Estetrol for Sexual Dysfunction

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether estetrol, a hormone treatment, can improve sexual arousal in postmenopausal women. Participants will take either estetrol or a placebo (a lookalike pill with no active ingredient) for 12 weeks to determine if estetrol makes a difference. Women who have had a hysterectomy and experience sexual arousal issues after menopause might be suitable candidates for this trial. As a Phase 2 trial, this research aims to measure the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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.

Is there any evidence suggesting that estetrol is likely to be safe for humans?

Research shows that estetrol (E4) is generally safe for people. In past studies, some participants using estetrol experienced side effects such as mood changes, weight gain, and breast tenderness. However, these side effects were usually mild and similar to those seen with other estrogen treatments.

Researchers have also studied estetrol for conditions like breast cancer and issues with sexual desire, enhancing their understanding of its safety. Although estetrol is not yet approved for treating sexual arousal disorder, its use in other areas suggests it is likely safe.

Since this trial is in an early stage, researchers are closely monitoring estetrol's safety. Based on earlier research, it appears to be a promising and safe option for post-menopausal women with sexual arousal disorder. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for sexual dysfunction, which often include medications like sildenafil (Viagra) or tadalafil (Cialis) that primarily enhance blood flow, estetrol offers a different approach. Estetrol is a naturally occurring estrogen that might have unique benefits in improving sexual function by potentially balancing hormonal levels, rather than just addressing physical symptoms. Researchers are excited about estetrol because it could provide a more holistic solution by targeting the hormonal aspect of sexual dysfunction, which might lead to improved outcomes for some individuals.

What evidence suggests that estetrol might be an effective treatment for sexual arousal disorder?

Research suggests that estetrol (E4) might help with sexual problems in women after menopause. Estetrol, a natural form of estrogen, could improve sexual arousal by balancing hormones. Although limited data exists on estetrol's effects on sexual arousal, its hormone-balancing properties suggest potential benefits. Estetrol has been used in birth control and was well-tolerated, encouraging further study of its benefits. More research is needed to confirm its effectiveness for sexual issues, but early results appear promising. Participants in this trial will receive either estetrol or a placebo to evaluate its effectiveness for sexual dysfunction. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-2-sexual-dysfunction-physiological-2024-a187e

Estetrol for Sexual Dysfunction · Info for Participants ... efficacy for patients with Physiological Disorder and Sexual Dysfunction ... How does the drug Estetrol differ from other treatments for sexual dysfunction?

2. sciencedirect.com sciencedirect.com/science/article/pii/S001078242200395X

Tolerability and safety of the estetrol/drospirenone ... Data are for participants who received confirmed treatment with estetrol ... Types of progestogens in combined oral contraception: effectiveness and side-effects.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18464023/

Estetrol review: profile and potential clinical applications Additional areas worth exploring are the treatment of breast and prostate cancer, hypoactive sexual desire disorder ... Estetrol / adverse effects; Estetrol / ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/13625187.2022.2093850

A novel estetrol-containing combined oral contraceptive Effects of an oral contraceptive containing estetrol and drospirenone on ovarian function. Contraception. 2021;103(6):386–393. (Open in a new window)PubMed ...

5. cosrh.org cosrh.org/Common/Uploaded%20files/documents/drovelis-new-product-review-october-2022.pdf

FSRH CEU new product review: Drovelis® estetrol/ ... Effects of an oral contraceptive containing estetrol and drospirenone on ovarian function. Contraception. 2021 Jun;103(6):386-393. doi ...

6. contraceptionjournal.org contraceptionjournal.org/article/S0010-7824(22)00395-X/fulltext

Pooled analysis of two multicenter, open-label phase 3 trials ... dysfunction, mood changes, weight gain, breast tenderness, and ... Data are for participants who received confirmed treatment with estetrol ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/drospirenone-and-estetrol-oral-route/description/drg-20512946

Drospirenone and estetrol (oral route) - Side effects & dosage ... sexual contact. This medicine is ... estetrol combination have not been performed in the pediatric population. However, pediatric-specific problems ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1521693424001317

The clinical relevance of having more than one estrogen in ... Effects of an oral contraceptive containing estetrol and drospirenone on ovarian function. Contraception, 103 (6) (2021), pp. 386-393. View PDFView article ...