Estetrol para el tratamiento del trastorno de la excitación sexual femenina en mujeres posmenopáusicas
Un estudio de prueba de concepto de fase 2, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y seguridad del estetrol en sujetos posmenopáusicas con trastorno de la excitación sexual femenina
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Arizona
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Mesa, Arizona, Estados Unidos, 85209
- Estetra Study Site
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Phoenix, Arizona, Estados Unidos, 85032
- Estetra Study Site
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Tucson, Arizona, Estados Unidos, 85715
- Estetra Study Site
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California
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Pomona, California, Estados Unidos, 91767
- Estetra Study Site
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San Diego, California, Estados Unidos, 92111
- Estetra Study Site
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Florida
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Jacksonville, Florida, Estados Unidos, 32256
- Estetra Study Site
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Miami, Florida, Estados Unidos, 33173
- Estetra Study Site
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New Port Richey, Florida, Estados Unidos, 34562
- Estetra Study Site
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Ocoee, Florida, Estados Unidos, 34761
- Estetra Study Site
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Orlando, Florida, Estados Unidos, 32801
- Estetra Study Site
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West Palm Beach, Florida, Estados Unidos, 33409
- Estetra Study Site
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Georgia
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Atlanta, Georgia, Estados Unidos, 30328
- Estetra Study Site
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Illinois
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Chicago, Illinois, Estados Unidos, 60643
- Estetra Study Site
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68114
- Estetra Study Site
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89109
- Estetra Study Site
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87102
- Estetra Study Site
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- Estetra Study Site
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Englewood, Ohio, Estados Unidos, 45322
- Estetra Study Site
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38119
- Estetra Study Site
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Texas
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Houston, Texas, Estados Unidos, 77061
- Estetra Study Site
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Houston, Texas, Estados Unidos, 77074
- Estetra Study Site
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Utah
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Salt Lake City, Utah, Estados Unidos, 84107
- Estetra Study Site
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Virginia
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Virginia Beach, Virginia, Estados Unidos, 23456
- Estetra Study Site
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Washington
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Seattle, Washington, Estados Unidos, 98104
- Estetra Study Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Principales criterios de inclusión:
- Mujeres posmenopáusicas histerectomizadas, ≥40 hasta ≤65 años, diagnosticadas con Trastorno de la excitación sexual femenina
Principales criterios de exclusión:
- No estar dispuesto a suspender ningún producto hormonal durante su participación en el estudio.
- Historial de trauma o abuso sexual no resuelto que esté contribuyendo a cualquier problema de disfunción sexual.
- Ha experimentado recientemente un estrés importante en la vida o una discordia en la relación que podría interferir con la actividad sexual.
- Hallazgos ginecológicos anormales clínicamente significativos.
- Historia de malignidad, con excepción de carcinoma de células basales o de células escamosas de la piel.
- PA sistólica superior a 140 mmHg, PA diastólica superior a 90 mmHg
- El investigador lo considera inadecuado por cualquier motivo.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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
Otros nombres:
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Comparador de placebos: Placebo
Matching Placebo, administered orally once daily for up to 12 weeks
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Emparejar placebo con E4
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
Periodo de tiempo: Baseline, Week 12.
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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)
Periodo de tiempo: Baseline, Week 12.
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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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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)
Periodo de tiempo: Baseline, Week 12.
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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
Periodo de tiempo: Baseline, Week 12.
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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)
Periodo de tiempo: Baseline, Week 12.
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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
Periodo de tiempo: 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
Periodo de tiempo: Baseline, Week 12.
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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
Periodo de tiempo: Week 12.
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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)
Periodo de tiempo: Baseline, Week 12.
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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.
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Baseline, Week 12.
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Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
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Frecuencia de eventos adversos emergentes del tratamiento (ATEA) (incluidos eventos adversos graves emergentes del tratamiento [TESAE]).
Periodo de tiempo: 12 semanas
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12 semanas
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Presión arterial (sistólica y diastólica) en cada momento medido.
Periodo de tiempo: 12 semanas
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12 semanas
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Frecuencia respiratoria en cada momento medido.
Periodo de tiempo: 12 semanas
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12 semanas
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Frecuencia cardíaca en cada momento medido.
Periodo de tiempo: 12 semanas
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12 semanas
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Disfunción Sexual Fisiológica
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Compuestos policíclicos
- Esteroides
- Compuestos de anillo fusionado
- Estreness
- Estranos
- Congéneres de estradiol
- Hormonas esteroides gonadal
- Hormonas gonadales
- Estriol
- Estetrol
Otros números de identificación del estudio
- MIT-Do001-C206
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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