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Hormone Therapy

Estetrol for Sexual Dysfunction

Phase 2
Recruiting
Research Sponsored by Estetra
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

"This trial is testing a medication called estetrol to see if it can help women after menopause who have a sexual arousal disorder. Participants will take either estetrol or a placebo pill for

Who is the study for?
This trial is for hysterectomized postmenopausal women aged 40 to 65 with Female Sexual Arousal Disorder. Candidates should not have significant abnormal gynecological findings, unresolved sexual trauma, recent major stress or relationship issues affecting sex life, high blood pressure, be unwilling to stop hormonal products during the study, or a history of cancer (except certain skin cancers).Check my eligibility
What is being tested?
The trial tests if estetrol monohydrate (20 mg), a hormone treatment, can improve sexual arousal in postmenopausal women compared to a placebo. Participants will take the medication or placebo for 12 weeks and record their experiences daily while attending seven clinic visits.See study design
What are the potential side effects?
While specific side effects are not listed here, hormone treatments like estetrol can potentially cause mood changes, weight gain, breast tenderness or enlargement, nausea and headaches. The exact side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline to Week 12 in feeling concerned by difficulties with sexual arousal, assessed by FSDS-DAO Item 14.
Change from Baseline to Week 12 in the Sexual Function Questionnaire 28 (SFQ-28) Arousal-Sensation Domain (Questions 6 to 9).
Secondary outcome measures
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).
Change from Baseline to Week 12 in severity of sexual arousal disorder as assessed by Patient Global Impression of Severity (PGIS).
Change from Baseline to Week 12 in sexual function assessed by FSDS-DAO - total score.
+4 more
Other outcome measures
Blood pressure (systolic and diastolic) at each measured time point.
Frequency of treatment emergent adverse events (TEAEs) (including treatment-emergent serious adverse events [TESAEs]).
Heart rate at each measured time point.
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EstetrolExperimental Treatment1 Intervention
20 mg estetrol monohydrate
Group II: PlaceboPlacebo Group1 Intervention
Matching Placebo

Find a Location

Who is running the clinical trial?

EstetraLead Sponsor
15 Previous Clinical Trials
75,310 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current total number of participants being recruited for this clinical study?

"Indeed, information accessible on clinicaltrials.gov confirms that recruitment is ongoing for this clinical trial. Initially listed on January 29th, 2024, with the most recent update dated March 12th, 2024, the trial aims to enroll a total of 76 participants across its network of 15 sites."

Answered by AI

Are multiple facilities conducting this clinical trial within the city?

"The medical investigation is currently ongoing at 15 diverse locations, including but not limited to San Diego, Tucson, and Jacksonville. Opting for the nearest clinical site would reduce the necessity for extensive travel upon enrollment."

Answered by AI

Are individuals still eligible to participate in this ongoing research?

"Yes, information on clinicaltrials.gov indicates that recruitment for this trial is ongoing. The trial was originally listed on January 29th, 2024 and last modified on March 12th, 2024. It aims to enroll a total of 76 individuals across 15 different sites."

Answered by AI

Has Estetrol received approval from the FDA for medical use?

"The safety evaluation by Power rates Estetrol at 2 out of 3, as this Phase 2 trial has data affirming its safety without evidence yet for efficacy."

Answered by AI

Is there an upper age limit for participants in this study?

"To be eligible for participation, individuals must fall within the age bracket of 40 to 65 years. It is noted that there is only one study available for those under 18 and nine studies catered towards participants over the age of 65."

Answered by AI

Who else is applying?

What site did they apply to?
Estetra Study Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women
2024. "Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06308614.
All > Anaheim > Paid Studies Pasadena
~51 spots leftby Dec 2024
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