Trial Outcomes & Findings for Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men With Hypogonadism (NCT NCT00064987)
NCT ID: NCT00064987
Last Updated: 2017-07-07
Results Overview
Average Luteinizing Hormone levels after treatment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
month 4 of GnRH treatment
Results posted on
2017-07-07
Participant Flow
Two subjects were deemed ineligible for the study. One subject was lost to follow up before being assigned to Group 1 or Group 2.
Participant milestones
| Measure |
Group 1 (FSH)
Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
|
Group 2 (GnRH)
Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Group 1 (FSH)
Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
|
Group 2 (GnRH)
Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
0
|
Baseline Characteristics
Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men With Hypogonadism
Baseline characteristics by cohort
| Measure |
Group 1 (FSH)
n=10 Participants
Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
|
Group 2 (GnRH)
n=6 Participants
Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: month 4 of GnRH treatmentAverage Luteinizing Hormone levels after treatment.
Outcome measures
| Measure |
Group 1 (FSH)
n=7 Participants
Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
|
Group 2 (GnRH)
n=6 Participants
Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
|
|---|---|---|
|
LH
|
12.7 IU/L
Standard Deviation .5
|
16.5 IU/L
Standard Deviation .7
|
PRIMARY outcome
Timeframe: month 4 of GnRH treatmentAverage Follicle Stimulating Hormone levels after treatment.
Outcome measures
| Measure |
Group 1 (FSH)
n=7 Participants
Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
|
Group 2 (GnRH)
n=6 Participants
Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
|
|---|---|---|
|
FSH
|
9.9 IU/L
Standard Deviation .4
|
15.6 IU/L
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: month 4 of GnRH treatmentAverage Testosterone levels after treatment.
Outcome measures
| Measure |
Group 1 (FSH)
n=7 Participants
Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
|
Group 2 (GnRH)
n=6 Participants
Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
|
|---|---|---|
|
Testosterone
|
299 ng/dL
Standard Deviation 14
|
330 ng/dL
Standard Deviation 15
|
PRIMARY outcome
Timeframe: month 4 of GnRH treatmentAverage Inhibin B Levels after treatment.
Outcome measures
| Measure |
Group 1 (FSH)
n=7 Participants
Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
|
Group 2 (GnRH)
n=6 Participants
Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
|
|---|---|---|
|
Inhibin B
|
110 pg/mL
Standard Deviation 5
|
74 pg/mL
Standard Deviation 4
|
PRIMARY outcome
Timeframe: at baseline and month 4 of GnRH treatmentAverage testicular volume after treatment.
Outcome measures
| Measure |
Group 1 (FSH)
n=7 Participants
Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
|
Group 2 (GnRH)
n=6 Participants
Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
|
|---|---|---|
|
Testicular Size (Volume)
Before Treatment
|
1.1 mL
Standard Deviation .2
|
.8 mL
Standard Deviation .2
|
|
Testicular Size (Volume)
After Treatment
|
9.3 mL
Standard Deviation 1.7
|
6.6 mL
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: month 4 of GnRH treatmentAverage sperm count after treatment.
Outcome measures
| Measure |
Group 1 (FSH)
n=7 Participants
Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
|
Group 2 (GnRH)
n=6 Participants
Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
|
|---|---|---|
|
Sperm Count
|
5.8 10^6 sperms/mL
Standard Deviation 2.3
|
2.6 10^6 sperms/mL
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Four subjects in Group 1 and two subjects in Group 2 were actively trying to conceive. Fertility was not tracked in subjects not trying to conceive.
Participants actively seeking to conceive.
Outcome measures
| Measure |
Group 1 (FSH)
n=4 Participants
Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
|
Group 2 (GnRH)
n=2 Participants
Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
|
|---|---|---|
|
Fertility
|
4 Participants
|
1 Participants
|
Adverse Events
Group 1 (FSH)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 (GnRH)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place