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This randomized, double-blind, placebo-controlled clinical trial investigated the effect of once daily oral administration of 20 mg estetrol monohydrate tablet for 12 weeks in postmenopausal women who experienced sexual arousal disorder. Specifically, the main aim was to evaluate whether estetrol (E4) is effective in the treatment of female sexual arousal disorder (FSAD) in women after their menopause.
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:
Secondary efficacy endpoints were the change from Baseline to Week 12:
The secondary efficacy endpoint Patient Global Impression of Change (PGIC) was assessed at Week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Estetrol | Experimental | Estetrol monohydrate 20 mg, administered orally once daily for up to 12 weeks |
|
| Placebo | Placebo Comparator | Matching Placebo, administered orally once daily for up to 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estetrol | Drug | Estetrol monohydrate 20 mg, equivalent to estetrol 18.9 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. |
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Main Inclusion Criteria:
• Hysterectomized postmenopausal women, ≥40 up to ≤65 years, diagnosed with Female Sexual Arousal Disorder
Main Exclusion Criteria:
Females, born as females
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Estetra Study Site | Mesa | Arizona | 85209 | United States | ||
| Estetra Study Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Estetrol (E4) | 20 mg estetrol monohydrate (E4) -- Active treatment |
| FG001 | Placebo | Matching Placebo to E4 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2023 | Mar 14, 2026 |
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| Placebo | Other | Matching Placebo to E4 |
|
| Baseline, Week 12. |
| Change From Baseline to Week 12 in Sexual Function Assessed by FSDS-DAO -- Total Score | 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) | 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 | 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 | Refer to Description of Outcome Measure #3. | Baseline, Week 12. |
| Patient Global Impression of Change (PGIC) at 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) | 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. |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Estetra Study Site | Tucson | Arizona | 85715 | United States |
| Estetra Study Site | Pomona | California | 91767 | United States |
| Estetra Study Site | San Diego | California | 92111 | United States |
| Estetra Study Site | Jacksonville | Florida | 32256 | United States |
| Estetra Study Site | Miami | Florida | 33173 | United States |
| Estetra Study Site | New Port Richey | Florida | 34562 | United States |
| Estetra Study Site | Ocoee | Florida | 34761 | United States |
| Estetra Study Site | Orlando | Florida | 32801 | United States |
| Estetra Study Site | West Palm Beach | Florida | 33409 | United States |
| Estetra Study Site | Atlanta | Georgia | 30328 | United States |
| Estetra Study Site | Chicago | Illinois | 60643 | United States |
| Estetra Study Site | Omaha | Nebraska | 68114 | United States |
| Estetra Study Site | Las Vegas | Nevada | 89109 | United States |
| Estetra Study Site | Albuquerque | New Mexico | 87102 | United States |
| Estetra Study Site | Cleveland | Ohio | 44106 | United States |
| Estetra Study Site | Englewood | Ohio | 45322 | United States |
| Estetra Study Site | Memphis | Tennessee | 38119 | United States |
| Estetra Study Site | Houston | Texas | 77061 | United States |
| Estetra Study Site | Houston | Texas | 77074 | United States |
| Estetra Study Site | Salt Lake City | Utah | 84107 | United States |
| Estetra Study Site | Virginia Beach | Virginia | 23456 | United States |
| Estetra Study Site | Seattle | Washington | 98104 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Demographic and Baseline Characteristics are presented for the Full Analysis Set (FAS).
The FAS is a subset of the Intent-to-Treat (ITT) analysis set and includes all randomized subjects with Baseline and Week 12 efficacy assessments FSDS-DAO Item 14 and SFQ-28 Arousal-Sensation Domain (Questions 6-9). In this analysis set, treatment was assigned based on the treatment to which subjects were randomized, regardless of which treatment they actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Estetrol | Estetrol monohydrate 20 mg (E4 20 mg), equivalent to estetrol 18.9 mg, administered orally once daily for up to 12 weeks. |
| BG001 | Placebo | Placebo, administered orally once daily for up to 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| FSDS-DAO, Item 14 | Refer to Description of Outcome Measure #1. | Mean | Standard Deviation | score |
| ||||||||||||||
| Sexual Function Questionnaire 28 (SFQ-28) Arousal-Sensation Domain (Questions 6 to 9) | 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). | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Arousal and Lubrication Assessed by PROMIS-SexFS Questionnaire | Refer to Description of Outcome Measure #3. PROMIS = Patient Reported Outcomes Measurement Information System; SexFS = Sexual Function and Satisfaction. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| FSDS-DAO -- Total Score | Refer to Description of Outcome Measure #4. | Mean | Standard Deviation | score |
| ||||||||||||||
| Percentage of Satisfying Sexual Events (SSE) | Refer to Description of Outcome Measure #5. Data captured in Arousal Electronic Diary. | Only participants with data available at baseline and week 12 are reported. | Mean | Standard Deviation | Percentage of SSE |
| |||||||||||||
| Sexual Function Questionnaire 28 (SFQ-28) -- Total Score | 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). | Only participants with data available at baseline and week 12 are reported. | Mean | Standard Deviation | scores on a scale |
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| PROMIS-SexFS: Interest in Sexual Activity | Refer to Description of Outcome Measure #3. | Mean | Standard Deviation | scores on a scale |
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| PROMIS-SexFS: Orgasm- pleasure | Refer to Description of Outcome Measure #3. | Mean | Standard Deviation | scores on a scale |
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| PROMIS-SexFS: Orgasm- ability | Refer to Description of Outcome Measure #3. | Mean | Standard Deviation | scores on a scale |
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| PROMIS-SexFS: Satisfaction with Sex Life | Refer to Description of Outcome Measure #3. | Mean | Standard Deviation | scores on a scale |
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| PROMIS-SexFS: Vaginal Discomfort for Sexual Activity | Refer to Description of Outcome Measure #3. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| PROMIS-SexFS: Vulvar Discomfort with Sexual Activity - labial | Refer to Description of Outcome Measure #3. | Mean | Standard Deviation | scores on a scale |
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| PROMIS-SexFS: Vulvar Discomfort with Sexual Activity - clitoral | Refer to Description of Outcome Measure #3. | Mean | Standard Deviation | scores on a scale |
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| PROMIS-SexFS: Oral Discomfort | Refer to Description of Outcome Measure #3. | Mean | Standard Deviation | scores on a scale |
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| PROMIS-SexFS: Oral Dryness | Refer to Description of Outcome Measure #3. | Mean | Standard Deviation | scores on a scale |
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| PROMIS-SexFS: Anal Discomfort | Refer to Description of Outcome Measure #3. | Mean | Standard Deviation | scores on a scale |
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| Patient Global Impression of Severity (PGIS) | Refer to Description of Outcome Measure #9. | Only participants with data available at baseline and week 12 are reported. | Mean | Standard Deviation | scores on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | The FAS is a subset of the Intent-to-Treat (ITT) analysis set and includes all randomized subjects with Baseline and Week 12 efficacy assessments FSDS-DAO Item 14 and SFQ-28 Arousal-Sensation Domain (Questions 6-9). In this analysis set, treatment was assigned based on the treatment to which subjects were randomized, regardless of which treatment they actually received. | Posted | Least Squares Mean | 95% Confidence Interval | score | Baseline, Week 12. |
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| Primary | Change From Baseline to Week 12 in the Sexual Function Questionnaire 28 (SFQ-28) Arousal-Sensation Domain (Questions 6 to 9) | 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). | The FAS is a subset of the Intent-to-Treat (ITT) analysis set and includes all randomized subjects with Baseline and Week 12 efficacy assessments FSDS-DAO Item 14 and SFQ-28 Arousal-Sensation Domain (Questions 6-9). In this analysis set, treatment was assigned based on the treatment to which subjects were randomized, regardless of which treatment they actually received. | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | Baseline, Week 12. |
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| Secondary | 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) | 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. | The FAS is a subset of the Intent-to-Treat (ITT) analysis set and includes all randomized subjects with Baseline and Week 12 efficacy assessments FSDS-DAO Item 14 and SFQ-28 Arousal-Sensation Domain (Questions 6-9). In this analysis set, treatment was assigned based on the treatment to which subjects were randomized, regardless of which treatment they actually received. | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | Baseline, Week 12. |
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| Secondary | Change From Baseline to Week 12 in Sexual Function Assessed by FSDS-DAO -- Total Score | 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. | The FAS is a subset of the Intent-to-Treat (ITT) analysis set and includes all randomized subjects with Baseline and Week 12 efficacy assessments FSDS-DAO Item 14 and SFQ-28 Arousal-Sensation Domain (Questions 6-9). In this analysis set, treatment was assigned based on the treatment to which subjects were randomized, regardless of which treatment they actually received. | Posted | Least Squares Mean | 95% Confidence Interval | score | Baseline, Week 12. |
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| Secondary | Change From Baseline to Week 12 in Sexual Function Assessed by Percentage of Satisfying Sexual Events (SSE) -- Captured in Arousal Electronic Diary (Ediary) | 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. | The FAS is a subset of the Intent-to-Treat (ITT) analysis set and includes all randomized subjects with Baseline and Week 12 efficacy assessments FSDS-DAO Item 14 and SFQ-28 Arousal-Sensation Domain (Questions 6-9). In this analysis set, treatment was assigned based on the treatment to which subjects were randomized, regardless of which treatment they actually received. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of SSE | Baseline, Week 12. |
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| Secondary | Change From Baseline to Week 12 in Sexual Function Assessed by the Sexual Function Questionnaire 28 (SFQ-28) -- Total Score | 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). | The FAS is a subset of the Intent-to-Treat (ITT) analysis set and includes all randomized subjects with Baseline and Week 12 efficacy assessments FSDS-DAO Item 14 and SFQ-28 Arousal-Sensation Domain (Questions 6-9). In this analysis set, treatment was assigned based on the treatment to which subjects were randomized, regardless of which treatment they actually received. | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | Baseline, Week 12. |
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| Secondary | Change From Baseline to Week 12 in Sexual Function Assessed by PROMIS-SexFS | Refer to Description of Outcome Measure #3. | The FAS is a subset of the Intent-to-Treat (ITT) analysis set and includes all randomized subjects with Baseline and Week 12 efficacy assessments FSDS-DAO Item 14 and SFQ-28 Arousal-Sensation Domain (Questions 6-9). In this analysis set, treatment was assigned based on the treatment to which subjects were randomized, regardless of which treatment they actually received. | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | Baseline, Week 12. |
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| Secondary | Patient Global Impression of Change (PGIC) at 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. | The FAS is a subset of the Intent-to-Treat (ITT) analysis set and includes all randomized subjects with Baseline and Week 12 efficacy assessments FSDS-DAO Item 14 and SFQ-28 Arousal-Sensation Domain (Questions 6-9). In this analysis set, treatment was assigned based on the treatment to which subjects were randomized, regardless of which treatment they actually received. One participant of the E4 group and one participant of the Placebo group did not answer the PGIC questionnaire. | Posted | Count of Participants | Participants | Week 12. |
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| Secondary | Change From Baseline to Week 12 in Severity of Sexual Arousal Disorder as Assessed by Patient Global Impression of Severity (PGIS) | 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. | The FAS is a subset of the Intent-to-Treat (ITT) analysis set and includes all randomized subjects with Baseline and Week 12 efficacy assessments FSDS-DAO Item 14 and SFQ-28 Arousal-Sensation Domain (Questions 6-9). In this analysis set, treatment was assigned based on the treatment to which subjects were randomized, regardless of which treatment they actually received. | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | Baseline, Week 12. |
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Adverse events (AEs) were reported from Day 1 (allocation to treatment) until subject's study participation ended (Week 16 or early withdrawal from the study).
Evaluation of AEs (as Treatment-Emergent Adverse Events) was performed using the Safety (SAF) set. This includes all randomized subjects who received at least one dose of Investigational Medicinal Product (IMP). All subjects of the SAF set were analyzed according to the treatment they actually received. The SAF set was used for all safety analyses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Estetrol | Estetrol monohydrate 20 mg (E4 20 mg), equivalent to estetrol 18.9 mg, administered orally once daily for up to 12 weeks. | 0 | 41 | 0 | 41 | 18 | 41 |
| EG001 | Placebo | Placebo, administered orally once daily for up to 12 weeks. | 0 | 41 | 0 | 41 | 10 | 41 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
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| Breast tenderness | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
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| Nipple pain | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
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| Vaginal discharge | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Emotional disorder | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Removal of internal fixation | Surgical and medical procedures | MedDRA (26.1) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Transparency | Estetra SRL | +32 043254451 | clinical.trials_ESTR@gedeonrichter.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 25, 2024 | Mar 14, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004953 | Estetrol |
| ID | Term |
|---|---|
| D004964 | Estriol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
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| OG001 | Placebo | Placebo, administered orally once daily for up to 12 weeks. |
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