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Trial Outcomes & Findings for Ovarian Aging in Low Grade Glioma (LGG) Treated With Temozolomide (NCT NCT01452854)

NCT ID: NCT01452854

Last Updated: 2022-07-08

Results Overview

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).

Recruitment status

TERMINATED

Target enrollment

2 participants

Primary outcome timeframe

Every 3 months for 1 year

Results posted on

2022-07-08

Participant Flow

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

Participant milestones

Participant milestones
Measure
Cancer
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 Study
STARTED
2
Overall Study
COMPLETED
2
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ovarian Aging in Low Grade Glioma (LGG) Treated With Temozolomide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cancer
n=2 Participants
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).
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=99 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
Sex: Female, Male
Female
2 Participants
n=99 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
Region of Enrollment
United States
2 participants
n=99 Participants

PRIMARY outcome

Timeframe: Every 3 months for 1 year

Population: Data collection was terminated and analyses were not performed due to low enrollment

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).

Outcome measures

Outcome data not reported

Adverse Events

Cancer

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mitchell Rosen

UCSF

Phone: 415-353-7394

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place