Idiopathic Hypogonadotropic HypogonadismPhase 4NCT02310074
Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism
A Phase 4 study testing Pulsatile Gonadotropin Releasing Hormone, Human chorionic gonadotropin and Urinary Follicle-Stimulating Hormone in people with Idiopathic Hypogonadotropic Hypogonadism, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy and pulsed infusion of gonadotropin releasing hormone (GnRH).In the present study, we compared the different efficacy and safety of pulsatile… Read more about this study
- Who is it for?
- Ages 16 to 35 years, men only
- Conditions the study is for
- Idiopathic Hypogonadotropic Hypogonadism
- What is being tested?
- Pulsatile Gonadotropin Releasing Hormone, Human chorionic gonadotropin and Urinary Follicle-Stimulating Hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age greater than 16 yr
- Diagnosed as idiopathic hypogonadotropic hypogonadism with clinical signs or symptoms of hypogonadism
- Hypogonadal serum testosterone levels (<166ng/dl) in the presence of low or normal gonadotropins
- Normal levels of other anterior pituitary hormones
- Normal MRI scans of the hypothalamo-pituitary region
- Had discontinued any prior treatment (testosterone or gonadotropin therapy) for at least three months before enrollment
Who cannot join
- With any significant medical condition (including malignant disease), laboratory abnormality, or psychiatric disorders that will prevent the subject from participating in the study
- Congenital hypopituitarism
- Any medical or surgical conditions possibly affecting the experiment result
- Any clinically significant allergic diseases or allergic to the study drugs
- Recently drug or alcohol abuse(>35unit/week,1unit=8 g alcohol@1 standard drink@250ml beer@140ml wine@25ml strong alcohol drink like whiskey.)
About this study
Official title: Study on the Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism
Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy and pulsed infusion of gonadotropin releasing hormone (GnRH).In the present study, we compared the different efficacy and safety of pulsatile GnRH pump therapy with combination gonadotropin therapy on fertility and sexual development in male patients with IHH.
Read the detailed description
Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy and pulsed infusion of gonadotropin releasing hormone (GnRH).In the present study, we compared the different efficacy and safety of pulsatile GnRH pump therapy with combination gonadotropin therapy on fertility and sexual development in male patients with IHH.
The primary endpoint was the achievement of pregnancy in female partner. Secondary endpoints were time to actual attainment of various sperm thresholds: sperm concentration>0*10^6/ml , >1.0 *10^6/ml and >15 *10^6/ml, respectively.
The clinical and laboratory characteristics including testicular and prostatic volume, Tanner stage for pubic hair and genital, serum hormone levels [especially serum testosterone,luteinizing hormone (LH) , and Follicle-Stimulating Hormone (FSH) levels], sperm concentration per ejaculate, and adverse events at baseline and at the end of treatment were also evaluated.
- Conditions
- Idiopathic Hypogonadotropic Hypogonadism
- Being tested
- Pulsatile Gonadotropin Releasing Hormone, Human chorionic gonadotropin, Urinary Follicle-Stimulating Hormone
- Medical subject headings
- Idiopathic Hypogonadotropic Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsatile Gonadotropin Releasing HormoneDrug
Also called Pulsatile GnRH pump
Human chorionic gonadotropinDrug
Human chorionic gonadotropin (hCG)
Urinary Follicle-Stimulating HormoneDrug
Urinary Follicle-Stimulating Hormone (uFSH)
| Study group | Role | What they receive |
|---|---|---|
| Pulsatile Gonadotropin Releasing Hormone | Experimental | Pulsatile Gonadotropin Releasing Hormone: subjects in the GnRH group initiated a regimen of pulsatile GnRH administered subcutaneously via a portable infusion pump for 18 months. Receives: Drug: Pulsatile Gonadotropin Releasing Hormone |
| combination gonadotropin therapy | Active comparator | combined human chorionic gonadotropin (hCG)/urinary Follicle-Stimulating Hormone (uFSH) therapy:HCG treatment was maintained alone for 6 months and then uFSH was added for the next 12 months Receives: Drug: Human chorionic gonadotropin; Drug: Urinary Follicle-Stimulating Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy in the female partner
Measured: 18 months
Secondary outcomes (3)
first appearance of sperm (month after treatment)
Measured: 18 months
first time with sperm density>1*10^6/ml（month after treatment）
Measured: 18 months
first time with sperm density>15*10^6/ml（month after treatment）
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startJan 2010
- Primary completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
- Investigators
- Guang Ning, MD, PHD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310074
- Sponsor's protocol ID
- ruijin-GnRH pump-002
- Status last verified
- Dec 2014
- First submitted
- 3 Dec 2014
- Last updated
- 3 Feb 2015
- Results posted
- No
Publications
Yang YY, Zheng SC, Wang WC, Yang ZW, Shan C, Zhang YW, Qi Y, Chen YH, Gu WQ, Wang WQ, Zhao HY, Liu JM, Sun SY. Osteocalcin Levels in Male Idiopathic Hypogonadotropic Hypogonadism: Relationship With the Testosterone Secretion and Metabolic Profiles. Front Endocrinol (Lausanne). 2019 Oct 11;10:687. doi: 10.3389/fendo.2019.00687. eCollection 2019.
PubMed 31681165
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism
- ClinicalTrials.gov ID
- NCT02310074
- Acronym / sponsor ID
- ruijin-GnRH pump-002
- Conditions
- Idiopathic Hypogonadotropic Hypogonadism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2014 (actual)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy and pulsed infusion of gonadotropin releasing hormone (GnRH).In the present study, we compared the different efficacy and safety of pulsatile GnRH pump therapy with combination gonadotropin therapy on fertility and sexual development in male patients with IHH.
Detailed description
Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy and pulsed infusion of gonadotropin releasing hormone (GnRH).In the present study, we compared the different efficacy and safety of pulsatile GnRH pump therapy with combination gonadotropin therapy on fertility and sexual development in male patients with IHH.
The primary endpoint was the achievement of pregnancy in female partner. Secondary endpoints were time to actual attainment of various sperm thresholds: sperm concentration>0*10^6/ml , >1.0 *10^6/ml and >15 *10^6/ml, respectively.
The clinical and laboratory characteristics including testicular and prostatic volume, Tanner stage for pubic hair and genital, serum hormone levels [especially serum testosterone,luteinizing hormone (LH) , and Follicle-Stimulating Hormone (FSH) levels], sperm concentration per ejaculate, and adverse events at baseline and at the end of treatment were also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsatile Gonadotropin Releasing Hormone | Experimental | Drug: Pulsatile Gonadotropin Releasing HormonePulsatile Gonadotropin Releasing Hormone: subjects in the GnRH group initiated a regimen of pulsatile GnRH administered subcutaneously via a portable infusion pump for 18 months. |
| combination gonadotropin therapy | Active comparator | Drug: Human chorionic gonadotropin, Drug: Urinary Follicle-Stimulating Hormonecombined human chorionic gonadotropin (hCG)/urinary Follicle-Stimulating Hormone (uFSH) therapy:HCG treatment was maintained alone for 6 months and then uFSH was added for the next 12 months |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age greater than 16 yr
- Diagnosed as idiopathic hypogonadotropic hypogonadism with clinical signs or symptoms of hypogonadism
- Hypogonadal serum testosterone levels (<166ng/dl) in the presence of low or normal gonadotropins
- Normal levels of other anterior pituitary hormones
- Normal MRI scans of the hypothalamo-pituitary region
Key exclusion criteria (5 listed)
- With any significant medical condition (including malignant disease), laboratory abnormality, or psychiatric disorders that will prevent the subject from participating in the study
- Congenital hypopituitarism
- Any medical or surgical conditions possibly affecting the experiment result
- Any clinically significant allergic diseases or allergic to the study drugs
- Recently drug or alcohol abuse(>35unit/week,1unit=8 g alcohol@1 standard drink@250ml beer@140ml wine@25ml strong alcohol drink like whiskey.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsatile Gonadotropin Releasing HormoneAlso: Pulsatile GnRH pump | Drug | Pulsatile Gonadotropin Releasing Hormone |
| Human chorionic gonadotropinHuman chorionic gonadotropin (hCG) | Drug | combination gonadotropin therapy |
| Urinary Follicle-Stimulating HormoneUrinary Follicle-Stimulating Hormone (uFSH) | Drug | combination gonadotropin therapy |
Primary outcome
pregnancy in the female partner
Time frame: 18 months
3 secondary outcomes
first appearance of sperm (month after treatment)
Time frame: 18 months
first time with sperm density>1*10^6/ml（month after treatment）
Time frame: 18 months
first time with sperm density>15*10^6/ml（month after treatment）
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
- Derived from this study: PubMed 31681165Yang YY, Zheng SC, Wang WC, Yang ZW, Shan C, Zhang YW, Qi Y, Chen YH, Gu WQ, Wang WQ, Zhao HY, Liu JM, Sun SY. Osteocalcin Levels in Male Idiopathic Hypogonadotropic Hypogonadism: Relationship With the Testosterone Secretion and Metabolic Profiles. Front Endocrinol (Lausanne). 2019 Oct 11;10:687. doi: 10.3389/fendo.2019.00687. eCollection 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guang Ning, MD, PHD principal investigator
Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pulsatile Gonadotropin Releasing Hormone, Human chorionic gonadotropin and Urinary Follicle-Stimulating Hormone in people with Idiopathic Hypogonadotropic Hypogonadism, run by Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy in the female partner (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02310074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2015.