Estetrol til behandling af kvindelig seksuel ophidselsesforstyrrelse hos postmenopausale kvinder
En fase 2, randomiseret, dobbeltblind, placebo-kontrolleret Proof-of-Concept-undersøgelse til evaluering af effektiviteten og sikkerheden af Estetrol hos postmenopausale forsøgspersoner med kvindelig seksuel ophidselsesforstyrrelse
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Arizona
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Mesa, Arizona, Forenede Stater, 85209
- Estetra Study Site
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Phoenix, Arizona, Forenede Stater, 85032
- Estetra Study Site
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Tucson, Arizona, Forenede Stater, 85715
- Estetra Study Site
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California
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Pomona, California, Forenede Stater, 91767
- Estetra Study Site
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San Diego, California, Forenede Stater, 92111
- Estetra Study Site
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Florida
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Jacksonville, Florida, Forenede Stater, 32256
- Estetra Study Site
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Miami, Florida, Forenede Stater, 33173
- Estetra Study Site
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New Port Richey, Florida, Forenede Stater, 34562
- Estetra Study Site
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Ocoee, Florida, Forenede Stater, 34761
- Estetra Study Site
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Orlando, Florida, Forenede Stater, 32801
- Estetra Study Site
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West Palm Beach, Florida, Forenede Stater, 33409
- Estetra Study Site
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Georgia
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Atlanta, Georgia, Forenede Stater, 30328
- Estetra Study Site
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Illinois
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Chicago, Illinois, Forenede Stater, 60643
- Estetra Study Site
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68114
- Estetra Study Site
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89109
- Estetra Study Site
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87102
- Estetra Study Site
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- Estetra Study Site
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Englewood, Ohio, Forenede Stater, 45322
- Estetra Study Site
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38119
- Estetra Study Site
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Texas
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Houston, Texas, Forenede Stater, 77061
- Estetra Study Site
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Houston, Texas, Forenede Stater, 77074
- Estetra Study Site
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Utah
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Salt Lake City, Utah, Forenede Stater, 84107
- Estetra Study Site
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Virginia
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Virginia Beach, Virginia, Forenede Stater, 23456
- Estetra Study Site
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Washington
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Seattle, Washington, Forenede Stater, 98104
- Estetra Study Site
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Hovedinkluderingskriterier:
- Hysterektomerede postmenopausale kvinder, ≥40 op til ≤65 år, diagnosticeret med kvindelig seksuel ophidselsesforstyrrelse
Vigtigste ekskluderingskriterier:
- Ikke villig til at stoppe nogen hormonelle produkter under deres deltagelse i undersøgelsen
- Historie om uløst seksuelt traume eller misbrug, der bidrager til ethvert seksuelt dysfunktionsproblem
- Har for nylig oplevet en større livsstress eller uoverensstemmelser i forholdet, der kunne forstyrre seksuel aktivitet
- Klinisk signifikante abnorme gynækologiske fund
- Anamnese med malignitet, med undtagelse af basalcelle- eller pladecellekarcinom i huden
- Systolisk BP højere end 140 mmHg, diastolisk BP højere end 90 mmHg
- Bedømmes af efterforskeren som uegnet af en eller anden grund
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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
Andre navne:
|
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Placebo komparator: Placebo
Matching Placebo, administered orally once daily for up to 12 weeks
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Matcher placebo til E4
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: 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)
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.
|
Baseline, Week 12.
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Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Hyppighed af behandlingsfremkomne bivirkninger (TEAE'er) (herunder behandlingsfremkomne alvorlige bivirkninger [TESAE'er]).
Tidsramme: 12 uger
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12 uger
|
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Blodtryk (systolisk og diastolisk) på hvert målt tidspunkt.
Tidsramme: 12 uger
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12 uger
|
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Respirationsfrekvens på hvert målt tidspunkt.
Tidsramme: 12 uger
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12 uger
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Puls på hvert målt tidspunkt.
Tidsramme: 12 uger
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12 uger
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MIT-Do001-C206
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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