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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: Completed Early Phase 1 study of Breast Cancer and Dyspareunia, sponsored by Creighton University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Female Sexual Function Index (FSFI) questionnaire was administered to participants prior to starting vaginal testosterone therapy and the survey was repeated after using the study drug for 4 weeks. The participants served as their own controls. The FSFI assesses six domains of sexual functioning (desire, arousal, lubrication, orgasm, satisfaction, and pain) over the past 4 weeks. The sum of all domain scores equals the total FSFI score. The total FSFI score ranges from 2-36 and a total FSFI
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 |
What the finished NCT01697345 record still lists
NCT01697345 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01697345's enrollment target sits among peer trials
12 1167th of 1224 higher than 54 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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