What side effects are associated with this type of intervention?

Common treatments for sexual dysfunction, particularly those involving estrogen receptor modulation like estetrol, include selective estrogen receptor modulators (SERMs) such as tamoxifen and raloxifene. Known side effects of these treatments can include hot flashes, leg cramps, and an increased risk of thromboembolic events. Additionally, while these treatments can decrease glandular tissue in conditions like gynecomastia, they may not result in complete resolution and can cause rare adverse events such as epigastric distress.

What prior FDA approvals exist?

The FDA has approved several treatments for sexual dysfunction, particularly focusing on hormone-based therapies. Estrogen receptor modulators, like estetrol, are being studied for their potential benefits. Previously approved treatments include various forms of estrogen therapy, such as estradiol gels and sprays, which are used to manage symptoms related to menopause that can affect sexual function. These therapies aim to alleviate symptoms by modulating estrogen receptors, similar to the mechanism being investigated for estetrol in the treatment of female sexual arousal disorder.

What other types of research exist?

Promising novel alternatives to Estetrol for treating sexual dysfunction in 2024 include: 1) Testosterone therapy, which has been shown to improve sexual function in postmenopausal women. 2) Flibanserin, a non-hormonal treatment that targets neurotransmitters to enhance sexual desire. 3) Bremelanotide, a melanocortin receptor agonist that has been approved for hypoactive sexual desire disorder. 4) Investigational drugs like Vyleesi, which is designed to activate pathways in the brain involved in sexual response. These alternatives offer different mechanisms of action and may be suitable based on individual patient profiles.

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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

Summary

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.

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).

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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).

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EstetrolExperimental Treatment1 Intervention

20 mg estetrol monohydrate

Group II: PlaceboPlacebo Group1 Intervention

Matching Placebo

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for sexual dysfunction, particularly those involving estrogen receptor modulation like estetrol, work by targeting hormonal pathways to improve sexual function. Estetrol, a natural estrogen, binds to estrogen receptors, which can help alleviate symptoms of sexual arousal disorder by enhancing vaginal lubrication, increasing blood flow, and improving overall sexual response. Understanding these mechanisms is crucial for patients as it helps them comprehend how the treatment can address their specific symptoms, leading to better adherence and more informed discussions with their healthcare providers.

Gas what: NO is not the only answer to sexual function.

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Who is running the clinical trial?

EstetraLead Sponsor

15 Previous Clinical Trials

75,310 Total Patients Enrolled

~15 spots leftby Dec 2024

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