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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
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Low Grade Glioma
Enrollment 2
Recruitment Details Low recruitment necessitated the closing of the study. No results available.
Pre-assignment Details  
Arm/Group Title Cancer
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Cancer
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
Low recruitment necessitated the closing of the study. No results available.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
2
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Ovarian Aging (AFC and Hormones)
Hide Description 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).
Time Frame Every 3 months for 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data collection was terminated and analyses were not performed due to low enrollment
Arm/Group Title Cancer
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description This is a non-treatment study so there was no reporting of AEs. Adverse events due to temozolomide treatment, if any, were handled as per institutional guidelines and the Cancer Center protocols.
 
Arm/Group Title Cancer
Hide Arm/Group Description

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).

Low recruitment necessitated the closing of the study. No results available.

All-Cause Mortality
Cancer
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cancer
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cancer
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Mitchell Rosen
Organization: UCSF
Phone: 415-353-7394
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01452854     History of Changes
Other Study ID Numbers: UCSF 10-03288
First Submitted: October 12, 2011
First Posted: October 17, 2011
Results First Submitted: June 10, 2014
Results First Posted: August 28, 2014
Last Update Posted: August 28, 2014