A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors

  • End date
    Sep 7, 2023
  • participants needed
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 7 June 2022
progesterone receptor
aromatase inhibitor


The purpose of this study is to determine if it is feasible for women to take both Flibanserin and tamoxifen for the duration of the study. 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 cancer.

Condition Breast Cancer, Hyposexual Desire Disorder
Treatment Flibanserin Pill
Clinical Study IdentifierNCT03707340
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on7 June 2022


Yes No Not Sure

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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