
|
Refer to Description of Outcome Measure #3.
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Baseline, Week 12.
|
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Patient Global Impression of Change (PGIC) at Week 12
Lasso di tempo: 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)
Lasso di tempo: 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.
|
Altre misure di risultato
Misura del risultato |
Lasso di tempo |
|---|---|
|
Frequenza degli eventi avversi emergenti dal trattamento (TEAE) (compresi gli eventi avversi gravi emergenti dal trattamento [TESAE]).
Lasso di tempo: 12 settimane
|
12 settimane
|
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Pressione sanguigna (sistolica e diastolica) in ciascun punto temporale misurato.
Lasso di tempo: 12 settimane
|
12 settimane
|
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Frequenza respiratoria in ciascun punto temporale misurato.
Lasso di tempo: 12 settimane
|
12 settimane
|
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Frequenza cardiaca in ciascun punto temporale misurato.
Lasso di tempo: 12 settimane
|
12 settimane
|
Collaboratori e investigatori
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MIT-Do001-C206
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