Clinical trial NCT06308614: Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Sexual Dysfunction, Physiological
Keywords: Female Sexual Arousal Disorder
FSAD
Lead sponsor: Estetra
Sponsor class: INDUSTRY
First posted: 2024-03-13
Enrollment: 82
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is investigating estetrol (E4) in women after menopause, suffering from sexual arousal disorder. The main question it aims to answer is: is 20 mg estetrol monohydrate effective in the treatment of sexual arousal disorder in women after their menopause. Participants will visit the clinic 7 times and complete a daily diary while receiving estetrol or placebo for 12 weeks. Placebo is a pill that looks the same as estetrol but has no active ingredient. Researchers will compare estetrol and placebo to see if estetrol has an effect on the sexual arousal of the participants.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline to Week 12 in feeling concerned by difficulties with sexual arousal, assessed by FSDS-DAO Item 14.
timeFrame: 12 weeks
measure: Change from Baseline to Week 12 in the Sexual Function Questionnaire 28 (SFQ-28) Arousal-Sensation Domain (Questions 6 to 9).
timeFrame: 12 weeks
Secondary outcomes:
measure: 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 (PROMISSexFS Questionnaire).
timeFrame: 12 weeks
measure: Change from Baseline to Week 12 in sexual function assessed by FSDS-DAO - total score.
timeFrame: 12 weeks
measure: Change from Baseline to Week 12 in sexual function assessed by Percentage of Satisfying Sexual Events (SSE) - captured in arousal electronic diary (ediary).
timeFrame: 12 weeks
measure: Change from Baseline to Week 12 in sexual function assessed by SFQ-28 - total score.
timeFrame: 12 weeks
measure: Change from Baseline to Week 12 in sexual function assessed by PROMIS-SexFS.
timeFrame: 12 weeks
measure: Patient Global Impression of Change (PGIC) at Week 12.
timeFrame: 12 weeks
measure: Change from Baseline to Week 12 in severity of sexual arousal disorder as assessed by Patient Global Impression of Severity (PGIS).
timeFrame: 12 weeks
Other outcomes:
measure: Frequency of treatment emergent adverse events (TEAEs) (including treatment-emergent serious adverse events [TESAEs]).
timeFrame: 12 weeks
measure: Blood pressure (systolic and diastolic) at each measured time point.
timeFrame: 12 weeks
measure: Respiratory rate at each measured time point.
timeFrame: 12 weeks
measure: Heart rate at each measured time point.
timeFrame: 12 weeks
Locations:
city: Mesa
country: United States
facility: Estetra Study Site
state: Arizona
city: Phoenix
country: United States
facility: Estetra Study Site
state: Arizona
city: Tucson
country: United States
facility: Estetra Study Site
state: Arizona
city: Pomona
country: United States
facility: Estetra Study Site
state: California
city: San Diego
country: United States
facility: Estetra Study Site
state: California
city: Jacksonville
country: United States
facility: Estetra Study Site
state: Florida
city: Miami
country: United States
facility: Estetra Study Site
state: Florida
city: New Port Richey
country: United States
facility: Estetra Study Site
state: Florida
city: Ocoee
country: United States
facility: Estetra Study Site
state: Florida
city: Orlando
country: United States
facility: Estetra Study Site
state: Florida
city: West Palm Beach
country: United States
facility: Estetra Study Site
state: Florida
city: Atlanta
country: United States
facility: Estetra Study Site
state: Georgia
city: Chicago
country: United States
facility: Estetra Study Site
state: Illinois
city: Omaha
country: United States
facility: Estetra Study Site
state: Nebraska
city: Las Vegas
country: United States
facility: Estetra Study Site
state: Nevada
city: Albuquerque
country: United States
facility: Estetra Study Site
state: New Mexico
city: Cleveland
country: United States
facility: Estetra Study Site
state: Ohio
city: Englewood
country: United States
facility: Estetra Study Site
state: Ohio
city: Memphis
country: United States
facility: Estetra Study Site
state: Tennessee
city: Houston
country: United States
facility: Estetra Study Site
state: Texas
city: Houston
country: United States
facility: Estetra Study Site
state: Texas
city: Salt Lake City
country: United States
facility: Estetra Study Site
state: Utah
city: Virginia Beach
country: United States
facility: Estetra Study Site
state: Virginia
city: Seattle
country: United States
facility: Estetra Study Site
state: Washington
Study officials:
References: