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


Phase 0
50 Years
N/A
Not Enrolling
Female
Breast Cancer, Vaginal Dryness, Dyspareunia, Sexual Health Quality of Life

Thank you

Trial Information

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


Inclusion Criteria:



- Women with breast cancer

- Currently taking an aromatase inhibitor

- Age > 50 years of age

- Postmenopausal, or two years since last menstrual cycle

- Urogenital/vulvovaginal symptoms such as vaginal dryness and pain with intercourse

- Changes in sexual health quality of life/sexual functioning since starting AI therapy

Exclusion Criteria:

- The use of other treatments for breast cancer such as chemotherapy or radiation
within the past 12 months

- A known sensitivity to medications containing testosterone

- The use of exogenous HRT in the past three months, including systemic and local
estrogen or testosterone therapy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the effectiveness of a testosterone vaginal cream on the reported symptoms of vaginal dryness, pain with intercourse (dyspareunia), and sexual health quality of life related to aromatase inhibitor therapy in women with breast cancer.

Outcome Time Frame:

4 weeks

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

MelissaDahir

NCT ID:

NCT01697345

Start Date:

February 2013

Completion Date:

May 2013

Related Keywords:

  • Breast Cancer
  • Vaginal Dryness
  • Dyspareunia
  • Sexual Health Quality of Life
  • Vaginal Testosterone
  • Vaginal atrophy
  • Female Sexual Dysfunction
  • Aromatase Inhibitors
  • Breast Neoplasms
  • Dyspareunia

Name

Location

Nebraska Cancer Specialists/Midwest Cancer Center - LegacyOmaha, Nebraska  68130