Sexual Dysfunction, PhysiologicalPhase 2NCT06308614

Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women

A Phase 2 study testing Estetrol in people with Sexual Dysfunction, Physiological, run by Estetra at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 65 years, women only
Conditions the study is for: Sexual Dysfunction, Physiological
What is being tested?: Estetrol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 82 participants
Where: 24 sitesUnited States
Study dates: 29 Jan 2024to 21 Apr 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Main Inclusion Criteria:

Hysterectomized postmenopausal women, ≥40 up to ≤65 years, diagnosed with Female Sexual Arousal Disorder

Main Exclusion Criteria:

Not willing to stop any hormonal products during their participation in the study
History of unresolved sexual trauma or abuse that is contributing to any sexual dysfunction problem
Have experienced a recent major life stress or relationship discord that could interfere with sexual activity
Clinically significant abnormal gynecological findings
History of malignancy, with the exception of basal cell or squamous cell carcinoma of the skin
Systolic BP higher than 140 mmHg, diastolic BP higher than 90 mmHg
Is judged by the investigator to be unsuitable for any reason

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

Estetra Study Site
Albuquerque, New Mexico, 87102
Estetra Study Site
Atlanta, Georgia, 30328
Estetra Study Site
Chicago, Illinois, 60643
Estetra Study Site
Cleveland, Ohio, 44106
Estetra Study Site
Englewood, Ohio, 45322
Estetra Study Site
Houston, Texas, 77061
Estetra Study Site
Houston, Texas, 77074
Estetra Study Site
Jacksonville, Florida, 32256
Estetra Study Site
Las Vegas, Nevada, 89109
Estetra Study Site
Memphis, Tennessee, 38119
Estetra Study Site
Mesa, Arizona, 85209
Estetra Study Site
Miami, Florida, 33173
Estetra Study Site
New Port Richey, Florida, 34562
Estetra Study Site
Ocoee, Florida, 34761
Estetra Study Site
Omaha, Nebraska, 68114
Estetra Study Site
Orlando, Florida, 32801
Estetra Study Site
Phoenix, Arizona, 85032
Estetra Study Site
Pomona, California, 91767
Estetra Study Site
Salt Lake City, Utah, 84107
Estetra Study Site
San Diego, California, 92111
Estetra Study Site
Seattle, Washington, 98104
Estetra Study Site
Tucson, Arizona, 85715
Estetra Study Site
Virginia Beach, Virginia, 23456
Estetra Study Site
West Palm Beach, Florida, 33409

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Proof-of-Concept Study to Evaluate the Efficacy and Safety of Estetrol in Postmenopausal Subjects With Female Sexual Arousal Disorder

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.

Read the detailed description

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.

Conditions: Sexual Dysfunction, Physiological
Being tested: Estetrol, Placebo
Keywords: Female Sexual Arousal Disorder, FSAD
Medical subject headings: Sexual Dysfunction, Physiological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EstetrolDrug
Also called E4
Estetrol monohydrate 20 mg, equivalent to estetrol 18.9 mg
PlaceboOther
Matching Placebo to E4

Study groups in NCT06308614
Study group	Role	What they receive
Estetrol	Experimental	Estetrol monohydrate 20 mg, administered orally once daily for up to 12 weeks Receives: Drug: Estetrol
Placebo	Placebo comparator	Matching Placebo, administered orally once daily for up to 12 weeks Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: Baseline, Week 12.

Secondary outcomes (7)

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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, Week 12.
Change From Baseline to Week 12 in Sexual Function Assessed by PROMIS-SexFS
Refer to Description of Outcome Measure #3.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jan 202421 Apr 2025

First posted13 Mar 2024
Study start29 Jan 2024
Primary completion14 Mar 2025
Study completion21 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sexual Dysfunction, PhysiologicalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06308614
Sponsor's protocol ID: MIT-Do001-C206
Status last verified: Jun 2026
First submitted: 23 Jan 2024
Last updated: 6 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Proof-of-Concept Study to Evaluate the Efficacy and Safety of Estetrol in Postmenopausal Subjects With Female Sexual Arousal Disorder
ClinicalTrials.gov ID: NCT06308614
Acronym / sponsor ID: MIT-Do001-C206
Conditions: Sexual Dysfunction, Physiological
Keywords: Female Sexual Arousal Disorder, FSAD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: EstetraIndustry (pharma, biotech, devices)
Study start: 29 Jan 2024 (actual)
Primary completion: 14 Mar 2025 (actual)
Study completion: 21 Apr 2025 (actual)
First posted: 13 Mar 2024 (actual)
Results: Posted 6 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Estetrol	Experimental	Drug: EstetrolEstetrol monohydrate 20 mg, administered orally once daily for up to 12 weeks
Placebo	Placebo comparator	Other: PlaceboMatching Placebo, administered orally once daily for up to 12 weeks

Who may qualify

Ages: 40 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EstetrolAlso: E4Estetrol monohydrate 20 mg, equivalent to estetrol 18.9 mg	Drug	Estetrol
PlaceboMatching Placebo to E4	Other	Placebo

Primary outcome

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
Time frame: 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.
Change From Baseline to Week 12 in the Sexual Function Questionnaire 28 (SFQ-28) Arousal-Sensation Domain (Questions 6 to 9)
Time frame: 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).

7 secondary outcomes

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)
Time frame: Baseline, Week 12.
Change From Baseline to Week 12 in Sexual Function Assessed by FSDS-DAO -- Total Score
Time frame: 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)
Time frame: Baseline, Week 12.
Change From Baseline to Week 12 in Sexual Function Assessed by the Sexual Function Questionnaire 28 (SFQ-28) -- Total Score
Time frame: Baseline, Week 12.
Change From Baseline to Week 12 in Sexual Function Assessed by PROMIS-SexFS
Time frame: Baseline, Week 12.
Patient Global Impression of Change (PGIC) at Week 12
Time frame: Week 12.
Change From Baseline to Week 12 in Severity of Sexual Arousal Disorder as Assessed by Patient Global Impression of Severity (PGIS)
Time frame: Baseline, Week 12.

Results and safety

Results posted to the registry on 6 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Estetrol (E4)	41	37
Placebo	41	34

Primary outcome: 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

Time frame: Baseline, Week 12.. Least squares mean (95% Confidence Interval). Unit: score

Measure	Estetrol (E4) n = 37	Placebo n = 36
Value	-1.51 (-1.92 to -1.09)	-1.17 (-1.59 to -0.75)

Estetrol (E4) vs Placebo: Least square mean difference: -0.33 (95% CI -0.92 to 0.26), p = 0.2684, ANCOVA

Population analysed: 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.

Primary outcome: Change From Baseline to Week 12 in the Sexual Function Questionnaire 28 (SFQ-28) Arousal-Sensation Domain (Questions 6 to 9)

Time frame: Baseline, Week 12.. Least squares mean (95% Confidence Interval). Unit: scores on a scale

Measure	Estetrol (E4) n = 37	Placebo n = 36
Value	3.75 (2.34 to 5.17)	2.27 (0.88 to 3.66)

Estetrol (E4) vs Placebo: Least square mean difference: 1.49 (95% CI -0.50 to 3.47), p = 0.1393, ANCOVA

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Estetrol	0 of 41 (0%)	18 of 41 (43.9%)	0 of 41
Placebo	0 of 41 (0%)	10 of 41 (24.4%)	0 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Estetrol in people with Sexual Dysfunction, Physiological, run by Estetra at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline, Week 12.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06308614.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.