Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

Aromatase Inhibitors

Eligible participants will begin treatment with flibanserin 100 mg orally daily at bedtime for 24-36 weeks and followed for a total of 52 weeks.

Flibanserin Pill

Shari Goldfarb, MD

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.

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

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

To evaluate the feasibility defined as the treatment discontinuation rate of flibanserin for 24 weeks due to toxicity, withdrawal of consent or other events related to tolerability.

The AE reporting period begins on the first day of study drug administration and continues until 4 weeks after the patient has taken the last dose of study drug. AE's will be evaluated using CTCAE v 4.

Memorial Sloan Kettering Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Prostatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Androgens

Hormones

Hormone Antagonists

Flibanserin at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).

Placebo at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).

Flibanserin 100mg tablets taken by mouth daily at bedtime

Flibanserin 100 MG

Visually identical placebo tablets taken by mouth daily at bedine

Placebo

Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.

Androgen deprivation therapy

Andrew McDonald, MD

This is a double-blinded, placebo-controlled randomized phase II clinical trial investigating whether flibanserin promotes sexual interest in men with prostate cancer who are receiving androgen suppression.

More than 40,000 men with prostate cancer in the United States will begin androgen deprivation therapy (ADT) each year. ADT is an important part of treatment, because it improves survival for men with metastatic or high-risk localized disease, and reduces rates of biochemical progression for men with intermediate-risk localized disease who receive radiation. The most common ADT agents modulate gonadotropin-releasing hormone to suppress the downstream testosterone production, resulting in testosterone levels similar to those observed following surgical castration (\<20 ng/dL). Since male sexual interest is highly correlated with serum testosterone levels, loss of sexual interest is nearly universal among men who receive ADT.Sexual dysfunction is the most common complaint among men with prostate cancer and contributes to lower overall quality of life (QoL) experienced by men receiving ADT. Furthermore, the loss of sexual interest experienced during ADT is highly distressing for men with prostate cancer and their partners, which contributes additional psychological morbidity in these patients.

Flibanserin is approved for treatment of female hypoactive sexual desire disorder, and the safety profile of 100mg daily flibanserin is well described in premenopausal women.The safety profile of flibanserin in healthy men has been assessed in multiple phase I clinical trials, but has not been evaluated among men receiving ADT for prostate cancer.

This is a phase II randomized, double-blinded, placebo-controlled clinical trial designed to provide an initial estimate of the efficacy of flibanserin to promote sexual interest in men with prostate cancer receiving androgen suppression therapy and to confirm the safety profile. This study will take place at a single academic comprehensive cancer center.

Following confirmation of eligibility, participants who are enrolled in this study are randomized to receive daily flibanserin 100mg or placebo for a 12-week period.

Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer

RAD 2003/XUAB2104: Randomized Phase II Trial of Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer

The number of patients in each arm reporting attempting sexual intercourse at least 3 times in the prior month (0-2 attempts vs. 3+ attempts) will be compared using the two-group chi-square test, or Fisher's exact test if the assumptions for the chi-square test are not tenable.

Determined using T-scores (higher T-score indicates better QoL) from the PROMIS v2.0 Brief Sexual Function and Satisfaction (Male) form and comparing T-score between patients receiving flibanserin and patients receiving placebo.

Toxicity will be assessed by a physician investigator and scored using the CTCAE v5.0 scale.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors	NCT03707340	Breast Cancer Hyposexual Desi...	Flibanserin Pil...	21 Years -	Memorial Sloan Kettering Cancer Center
A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors	NCT03707340	Breast Cancer Hyposexual Desi...	Flibanserin Pil...	21 Years -	Memorial Sloan Kettering Cancer Center
Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer	NCT04743934	Prostate Adenoc...	Flibanserin 100... Placebo Androgen depriv...	18 Years -	University of Alabama at Birmingham

Spots Global Cancer Trial Database for flibanserin

Every month we try and update this database with for flibanserin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for flibanserin

Every month we try and update this database with for flibanserin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for flibanserin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.