HypogonadismNCT02356172
Psychological Outcomes in Isolated GnRH Deficiency
An observational study of Hypogonadism, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Background: Isolated (or Congenital) GnRH Deficiency (IGD) is a rare disease. People who have this go through puberty late. Some never reach puberty or don t complete it without treatment. They also may have an impaired sense of smell or other health problems. Read more about this study
- Who is it for?
- Ages 18 to 200 years
- Conditions the study is for
- Hypogonadism
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2015to 16 Jul 2019
- Phase
- Observational
- 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 200 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females with clinical findings consistent with IGD who are greater than or equal to 18 years old and treated with hormone replacement therapy for IGD at the full adult replacement dose for at least 3 months. Clinical findings of IGD will be confirmed by a nurse or physician associated with this protocol, and include: clinical presentation consistent with a diagnosis of IGD, such as delayed, incomplete, or absent pubertal development, and a record of serum hormone levels demonstrating low total testosterone (males) or estradiol (females) in association with low or inappropriately normal gonadotropin levels in a clinic note or history and physical, and individuals with records demonstrating failure to undergo normal puberty. Anosmia may or may not be present. Since IGD presents as a phenotypic spectrum, there are no specific exclusion criteria for this study, except as noted below.
- Healthy males or females who are greater than or equal to 18 years old.
Who cannot join
- Patients with a diagnosis of IGD who are <18 years old;
- Patients with a diagnosis of IGD who are not on a full adult replacement dose of sex hormone therapy for at least 3 months;
- Patients who do not have a diagnosis of IGD as indicated by the inclusion criteria above;
- Patients without access to a computer connected to the internet;
- Patients who cannot read, write, and understand English at an eighth grade level or above.
- ELIGIBILITY CRITERIA FOR HEALTHY CONTROLS:
Show all 12Show fewer
- Subjects with any chronic medical condition, other than seasonal/environmental allergies;
- Subjects with a BMI < 18.5 or > 29.9;
- Subjects with prior history of abnormal pubertal development, infertility, or anosmia;
- Subjects with a family history of IGD;
- Subjects without access to a computer connected to the internet;
- Subjects who cannot read, write, and understand English at an eighth grade level or above.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Child Health and Human Development (NICHD), 9000 Rockville
Bethesda, Maryland, 20892
About this study
Official title: Psychological Outcomes in Isolated GNRH Deficiency
Background:
- Isolated (or Congenital) GnRH Deficiency (IGD) is a rare disease. People who have this go through puberty late. Some never reach puberty or don t complete it without treatment. They also may have an impaired sense of smell or other health problems. Research shows that disorders like this can have a negative effect on a person s psychological profile.
Read more
Objective:
- To understand the psychological outcomes in people with IGD. These can include depression, anxiety, poor health, and poor social function.
Eligibility:
- Adults age 18 and over with IGD. They must be currently on a full dose of hormone replacement therapy for at least 3 months.
- Healthy adult volunteers.
Design:
- Participants will get a username and password. This will give them access to questions online. They can do this from any computer connected to the Internet.
- Participants will log in and complete the questionnaires. There are 5 total, but they will appear as 1 continuous set of questions. Answering them takes about 1 hour or less.
- The first set is about the participant s disorder. The rest ask about depression, anxiety, global health, and social function.
- All answers will be used for research and to better understand reproductive disorders. Only researchers from the NIH Unit on Genetics of Puberty and Reproduction and from this study will know which answers belong to which participant.
Read the detailed description
Isolated GnRH Deficiency (IGD) is a rare disorder characterized by decreased secretion of GnRH, resulting in impaired gonadotropin secretion and subsequent impaired sex-steroid production. Patients with this rare clinical syndrome present with absent, delayed, or stalled pubertal development by eighteen years of age. In addition, non-reproductive phenotypes of this spectrum have been identified in some individuals, including anosmia, auditory and ocular defects, and skeletal, neurological, and renal anomalies.
Due to the complex heterogeneity among affected individuals and the rarity of the disease itself, the phenotypic spectrum has not been fully investigated. The relationship between psychological disorders and IGD remains largely unexplored as a phenotypic association, despite evidence that disorders of puberty and reproduction can have a negative impact on the psychological profile.
This study aims to conduct a preliminary investigation into the association between psychological symptoms and IGD. We plan to recruit adult patients with a diagnosis of IGD to complete online assessments that measure psychological health outcomes from the patient perspective in order to gauge the prevalence of negative emotional states among affected individuals, compared to healthy controls. This will determine whether further studies are necessary to investigate psychiatric disease as part of the phenotypic spectrum of the disorder, and will improve our understanding of this complex disorder as a whole. Greater knowledge of the psychological impact of IGD may impact the current standards of evaluation and treatment of patients with delayed pubertal maturation.
- Conditions
- Hypogonadism
- Keywords
- Quality of Life, Depression, Kallmann Syndrome, Hypogonadotropic Hypogonadism
- Medical subject headings
- Hypogonadism, Depression, Kallmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Healthy males or females who are greater than or equal to 18 years old. | |
| Patients | Males or females with a diagnosis of IGD (Isolated GnRH Deficiency) who are greater than or equal to 18 years old. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is to identify whether patients with Isolated GnRH Deficiency have a higher prevalence of negative emotional states, including depression, anxiety, poor social function and quality of life, than healthy controls.
In analysis phase
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study start4 Feb 2015
- Primary completion1 Jun 2017
- Study completion16 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Angela Delaney Freedman, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356172
- Sponsor's protocol ID
- 999915077
- Other IDs
- 15-CH-N077
- Status last verified
- 16 Jul 2019
- First submitted
- 4 Feb 2015
- Last updated
- 18 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Outcomes in Isolated GNRH Deficiency
- ClinicalTrials.gov ID
- NCT02356172
- Acronym / sponsor ID
- 999915077
- Conditions
- Hypogonadism
- Keywords
- Quality of Life, Depression, Kallmann Syndrome, Hypogonadotropic Hypogonadism
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 4 Feb 2015
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 5 Feb 2015 (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.
Background:
- Isolated (or Congenital) GnRH Deficiency (IGD) is a rare disease. People who have this go through puberty late. Some never reach puberty or don t complete it without treatment. They also may have an impaired sense of smell or other health problems. Research shows that disorders like this can have a negative effect on a person s psychological profile.
Objective:
- To understand the psychological outcomes in people with IGD. These can include depression, anxiety, poor health, and poor social function.
Eligibility:
- Adults age 18 and over with IGD. They must be currently on a full dose of hormone replacement therapy for at least 3 months.
- Healthy adult volunteers.
Design:
- Participants will get a username and password. This will give them access to questions online. They can do this from any computer connected to the Internet.
- Participants will log in and complete the questionnaires. There are 5 total, but they will appear as 1 continuous set of questions. Answering them takes about 1 hour or less.
- The first set is about the participant s disorder. The rest ask about depression, anxiety, global health, and social function.
- All answers will be used for research and to better understand reproductive disorders. Only researchers from the NIH Unit on Genetics of Puberty and Reproduction and from this study will know which answers belong to which participant.
Detailed description
Isolated GnRH Deficiency (IGD) is a rare disorder characterized by decreased secretion of GnRH, resulting in impaired gonadotropin secretion and subsequent impaired sex-steroid production. Patients with this rare clinical syndrome present with absent, delayed, or stalled pubertal development by eighteen years of age. In addition, non-reproductive phenotypes of this spectrum have been identified in some individuals, including anosmia, auditory and ocular defects, and skeletal, neurological, and renal anomalies.
Due to the complex heterogeneity among affected individuals and the rarity of the disease itself, the phenotypic spectrum has not been fully investigated. The relationship between psychological disorders and IGD remains largely unexplored as a phenotypic association, despite evidence that disorders of puberty and reproduction can have a negative impact on the psychological profile.
This study aims to conduct a preliminary investigation into the association between psychological symptoms and IGD. We plan to recruit adult patients with a diagnosis of IGD to complete online assessments that measure psychological health outcomes from the patient perspective in order to gauge the prevalence of negative emotional states among affected individuals, compared to healthy controls. This will determine whether further studies are necessary to investigate psychiatric disease as part of the phenotypic spectrum of the disorder, and will improve our understanding of this complex disorder as a whole. Greater knowledge of the psychological impact of IGD may impact the current standards of evaluation and treatment of patients with delayed pubertal maturation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | –Healthy males or females who are greater than or equal to 18 years old. |
| Patients | – | –Males or females with a diagnosis of IGD (Isolated GnRH Deficiency) who are greater than or equal to 18 years old. |
Who may qualify
- Ages
- 18 to 200 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males or females with clinical findings consistent with IGD who are greater than or equal to 18 years old and treated with hormone replacement therapy for IGD at the full adult replacement dose for at least 3 months. Clinical findings of IGD will be confirmed by a nurse or physician associated with this protocol, and include: clinical presentation consistent with a diagnosis of IGD, such as delayed, incomplete, or absent pubertal development, and a record of serum hormone levels demonstrating low total testosterone (males) or estradiol (females) in association with low or inappropriately normal gonadotropin levels in a clinic note or history and physical, and individuals with records demonstrating failure to undergo normal puberty. Anosmia may or may not be present. Since IGD presents as a phenotypic spectrum, there are no specific exclusion criteria for this study, except as noted below.
- Healthy males or females who are greater than or equal to 18 years old.
Key exclusion criteria (12 listed)
- Patients with a diagnosis of IGD who are <18 years old;
- Patients with a diagnosis of IGD who are not on a full adult replacement dose of sex hormone therapy for at least 3 months;
- Patients who do not have a diagnosis of IGD as indicated by the inclusion criteria above;
- Patients without access to a computer connected to the internet;
- Patients who cannot read, write, and understand English at an eighth grade level or above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome is to identify whether patients with Isolated GnRH Deficiency have a higher prevalence of negative emotional states, including depression, anxiety, poor social function and quality of life, than healthy controls.
Time frame: At enrollment
In analysis phase
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 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.
Angela Delaney Freedman, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypogonadism, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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 2 inclusion and 12 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: stopped early, as of the sponsor's last update on 18 Jul 2019. 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 United States. 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?
The study was stopped early. 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?
The primary outcome is to identify whether patients with Isolated GnRH Deficiency have a higher prevalence of negative emotional states, including depression, anxiety, poor social function and quality of life, than healthy controls. (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2019.