Trials Sponsors Conditions Drugs Pricing

Conditions

Breast Cancer Hyposexual Desire Disorder

Keywords

tamoxifenFlibanserinhyposexual desire disorder

Outcome Measures

Primary Outcomes (2)

Discontinuation rate of flibanserin in women with breast cancer on Tamoxifen with disease or medical induced hypoactive sexual desire disorder
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.
1 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of flibanserin
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.
1 year

Study Arms (1)

Breast Cancer Pts with hyposexual desire disorder/HSDD

EXPERIMENTAL

Drug: Flibanserin Pill

Interventions

Flibanserin PillDrug

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.

Breast Cancer Pts with hyposexual desire disorder/HSDD

Eligibility Criteria

Age21 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Women age 21 and older
Able to swallow tablets

Sponsors & Collaborators

Memorial Sloan Kettering Cancer Center
Otherlead

Study Sites (7)

Norwalk Hospital

Norwalk, Connecticut, 06850, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Memorial Sloan Kettering Cancer Center @ Commack

Commack, New York, 11725, United States

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Memorial Sloan - Kettering Cancer Center

New York, New York, 10021, United States

Memorial Sloan Kettering Nassau

MeSH Terms

Conditions

Breast Neoplasms

Interventions

flibanserin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Shari Goldfarb, MD
Memorial Sloan Kettering Cancer Center
PRINCIPAL INVESTIGATOR

Enrollment

43 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

October 16, 2018

Study Start

September 14, 2018

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Breast Cancer Pts with hyposexual desire disorder/HSDD

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Breast Cancer Pts with hyposexual desire disorder/HSDD

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations