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Trial Outcomes & Findings for Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism (NCT NCT00206375)

NCT ID: NCT00206375

Last Updated: 2020-10-30

Results Overview

The study was terminated due to insufficient funds. The study was terminated and the study PI has left the institution. All efforts to locate the study PI have been exhausted and the data is no longer available and cannot be reported.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

16 participants

Primary outcome timeframe

When bones are fused

Results posted on

2020-10-30

Participant Flow

Participant milestones

Participant milestones
Measure
Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro
Group 1 will be treated only with Synthroid. Long term hypothyroidism, treated with thyroxine alone (control group)
Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa
Group 2 will be treated with Growth hormone, synthroid, and lupron. Growth hormone: Growth hormone + Synthroid + Lupron Growth hormone treatment and puberty: Lupron once a month and growth hormone daily. Long term hypothyroidism, treated with thyroxine, GH and GnRHa
Short Term Hypothyroidism, Treated With Thyroxine (Control 2)
Group 3 will have acute hypothyroidism and will serve as controls. Short term hypothyroidism, treated with thyroxine (control group)
Overall Study
STARTED
6
3
7
Overall Study
COMPLETED
3
1
3
Overall Study
NOT COMPLETED
3
2
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro
Group 1 will be treated only with Synthroid. Long term hypothyroidism, treated with thyroxine alone (control group)
Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa
Group 2 will be treated with Growth hormone, synthroid, and lupron. Growth hormone: Growth hormone + Synthroid + Lupron Growth hormone treatment and puberty: Lupron once a month and growth hormone daily. Long term hypothyroidism, treated with thyroxine, GH and GnRHa
Short Term Hypothyroidism, Treated With Thyroxine (Control 2)
Group 3 will have acute hypothyroidism and will serve as controls. Short term hypothyroidism, treated with thyroxine (control group)
Overall Study
Lost to Follow-up
1
0
0
Overall Study
Withdrawal by Subject
2
1
3
Overall Study
Study terminated due to lack of funds
0
1
1

Baseline Characteristics

Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro
n=6 Participants
Group 1 will be treated only with Synthroid. Long term hypothyroidism, treated with thyroxine alone (control group)
Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa
n=3 Participants
Group 2 will be treated with Growth hormone, synthroid, and lupron. Growth hormone: Growth hormone + Synthroid + Lupron Growth hormone treatment and puberty: Lupron once a month and growth hormone daily. Long term hypothyroidism, treated with thyroxine, GH and GnRHa
Short Term Hypothyroidism, Treated With Thyroxine (Control 2)
n=7 Participants
Group 3 will have acute hypothyroidism and will serve as controls. Short term hypothyroidism, treated with thyroxine (control group)
Total
n=16 Participants
Total of all reporting groups
Age, Categorical
<=18 years
6 Participants
n=5 Participants
3 Participants
n=7 Participants
7 Participants
n=5 Participants
16 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
3 Participants
n=7 Participants
7 Participants
n=5 Participants
15 Participants
n=4 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Race/Ethnicity, Customized
Non-Hispanic White
2 Participants
n=5 Participants
2 Participants
n=7 Participants
6 Participants
n=5 Participants
10 Participants
n=4 Participants
Race/Ethnicity, Customized
Hispanic
3 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
5 Participants
n=4 Participants
Race/Ethnicity, Customized
Black
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race/Ethnicity, Customized
Asian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Race/Ethnicity, Customized
Other
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Height (cm)
124.5 cm
STANDARD_DEVIATION 7.2 • n=5 Participants
121.3 cm
STANDARD_DEVIATION 10.5 • n=7 Participants
142.3 cm
STANDARD_DEVIATION 11.4 • n=5 Participants
131.7 cm
STANDARD_DEVIATION 13.4 • n=4 Participants

PRIMARY outcome

Timeframe: When bones are fused

Population: n/a. The study was terminated due to insufficient funds.The study was terminated and the study PI has left the institution. All efforts to locate the study PI have been exhausted and the data is no longer available and cannot be reported

The study was terminated due to insufficient funds. The study was terminated and the study PI has left the institution. All efforts to locate the study PI have been exhausted and the data is no longer available and cannot be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: When bones are fused

Population: study was terminated due to insufficient funds. The study was terminated and the study PI has left the institution. All efforts to locate the study PI have been exhausted and the data is no longer available and cannot be reported

The study was terminated due to insufficient funds. The study was terminated and the study PI has left the institution. All efforts to locate the study PI have been exhausted and the data is no longer available and cannot be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: no time frame

Population: study was terminated due to insufficient funds. The study was terminated and the study PI has left the institution. All efforts to locate the study PI have been exhausted and the data is no longer available and cannot be reported.

The study was terminated due to insufficient funds. The study was terminated and the study PI has left the institution. All efforts to locate the study PI have been exhausted and the data is no longer available and cannot be reported.

Outcome measures

Outcome data not reported

Adverse Events

Long Term Hypothyroidism, Treated With Thyroxine Alone (Contro

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

Long Term Hypothyroidism, Treated With Thyroxine, GH and GnRHa

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

Short Term Hypothyroidism, Treated With Thyroxine (Control 2)

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. MJ Redondo (designated by the institution to enter results)

Texas Children's Hospital, Baylor College of Medicine

Phone: 832-822-1019

Results disclosure agreements

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