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NCT01384526 · ClinicalTrials.gov registry record
Investigating the Impact of Tamoxifen Therapy on Ovarian Aging
A clinical trial of Breast Cancer and Fertility, sponsored by University of California, San Francisco.
- Completed
- Registry status
- 266
- Enrollment target
- 1
- Study location
NCT01384526: Completed study of Breast Cancer and Fertility, sponsored by University of California, San Francisco.
NCT01384526 is a study of Breast Cancer and Fertility that has completed, run by University of California, San Francisco. The registered enrollment target is 266 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01384526, a study of Breast Cancer and Fertility, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- 266 participants
- Enrollment target
- 1
- Study location
Study Summary
Ovarian toxicity is a well-described side effect of traditional chemotherapy in premenopausal women receiving treatment for early stage breast cancer. However, the impact of long-term endocrine therapy on ovarian function is not established, and to our knowledge, has never been directly studied. Understanding the effects of hormone therapy on ovarian aging will help breast cancer patients of reproductive age make more informed and empowered decisions regarding their treatment. The purpose of this study is to explore the relationship between tamoxifen therapy and ovarian aging. Patients will be identified through the UCSF Cancer Registry and California Pacific Medical Center Cancer Registry and will be evaluated based on age and menopausal status. Women who read about the study from clinicaltrials.gov and contact the study coordinator will also be considered for enrollment. The age of menopause onset will be assessed through surveys and will be compared to the accepted national average age of natural menopause. Biomarkers of ovarian reserve will be assessed in premenopausal women between ages 25-45 and will be compared to those of healthy age- and ethnicity-matched premenopausal controls from an ongoing RO1- funded prospective longitudinal ovarian aging (OVA) study.
Primary Outcome
The primary aim of this study is to determine the mean age of menopause onset in a cohort of women who have completed a course of tamoxifen therapy and to compare this age with the accepted national average age of natural menopause. Age of menopause onset which is defined as the year of the last menstrual period minus patient's birth year.
Conditions Studied
Study Locations (1)
California
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 266 participants |
| Start Date | 2011-06 |
| Est. Completion | 2015-03 |
What the finished NCT01384526 record still lists
NCT01384526 is an observational study that tracks outcomes without assigning an intervention. The registered 266 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT01384526 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01384526 about?
NCT01384526 is a clinical study titled "Investigating the Impact of Tamoxifen Therapy on Ovarian Aging". Ovarian toxicity is a well-described side effect of traditional chemotherapy in premenopausal women receiving treatment for early stage breast cancer. However, the impact of long-term endocrine therapy on ovarian function is not established, and to our knowledge, has never been directly studied. Und...
What is the current status of trial NCT01384526?
This trial is currently completed. The enrollment target is 266 participants. The study started on 2011-06. Estimated completion is 2015-03.
What conditions does trial NCT01384526 study?
This clinical trial studies the following conditions: Breast Cancer, Fertility.
Who is sponsoring clinical trial NCT01384526?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01384526 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01384526's enrollment target sits among peer trials
266 309th of 1224 higher than 916 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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