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NCT01603303 · ClinicalTrials.gov registry record · Phase 2
Preventing Sexual Dysfunction With Aromatase Inhibitors
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 187
- Enrollment target
NCT01603303: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01603303 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 187 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01603303, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 187 participants
- Enrollment target
Study Summary
Aromatase inhibitors (AIs) are used to try to stop breast cancer from forming or returning after treatment in women who are in menopause and who had breast cancer that was sensitive to the hormone estrogen. The goal of this study is to learn if it is possible to prevent some AI side effects, particularly problems with vaginal dryness and pain during sexual activity. Researchers also want to compare 2 new vaginal moisturizers to see if using them regularly helps women avoid vaginal dryness. Researchers want to see if preventing these side effects will decrease the number of women who stop taking AIs due to the side effects they cause.
Primary Outcome
The primary outcome measure will be the total score from the Female Sexual Function Index (FSFI), which is calculated according to a standard scoring algorithm and has a well-validated cut-off score of 26.55 or below indicating sexual dysfunction. FSFI subscale scores will also be calculated and analyzed.
Interventions
- BEHAVIORAL Questionnaires
- OTHER Education Materials
- OTHER Luvena
- OTHER Hyalo-Gyn
- OTHER Vaginal Lubricant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2012-12-05 |
| Est. Completion | 2017-08-11 |
| Phase | Phase 2 |
What the finished NCT01603303 record still lists
NCT01603303 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher).
The record links to 0 conditions, and to 5 interventions - of which Questionnaires is the first listed.
NCT01603303 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01603303 about?
NCT01603303 is a clinical study titled "Preventing Sexual Dysfunction With Aromatase Inhibitors". Aromatase inhibitors (AIs) are used to try to stop breast cancer from forming or returning after treatment in women who are in menopause and who had breast cancer that was sensitive to the hormone estrogen. The goal of this study is to learn if it is possible to prevent some AI side effects, partic...
What is the current status of trial NCT01603303?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 187 participants. The study started on 2012-12-05. Estimated completion is 2017-08-11.
What interventions are being tested in trial NCT01603303?
The interventions under investigation include: Questionnaires (BEHAVIORAL), Education Materials (OTHER), Luvena (OTHER), Hyalo-Gyn (OTHER), Vaginal Lubricant (OTHER).
Who is sponsoring clinical trial NCT01603303?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01603303's enrollment target sits among peer trials
187 357th of 2000 higher than 1,644 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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