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NCT01697345 · ClinicalTrials.gov registry record · Early Phase 1
Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy
A Early Phase 1 study of Breast Cancer and Dyspareunia, sponsored by Creighton University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT01697345 is a Early Phase 1 study of Breast Cancer and Dyspareunia that has completed, run by Creighton University. The registered enrollment target is 12 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01697345, a Early Phase 1 study of Breast Cancer and Dyspareunia, has completed, sponsored by Creighton University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Testosterone
Study Locations (1)
Nebraska
- Nebraska Cancer Specialists/Midwest Cancer Center - Legacy - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-02 |
| Est. Completion | 2013-05 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01697345
The ClinicalTrials.gov registry entry for NCT01697345 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The listed sponsor is Creighton University, which has 98 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Testosterone is the first listed.
NCT01697345 reports 1 study location spanning 1 distinct geographic area - top geographies include Nebraska.
Frequently Asked Questions
What is clinical trial NCT01697345 about?
NCT01697345 is a clinical study titled "Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy". 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...
What is the current status of trial NCT01697345?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2013-02. Estimated completion is 2013-05.
What conditions does trial NCT01697345 study?
This clinical trial studies the following conditions: Breast Cancer, Dyspareunia, Vaginal Dryness, Sexual Health Quality of Life.
What interventions are being tested in trial NCT01697345?
The interventions under investigation include: Testosterone (DRUG).
Who is sponsoring clinical trial NCT01697345?
This trial is sponsored by Creighton University, which has 98 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01697345 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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