Hypogonadotropic HypogonadismNCT02705014
Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome
A study testing Gonadotropin-releasing Hormone in people with Hypogonadotropic Hypogonadism, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Hypogonadotropic Hypogonadism
- What is being tested?
- Gonadotropin-releasing Hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Aug 2017
- Phase
- Interventional
- 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 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years or over male patients;
- Absent or incomplete puberty development;
- Serum testosterone values below 3.47 nmol/L by low or normal serum LH and FSH concentrations.
- at least two or more pituitary hormone deficiencies
- Brain MRI showed absent and thin pituitary stalk, or pituitary hypoplasia and/or ectopic posterior pituitary.
Who cannot join
- cryptorchidism history
- other causes of hypopituitarism or severe systemic disease
Trial locations and contacts
1 site in 1 country.
Xue-yan Wu contact
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy.
Read the detailed description
To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy. The hormonal response of the hypothalamic-pituitary-gonad axis was assessed after pulsatile GnRH replacement by measurement of serum T, LH and FSH. A standard seminal fluid analysis was performed in men who could produce an ejaculate.
- Conditions
- Hypogonadotropic Hypogonadism
- Being tested
- Gonadotropin-releasing Hormone
- Keywords
- pituitary stalk interruption syndrome, pulsatile GnRH therapy, hypogonadotropic hypogonadism, hypopituitarism
- Medical subject headings
- Hypogonadism, Hypopituitarism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonadotropin-releasing HormoneDrug
Also called Gonadorelin
A regimen of pulsatile GnRH (Fengyuan pharmaceutical company, Anhui province, China) administered subcutaneous via a portable infusion pump (Weichuang Medical Science Company, Shanghai city, China) at a 90-minute interval. The GnRH dosage was initially 10ug per pulse and was progressively adjusted to maintain serum testosterone levels at 6.94-17.35 nmol/L ( 200-500 ng/dL).
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | patients were administered with pulsatile gonadotropin-releasing hormone (GnRH )therapy for 12 months at an interval of 90 minutes.The GnRH dosage was initially 10ug per pulse and was progressively adjusted to maintain serum testosterone levels at 6.94-17.35 nmol/L. Receives: Drug: Gonadotropin-releasing Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum Luteinizing Hormone(LH) value
Luteinizing hormone (LH) is measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 1.24-8.62 IU/L. Initial efficacy is evaluated based on the values of serum LH and serum total testosterone. If a subject's serum LH value below 1.5 IU/L and serum total testosterone value below 100 ng/dL at 3m post treatment, it is defined as failure to pulsatile GnRH treatment and continuous treatment is stopped. Otherwise, pulsatile GnRH treatment is continued.
Measured: Baseline and at 1m,3m, 6m, 9m and 12m post treatment.
Change of serum Follicle-Stimulating Hormone (FSH) value
Follicle-stimulating hormone (FSH) are measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 1.27-19.26 IU/L.
Measured: Baseline and at 1m,3m, 6m, 9m and 12m post treatment.
Change of serum total testosterone value
Total testosterone levels are measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 175-781 ng/dL.Initial efficacy is evaluated based on the values of serum LH and serum totaltestosterone. If a subject's serum LH value below 1.5 IU/L and serum total testosterone value below 100 ng/dL at 3m post treatment, it is defined as failure to pulsatile GnRH treatment and continuous treatment is stopped. Otherwise, pulsatile GnRH treatment is continued.
Measured: Baseline and at 1m,3m, 6m, 9m and 12m post treatment.
Secondary outcomes (3)
Change of testicular volume
Testicular volumes are measured using Prader orchidometer. Prader orchidometer is a standard method to measure testicular volume. The normal range of testicular volume of each side in normal adult men is 15-25ml.
Measured: Baseline and at 1m,3m, 6m, 9m and 12m post treatment
Change of sperm counts by routine semen analysis
if a subject can produce an ejaculate, semen samples are collected by masturbation and analyzed according to the standard World Health Organization method.
Measured: Baseline and at 3m, 6m, 9m and 12m post treatment
the rate of impregnating subject's wife
For subjects who have sex partners, pregnancies are documented according to subjects' reports after treatment.
Measured: at 3m, 6m, 9m and 12m post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2016 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wuxueyan, Peking Union Medical College Hospital
- Investigators
- Xue-yan Wu, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705014
- Sponsor's protocol ID
- ZS-997
- Status last verified
- Mar 2016
- First submitted
- 22 Feb 2016
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Shao WM, Bai WJ, Chen YM, Liu L, Wang YJ. [Micropump infusion of gonadorelin in the treatment of hypogonadotropic hypogonadism in patients with pituitary stalk interruption syndrome: cases analysis and literature review]. Beijing Da Xue Xue Bao Yi Xue Ban. 2014 Aug 18;46(4):642-5. Chinese.
PubMed 25131486Zheng J, Mao J, Xu H, Wang X, Huang B, Liu Z, Cui M, Xiong S, Ma W, Min L, Kaiser UB, Nie M, Wu X. Pulsatile GnRH Therapy May Restore Hypothalamus-Pituitary-Testis Axis Function in Patients With Congenital Combined Pituitary Hormone Deficiency: A Prospective, Self-Controlled Trial. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2291-2300. doi: 10.1210/jc.2016-3990.
PubMed 28368486
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome
- ClinicalTrials.gov ID
- NCT02705014
- Acronym / sponsor ID
- ZS-997
- Conditions
- Hypogonadotropic Hypogonadism
- Keywords
- pituitary stalk interruption syndrome, pulsatile GnRH therapy, hypogonadotropic hypogonadism, hypopituitarism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 10 Mar 2016 (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.
To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy.
Detailed description
To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy. The hormonal response of the hypothalamic-pituitary-gonad axis was assessed after pulsatile GnRH replacement by measurement of serum T, LH and FSH. A standard seminal fluid analysis was performed in men who could produce an ejaculate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Gonadotropin-releasing Hormonepatients were administered with pulsatile gonadotropin-releasing hormone (GnRH )therapy for 12 months at an interval of 90 minutes.The GnRH dosage was initially 10ug per pulse and was progressively adjusted to maintain serum testosterone levels at 6.94-17.35 nmol/L. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 years or over male patients;
- Absent or incomplete puberty development;
- Serum testosterone values below 3.47 nmol/L by low or normal serum LH and FSH concentrations.
- at least two or more pituitary hormone deficiencies
- Brain MRI showed absent and thin pituitary stalk, or pituitary hypoplasia and/or ectopic posterior pituitary.
Key exclusion criteria (2 listed)
- cryptorchidism history
- other causes of hypopituitarism or severe systemic disease
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 |
|---|---|---|
| Gonadotropin-releasing HormoneAlso: GonadorelinA regimen of pulsatile GnRH (Fengyuan pharmaceutical company, Anhui province, China) administered subcutaneous via a portable infusion pump (Weichuang Medical Science Company, Shanghai city, China) at a 90-minute interval. The GnRH dosage was initially 10ug per pulse and was progressively adjusted to maintain serum testosterone levels at 6.94-17.35 nmol/L ( 200-500 ng/dL). | Drug | treatment group |
Primary outcome
Change of serum Luteinizing Hormone(LH) value
Time frame: Baseline and at 1m,3m, 6m, 9m and 12m post treatment.
Luteinizing hormone (LH) is measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 1.24-8.62 IU/L. Initial efficacy is evaluated based on the values of serum LH and serum total testosterone. If a subject's serum LH value below 1.5 IU/L and serum total testosterone value below 100 ng/dL at 3m post treatment, it is defined as failure to pulsatile GnRH treatment and continuous treatment is stopped. Otherwise, pulsatile GnRH treatment is continued.
Change of serum Follicle-Stimulating Hormone (FSH) value
Time frame: Baseline and at 1m,3m, 6m, 9m and 12m post treatment.
Follicle-stimulating hormone (FSH) are measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 1.27-19.26 IU/L.
Change of serum total testosterone value
Time frame: Baseline and at 1m,3m, 6m, 9m and 12m post treatment.
Total testosterone levels are measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 175-781 ng/dL.Initial efficacy is evaluated based on the values of serum LH and serum totaltestosterone. If a subject's serum LH value below 1.5 IU/L and serum total testosterone value below 100 ng/dL at 3m post treatment, it is defined as failure to pulsatile GnRH treatment and continuous treatment is stopped. Otherwise, pulsatile GnRH treatment is continued.
3 secondary outcomes
Change of testicular volume
Time frame: Baseline and at 1m,3m, 6m, 9m and 12m post treatment
Change of sperm counts by routine semen analysis
Time frame: Baseline and at 3m, 6m, 9m and 12m post treatment
the rate of impregnating subject's wife
Time frame: at 3m, 6m, 9m and 12m post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Results publication: PubMed 25131486Shao WM, Bai WJ, Chen YM, Liu L, Wang YJ. [Micropump infusion of gonadorelin in the treatment of hypogonadotropic hypogonadism in patients with pituitary stalk interruption syndrome: cases analysis and literature review]. Beijing Da Xue Xue Bao Yi Xue Ban. 2014 Aug 18;46(4):642-5. Chinese.
- Derived from this study: PubMed 28368486Zheng J, Mao J, Xu H, Wang X, Huang B, Liu Z, Cui M, Xiong S, Ma W, Min L, Kaiser UB, Nie M, Wu X. Pulsatile GnRH Therapy May Restore Hypothalamus-Pituitary-Testis Axis Function in Patients With Congenital Combined Pituitary Hormone Deficiency: A Prospective, Self-Controlled Trial. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2291-2300. doi: 10.1210/jc.2016-3990.
- Individual participant dataSharing planned: No
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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.
Xue-yan Wu contact
Xue-yan Wu principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gonadotropin-releasing Hormone in people with Hypogonadotropic Hypogonadism, run by Peking Union Medical College Hospital 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 2 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 10 Mar 2016. 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.
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?
Contact Xue-yan Wu (wuxueyan@pumch.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of serum Luteinizing Hormone(LH) value (time frame: Baseline and at 1m,3m, 6m, 9m and 12m post treatment.). The study lists 3 primary outcomes in all. 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 NCT02705014, which also lists 2 linked publications.
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 10 Mar 2016.