Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02356172
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact
Status Terminated
Phase
Start date February 4, 2015
Completion date July 16, 2019

See also
  Status Clinical Trial Phase
Completed NCT03126656 - Effects of Testosterone on Myocardial Repolarization Phase 4
Withdrawn NCT02137265 - Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism N/A
Terminated NCT02419105 - Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors Phase 3
Completed NCT02233751 - Pharmacokinetic Study of Subcutaneous Testosterone Enanthate Phase 1
Completed NCT02222558 - Oral Testosterone for the Treatment of Hypogonadism in Males Phase 2
Completed NCT01887418 - Pharmacokinetic Study of Testosterone Enanthate Phase 1/Phase 2
Terminated NCT01092858 - NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH) Phase 4
Completed NCT00624624 - Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism N/A
Completed NCT00752869 - Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement Phase 4
Completed NCT00613288 - Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism N/A
Completed NCT00119483 - Older Men and Testosterone N/A
Completed NCT00838838 - Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis N/A
Completed NCT00004438 - Leuprolide in Treating Adults With Hypogonadotropism N/A
Withdrawn NCT00398034 - Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study. Phase 2
Completed NCT02937740 - Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natestoâ„¢ Phase 4
Completed NCT02921386 - The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate Phase 2
Completed NCT01717768 - Oral Testosterone for the Treatment of Hypogonadism Phase 2
Terminated NCT01460654 - Testosterone and Alendronate in Hypogonadal Men Phase 2
Completed NCT00998933 - Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure Phase 1
Completed NCT00663793 - ORAL T-6: Oral Androgens in Man-6 Phase 1