Trial · NCT00064987
Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men With Hypogonadism
NCT00064987, Phase 2, Terminated, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); results first posted 2017-07-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men With Hypogonadism. Trials, record NCT00064987. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00064987
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men With Hypogonadism
- NCT number
- NCT00064987
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Conditions
- Hypogonadism, Kallmann Syndrome
- Interventions
- Testicular biopsy, gonadotropin releasing hormone (GnRH), follicle stimulating hormone (FSH)
- First posted
- 2003-07-17
- Last updated
- 2017-07-07
- Results first posted
- 2017-07-07
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | LH | month 4 of GnRH treatment | Average Luteinizing Hormone levels after treatment. |
| Primary | FSH | month 4 of GnRH treatment | Average Follicle Stimulating Hormone levels after treatment. |
| Primary | Testosterone | month 4 of GnRH treatment | Average Testosterone levels after treatment. |
| Primary | Inhibin B | month 4 of GnRH treatment | Average Inhibin B Levels after treatment. |
| Primary | Testicular Size (Volume) | at baseline and month 4 of GnRH treatment | Average testicular volume after treatment. |
| Primary | Sperm Count | month 4 of GnRH treatment | Average sperm count after treatment. |
| Secondary | Fertility | 24 months | Participants actively seeking to conceive. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | LH | month 4 of GnRH treatment | IU/L | MEAN | |
| PRIMARY | FSH | month 4 of GnRH treatment | IU/L | MEAN | |
| PRIMARY | Testosterone | month 4 of GnRH treatment | ng/dL | MEAN | |
| PRIMARY | Inhibin B | month 4 of GnRH treatment | pg/mL | MEAN | |
| PRIMARY | Testicular Size (Volume) | at baseline and month 4 of GnRH treatment | mL | MEAN | |
| PRIMARY | Sperm Count | month 4 of GnRH treatment | 10^6 sperms/mL | MEAN | |
| SECONDARY | Fertility | 24 months | 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 | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| LH | Group 1 (FSH) | 12.7 | Standard Deviation .5 | IU/L | |
| LH | Group 2 (GnRH) | 16.5 | Standard Deviation .7 | IU/L | |
| FSH | Group 1 (FSH) | 9.9 | Standard Deviation .4 | IU/L | |
| FSH | Group 2 (GnRH) | 15.6 | Standard Deviation 1.1 | IU/L | |
| Testosterone | Group 1 (FSH) | 299 | Standard Deviation 14 | ng/dL | |
| Testosterone | Group 2 (GnRH) | 330 | Standard Deviation 15 | ng/dL | |
| Inhibin B | Group 1 (FSH) | 110 | Standard Deviation 5 | pg/mL | |
| Inhibin B | Group 2 (GnRH) | 74 | Standard Deviation 4 | pg/mL | |
| Testicular Size (Volume) | Group 1 (FSH) | Before Treatment | 1.1 | Standard Deviation .2 | mL |
| Testicular Size (Volume) | Group 2 (GnRH) | Before Treatment | .8 | Standard Deviation .2 | mL |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 (FSH) | 10 | |
| Overall Study | STARTED | Group 2 (GnRH) | 6 | |
| Overall Study | COMPLETED | Group 1 (FSH) | 7 | |
| Overall Study | COMPLETED | Group 2 (GnRH) | 6 | |
| Overall Study | NOT COMPLETED | Group 1 (FSH) | 3 | |
| Overall Study | NOT COMPLETED | Group 2 (GnRH) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 (FSH) | 0 | 10 |
| Total, all-cause mortality | Group 2 (GnRH) | 0 | 6 |
| Total, other adverse events | Group 1 (FSH) | 0 | 10 |
| Total, other adverse events | Group 2 (GnRH) | 0 | 6 |
| Total, serious adverse events | Group 1 (FSH) | 0 | 10 |
| Total, serious adverse events | Group 2 (GnRH) | 0 | 6 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U54HD028138 | Harvard Reproductive Endocrine Sciences Center | CROWLEY, WILLIAM FRANCIS | MASSACHUSETTS GENERAL HOSPITAL | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2000 to 2013 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1 (FSH) vs Group 2 (GnRH): Fertility | Trial comparisons |
| Group 1 (FSH) vs Group 2 (GnRH): deaths from any cause | Trial comparisons |
| Group 1 (FSH) vs Group 2 (GnRH): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00064987
GET https://conductscience.org/api/trials/v1/NCT00064987/registered