Ovarian Aging in Low Grade Glioma (LGG) Treated With Temozolomide (OVA-LGG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01452854|
Recruitment Status : Terminated (Low recruitment, sponsor withdrew funding.)
First Posted : October 17, 2011
Results First Posted : August 28, 2014
Last Update Posted : August 28, 2014
|Condition or disease|
|Low Grade Glioma|
Understanding how Temozolomide influences ovarian aging would be important information for physicians to predict the possibility of infertility (the inability to become pregnant) following recovery from Temozolomide treatment. Physicians would like to provide better individualized recommendations for cancer patients regarding timing of planned treatment and future pregnancy.
We will do this by comparing data from the women being treated for Low Grade Glioma with Temozolomide to a similar group of women who have been unaffected by cancer or cancer treatment.
|Study Type :||Observational|
|Actual Enrollment :||2 participants|
|Official Title:||Ovarian Aging in Women Newly Diagnosed With Low Grade Glioma Treated With Temozolomide (Temodar®)|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).
- Ovarian Aging (AFC and Hormones) [ Time Frame: Every 3 months for 1 year ]Transvaginal Ultrasound will be use to measure Antral Follicle Counts (AFC) and blood will be drawn to measure hormones (FSH, LH, estradiol, estrone, AMH, SHBG, testosterone, and inhibin B).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452854
|United States, California|
|UCSF Center for Reproductive Health|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Mitchell Rosen, MD||UCSF Center for Reproductive Health and Fertility Preservation|
|Study Director:||Michael Prados, MD||UCSF Department of Neurological Surgery and Helen Diller Comprehensive Cancer Center|