Estetrol for Sexual Dysfunction

Recruiting at 23 trial locations

Overseen By Clinical Study Leader

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Estetra

Must not be taking: Hormonal products

Disqualifiers: Sexual trauma, Major stress, Hypertension, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

82 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing estetrol, a hormone treatment, in postmenopausal women with sexual arousal disorder. The goal is to see if estetrol can help by balancing hormone levels. Participants will take estetrol for a few months and their progress will be monitored. Estetrol has been studied for its potential in hormone therapy, showing improvements in postmenopausal women.

Will I have to stop taking my current medications?

If you are taking any hormonal products, you will need to stop them to participate in this trial.

How does the drug Estetrol differ from other treatments for sexual dysfunction?

Estetrol is unique because it is a naturally occurring estrogen that may offer a novel approach to treating sexual dysfunction, particularly in women, where there are currently no approved pharmacotherapies for conditions like hypoactive sexual desire disorder. Unlike other treatments that focus on male erectile dysfunction or use hormone replacement therapy, Estetrol's potential lies in its distinct hormonal properties and its application in female sexual health. ^{1 2 3 4 5}

Eligibility Criteria

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).

Inclusion Criteria

I am a woman aged 40-65, had a hysterectomy, and diagnosed with Female Sexual Arousal Disorder.

Exclusion Criteria

Judged by the investigator to be unsuitable for any reason

I have notable abnormal findings in my gynecological exam.

I have unresolved issues from past sexual trauma affecting my sexual function.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive estetrol or placebo for 12 weeks and complete a daily diary

12 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Estetrol

Trial Overview 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.

Participant Groups

Group I: Estetrol Experimental Treatment 1 Intervention

20 mg estetrol monohydrate

Group II: Placebo Placebo Group 1 Intervention

Matching Placebo

Who Is Running the Clinical Trial?

Estetra

Lead Sponsor

Trials

17

Recruited

176,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Optimizing the therapeutic approach of transurethral alprostadil. [2019]

2. Spain pubmed.ncbi.nlm.nih.gov

Tadalafil, a further innovation in the treatment of sexual dysfunction. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacologic treatment strategies for sexual dysfunction in patients with epilepsy and depression. [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

[Erectile dysfunction]. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Intracavernous Alprostadil Alfadex--an effective and well tolerated treatment for erectile dysfunction. Results of a long-term European study. [2019]