Flibanserin for Low Libido in Breast Cancer Survivors

Not currently recruiting at 9 trial locations

Overseen By Jeanne Carter, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Tamoxifen, AI, ovarian suppression

Must not be taking: Strong CYP3A4 inhibitors

Disqualifiers: Metastatic cancer, Hepatic dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether women can safely take both Flibanserin (a medication for low sexual desire) and tamoxifen to determine if Flibanserin alleviates low sexual desire. It targets women who have had breast cancer, completed their main treatment, and are currently on tamoxifen or similar medications. A suitable candidate for this trial is a woman who had breast cancer, shows no current signs of cancer, has been taking tamoxifen for at least three months, and experiences a noticeable drop in sexual desire causing distress. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must continue taking tamoxifen, an AI, or ovarian suppression. You cannot participate if you are on certain medications like strong or moderate CYP3A4 inhibitors.

Is there any evidence suggesting that Flibanserin is likely to be safe for women taking tamoxifen?

Research shows that flibanserin, a drug for low sexual desire, has some known side effects. It can cause fatigue, trouble sleeping, and dry mouth. It might also induce sleepiness or dizziness, so caution is advised when driving or engaging in activities requiring full attention.

Another study found that flibanserin was generally safe and well-tolerated by women with low sexual desire over a long period. This study, which lasted 52 weeks, reported improvements in sexual function for many participants.

While flibanserin is approved for treating low sexual desire, it caused breast tumors in mice at high doses. This finding comes from research on mice, not humans, but remains important to consider.

Overall, flibanserin has some side effects but is considered safe for many women. Prospective trial participants should consider these findings and discuss them with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for HSDD?

Flibanserin is unique because it addresses hyposexual desire disorder (HSDD) in breast cancer survivors, a condition that often lacks targeted treatments. Unlike other options that might focus on hormonal changes or psychological support, Flibanserin works by modulating neurotransmitters in the brain, specifically targeting serotonin, dopamine, and norepinephrine levels. Researchers are excited about Flibanserin because it offers a non-hormonal approach, making it potentially safer for breast cancer survivors who are on hormone therapies like Tamoxifen or aromatase inhibitors. This novel mechanism could provide a much-needed solution for improving sexual desire without interfering with cancer treatments.

What evidence suggests that Flibanserin might be an effective treatment for hyposexual desire disorder in women taking tamoxifen?

Research has shown that flibanserin, the treatment under study in this trial, can help treat low sexual desire in women. In one study, women taking flibanserin reported a noticeable increase in sexual desire compared to those taking a placebo, which contains no active medicine. Another study found that premenopausal women using flibanserin experienced a better overall sexual experience. Specifically, the SNOWDROP trial demonstrated that postmenopausal women had improved sexual desire and satisfaction with flibanserin compared to a placebo. Overall, these studies suggest that flibanserin may boost sexual desire in women with low sexual interest. ^{2 6 7 8 9}

Who Is on the Research Team?

Shari Goldfarb, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Able to swallow tablets

Women age 21 and older

History of stage 0-III breast cancer that is estrogen and/or progesterone receptor positive

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Flibanserin and Tamoxifen to evaluate feasibility and effects on hyposexual desire disorder

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Flibanserin

How Is the Trial Designed?

Group I: Breast Cancer Pts with hyposexual desire disorder/HSDD Experimental Treatment 1 Intervention

Flibanserin is already approved in United States for the following indications:

Approved in United States as Addyi for:

• Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8847820/

Clinically Meaningful Benefit in Women with Hypoactive ... In a separate randomized, placebo-controlled trial, flibanserin has also been shown to significantly improve sexual desire, increase the number of satisfying ...

2. journals.lww.com journals.lww.com/md-journal/fulltext/2024/06210/role_of_flibanserin_in_managing_hypoactive_sexual.51.aspx

Role of flibanserin in managing hypoactive sexual desire... Compared to placebo, a higher number of premenopausal women using flibanserin 100 mg achieved improvements in the Patient's Global Impression of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2667164622000264

Drug flibanserin–in hypoactive sexual desire disorder Flibanserin has been proven in clinical trials to cause significant improvements in several measures of sexual desire and function in both premenopausal and ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26927498/

Efficacy and Safety of Flibanserin for the Treatment ... Treatment with flibanserin, on average, resulted in one-half additional SSE per month while statistically and clinically significantly increasing the risk ...

5. uchealth.com uchealth.com/wp-content/uploads/2013/12/Menopause-Efficacy-and-Safety-of-Flibanserin-in-Postmenopausal-Women-w-.pdf

results of the SNOWDROP trial - UC Health Conclusions: In naturally postmenopausal women with HSDD, flibanserin, compared with placebo, has been associated with improvement in sexual desire, improvement ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6198608/

Flibanserin: A controversial drug for female hypoactive sexual ... Flibanserin may cause CNS depression with somnolence and sedation. Fatigue, insomnia, and dry mouth can also occur. Patients should not drive or engage in other ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03707340

NCT03707340 | A Study of Flibanserin in Breast Cancer ... This study is also trying to find out if Flibanserin improves or has any effect on hyposexual desire disorder/HSDD in women who are taking tamoxifen for breast ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2015/022526orig1s000sumredt.pdf

022526Orig1s000 - accessdata.fda.gov Breast Cancer: As discussed previously, flibanserin causes malignant mammary tumors in female mice at exposures 3 and 10 times those achieved ...

9. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.focus.20200039

Treatment of Hypoactive Sexual Desire Disorder Among ... A 52-week open-label extension study found that flibanserin was safe and well tolerated. Sexual function improved among participants who were ...