Can a 'female Viagra' help breast cancer survivors regain desire?
NCT ID NCT03707340
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether flibanserin, a drug for low sexual desire, can be safely taken by breast cancer survivors who are on tamoxifen or similar hormone therapies. About 43 women with a history of breast cancer and no current disease will take flibanserin for 24 weeks. The main goal is to see how many women stop the drug due to side effects or other issues, and to check for any safety problems.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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43 people
The number who actually took part.
- Started
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Sep 2018
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Women age 21 and older * Able to swallow tablets * History of stage 0-III breast cancer that is estrogen and/or progesterone receptor positive * History of breast cancer with no current evidence of disease and have completed primary treatment with any combination of surgery, radiation and/or chemotherapy at least 3 months ago and is currently on Tamoxifen, an AI, or ovarian suppression. * Has been taking tamoxifen, an AI, ,or ovarian suppression for at least 3 months. * Has LFTS within 2 times the upper limit of normal proven by a Comprehensive Metabolic Panel (CMP) performed within 6 months of protocol enrollment and while the patient was on Tamoxifen, an AI, or ovarian suppression * Patients meet criteria for the diagnosis of HSDD as defined by the DSM-IV and ISSWSH Consensus paper. The criteria states that there must be a decrease in sexual desire and this must be a change for at least 3 months from what it was previously. Personal distress resulting from this change must occur. Initial screening will take place with The Decreased Sexual Desire Screener, a 5-question screening tool developed and validated to aid clinicians in making the diagnosis of HSDD. A "yes" response to the first 4 questions on the screener is consistent with HSDD. * Patients must agree to follow the guidelines for alcohol consumption during the 24 weeks of treatment on study * English speaking * Able to participate in the informed consent process Exclusion Criteria: * Active secondary cancer requiring cytotoxic chemotherapy * History or current diagnosis of metastatic breast cancer. * Unwillingness to follow alcohol guidelines while taking flibanserin * Hepatic dysfunction (more than 2 times the upper limit of normal for alt, ast, t.bili or alk phos) proven by Comprehensive Metabolic Panel (CMP) performed within 6 months of protocol enrollment and while the patient was on Tamoxifen or an AI * Patients on strong CYP3A4 inhibitors including ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan * Patients on moderate CYP3A4 inhibitors including Amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, grapefruit juice * Non-English speaking * Unable to participate in the informed consent process
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan - Kettering Cancer Center
New York, New York, 10021, United States
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Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Cancer Center @ Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
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Norwalk Hospital
Norwalk, Connecticut, 06850, United States
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