CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 12 enrolled
Drug / intervention
Testosteronedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01697345
NCT01697345Early Ph 1Completed

Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: A Pilot Study on the Effects of Vaginal Testosterone Therapy

Creighton University·interventional·Posted Oct 2, 2012·Updated Jan 24, 2014

In Brief

A Early Phase 1 clinical trial evaluating Testosterone for Breast Cancer and 3 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed Summary

It is well documented that women who have breast cancer may experience a decrease in quality of life and sexual functioning due to side effects from adjuvant endocrine therapy, typically aromatase inhibitors (AIs). Women taking AIs are more likely to report unpleasant urogenital and vaginal symptoms due to the physiologic suppression of estradiol. This treatment can impair sexual functioning and cause a decreased sexual health quality of life. At the present time, there are no Food and Drug Administration (FDA) approved medications for the vulvovaginal or sexual side effects related to the use of AIs. The lack of treatment options is concerning because the number of women diagnosed with breast cancer continues to increase; their longevity, also, continues to increase with the use of newer adjuvant chemotherapies. Local health care practitioners have observed that the benefits of vaginal testosterone for sexual health in breast cancer survivors are similar to the benefits of vaginal estrogen in women without breast cancer. The purpose of this study is to evaluate the impact of using a daily compounded vaginal testosterone cream for 4 weeks (28 days) on breast cancer survivor's reported experience of vulvovaginal symptoms accompanying the use of AIs and their associated quality of life and sexual functioning.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2, 2012
Enrollment StartFeb 1, 2013
Primary CompletionApr 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.8 years ago

Interventions

Testosteronedrug