Hypogonadotropic HypogonadismPhase 4NCT01403532
Sequential Therapy for Hypogonadotropic Hypogonadism
A Phase 4 study testing Traditional intervention for HH using HCG and FSH, Sequential intervention for HH using HCG and FSH and Sequential intervention for HH using HCG and FSH plus zinc in people with Hypogonadotropic Hypogonadism and Kallmann Syndrome, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The traditional therapy for induction of spermatogenesis in male hypogonadotropic hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until pregnancy occurs. Read more about this study
- Who is it for?
- Ages 16 to 45 years, men only
- Conditions the study is for
- Hypogonadotropic Hypogonadism, Kallmann Syndrome
- What is being tested?
- Traditional intervention for HH using HCG and FSH, Sequential intervention for HH using HCG and FSH and Sequential intervention for HH using HCG and FSH plus zinc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2009to Dec 2012
- 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 45 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical hypogonadotropic hypogonadism
- Hormonal levels: Testosterone < 1.8ng/ml, LH < 2-3 mIU/mL and FSH < 2-3 mIU/mL
- Infantile testis
- Delayed bone age
- Normal testing of the anterior pituitary gland
Who cannot join
- Prior therapy with HMG or FSH
- Severe dysfunction of live and kidney
- Cryptorchidism or no response to HCG stimulation experiment (Testosterone < 1.8ng/ml after HCG stimulation)
- Another pituitary hormonal deficiency
- Hypergonadotropic hypogonadism
- With abnormal karyotype
Trial locations and contacts
1 site in 1 country.
China1 site
Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Efficacy and Safety of Human Chorionic Gonadotropin (HCG) and Follicle Stimulating Hormone (FSH) in the Treatment of Hypogonadotropic Hypogonadism
The traditional therapy for induction of spermatogenesis in male hypogonadotropic hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until pregnancy occurs. Because of the high cost of hMG or FSH preparations and poor compliance, the investigators raise a new sequential therapeutic approach which can make the treatment more economic and tolerable. The zinc supplement will be also evaluated in patients in this study. This randomized, parallel, open, and multi-center study will compare the efficacy of traditional therapy with new therapy and evaluate the safety of the new protocol.
- Conditions
- Hypogonadotropic Hypogonadism, Kallmann Syndrome
- Being tested
- Traditional intervention for HH using HCG and FSH, Sequential intervention for HH using HCG and FSH, Sequential intervention for HH using HCG and FSH plus zinc
- Keywords
- Hypogonadotropic Hypogonadism, Kallmann Syndrome, LH, FSH
- Medical subject headings
- Hypogonadism, Kallmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional intervention for HH using HCG and FSHDrug
Also called Tranditional
Human chorionic gonadotropin(HCG),2000U,im,2 times/week, one year and a half; Follicle stimulating hormone(FSH),75U, im, 3 times/week, one year;
Sequential intervention for HH using HCG and FSHDrug
Also called Sequential
Human chorionic gonadotropin,2000U,im, 2 times/week, one and half a year Follicle stimulating hormone,75U,im,3 times/week, every other three months
Sequential intervention for HH using HCG and FSH plus zincDrug
Also called Sequential plus
Human chorionic gonadotropin,2000U,im,2 times/week, one year and a half Follicle stimulating hormone,75U, im, 3 times/week, every other three months Zinc gluconate 20mg,P.O, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Traditional | Active comparator | Not described Receives: Drug: Traditional intervention for HH using HCG and FSH |
| Sequential | Experimental | Not described Receives: Drug: Sequential intervention for HH using HCG and FSH |
| Sequential Plus | Experimental | Not described Receives: Drug: Sequential intervention for HH using HCG and FSH plus zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm density ≥1,000,000/ml
The sperm will be counted as equal or more than 1,000,000/ml under microscope for each subject.
Measured: One and a half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startSep 2009
- Primary completionDec 2012
- Study completionDec 2012
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 Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Ying Li, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xiao-Ying Li, MD,PhD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403532
- Sponsor's protocol ID
- CCEMD005
- Status last verified
- Feb 2014
- First submitted
- 1 Feb 2011
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang M, Tong G, Liu Y, Mu Y, Weng J, Xue Y, Luo Z, Xue Y, Shi L, Wu X, Sun S, Zhu Y, Cao Y, Zhang J, Huang H, Niu B, Li H, Guo Q, Gao Y, Li Z, Ning G, Zhu D, Li X; HHIS Study Group. Sequential Versus Continual Purified Urinary FSH/hCG in Men With Idiopathic Hypogonadotropic Hypogonadism. J Clin Endocrinol Metab. 2015 Jun;100(6):2449-55. doi: 10.1210/jc.2014-3802. Epub 2015 Mar 31.
PubMed 25825944
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Human Chorionic Gonadotropin (HCG) and Follicle Stimulating Hormone (FSH) in the Treatment of Hypogonadotropic Hypogonadism
- ClinicalTrials.gov ID
- NCT01403532
- Acronym / sponsor ID
- CCEMD005
- Conditions
- Hypogonadotropic Hypogonadism, Kallmann Syndrome
- Keywords
- Hypogonadotropic Hypogonadism, Kallmann Syndrome, LH, FSH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Jul 2011 (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.
The traditional therapy for induction of spermatogenesis in male hypogonadotropic hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until pregnancy occurs. Because of the high cost of hMG or FSH preparations and poor compliance, the investigators raise a new sequential therapeutic approach which can make the treatment more economic and tolerable. The zinc supplement will be also evaluated in patients in this study. This randomized, parallel, open, and multi-center study will compare the efficacy of traditional therapy with new therapy and evaluate the safety of the new protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional | Active comparator | Drug: Traditional intervention for HH using HCG and FSH |
| Sequential | Experimental | Drug: Sequential intervention for HH using HCG and FSH |
| Sequential Plus | Experimental | Drug: Sequential intervention for HH using HCG and FSH plus zinc |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Clinical hypogonadotropic hypogonadism
- Hormonal levels: Testosterone < 1.8ng/ml, LH < 2-3 mIU/mL and FSH < 2-3 mIU/mL
- Infantile testis
- Delayed bone age
- Normal testing of the anterior pituitary gland
Key exclusion criteria (6 listed)
- Prior therapy with HMG or FSH
- Severe dysfunction of live and kidney
- Cryptorchidism or no response to HCG stimulation experiment (Testosterone < 1.8ng/ml after HCG stimulation)
- Another pituitary hormonal deficiency
- Hypergonadotropic hypogonadism
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 |
|---|---|---|
| Traditional intervention for HH using HCG and FSHAlso: TranditionalHuman chorionic gonadotropin(HCG),2000U,im,2 times/week, one year and a half; Follicle stimulating hormone(FSH),75U, im, 3 times/week, one year; | Drug | Traditional |
| Sequential intervention for HH using HCG and FSHAlso: SequentialHuman chorionic gonadotropin,2000U,im, 2 times/week, one and half a year Follicle stimulating hormone,75U,im,3 times/week, every other three months | Drug | Sequential |
| Sequential intervention for HH using HCG and FSH plus zincAlso: Sequential plusHuman chorionic gonadotropin,2000U,im,2 times/week, one year and a half Follicle stimulating hormone,75U, im, 3 times/week, every other three months Zinc gluconate 20mg,P.O, twice daily | Drug | Sequential Plus |
Primary outcome
Sperm density ≥1,000,000/ml
Time frame: One and a half year
The sperm will be counted as equal or more than 1,000,000/ml under microscope for each subject.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
- Derived from this study: PubMed 25825944Zhang M, Tong G, Liu Y, Mu Y, Weng J, Xue Y, Luo Z, Xue Y, Shi L, Wu X, Sun S, Zhu Y, Cao Y, Zhang J, Huang H, Niu B, Li H, Guo Q, Gao Y, Li Z, Ning G, Zhu D, Li X; HHIS Study Group. Sequential Versus Continual Purified Urinary FSH/hCG in Men With Idiopathic Hypogonadotropic Hypogonadism. J Clin Endocrinol Metab. 2015 Jun;100(6):2449-55. doi: 10.1210/jc.2014-3802. Epub 2015 Mar 31.
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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.
Xiao-Ying Li, MD,PhD principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Traditional intervention for HH using HCG and FSH, Sequential intervention for HH using HCG and FSH and Sequential intervention for HH using HCG and FSH plus zinc in people with Hypogonadotropic Hypogonadism and Kallmann Syndrome, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sperm density ≥1,000,000/ml (time frame: One and a half year). 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 NCT01403532, 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 11 Feb 2014.