Psychological Outcomes in Isolated GnRH Deficiency
United States48 participantsStarted 2015-02-04
Plain-language 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. 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.
Who can participate
Age range
18 Years – 200 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* ELIGIBILITY CRITERIA FOR IGD PATIENTS:
INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
* 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:
INCLUSION CRITERIA:
Healthy ma…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: At enrollment
Trial details
NCT IDNCT02356172
SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)