Hypogonadotropic Hypogonadism Clinical Trial
Official title:
Kisspeptin in the Evaluation of Delayed Puberty
Verified date | October 2023 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this study is to test whether the hormone kisspeptin has the potential to prospectively diagnose adolescents with self-resolving or permanent delayed puberty. Some children with delayed puberty will eventually enter puberty on their own. However, some children with delayed puberty have a permanent condition and require medical treatment to undergo puberty. Right now, there is no reliable diagnostic tool to tell whether a child's delayed puberty will be self-resolving or permanent. The hormone kisspeptin has the potential to prospectively diagnose adolescents with self-resolving or permanent delayed puberty.
Status | Completed |
Enrollment | 24 |
Est. completion date | September 10, 2021 |
Est. primary completion date | September 8, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 17 Years |
Eligibility | Inclusion Criteria: Adolescent Boys - ages 13.5-17 years - testicular volume <4 mL OR 4-8 ml with no change in the past 6 months by Prader orchidometer - first morning (before 9AM) LH <2 mIU/mL and testosterone <50 ng/dL Adolescent Girls - ages 12-17 years - Tanner stage I OR II breast development with no change in the past 6 months - first morning (before 9AM) LH <2 mIU/mL and estradiol <20 pg/ml All Subjects: - bone age less than chronological age - weight = 28 kg - body mass index >10th percentile and <+3 SDS for bone age - blood pressure >5th percentile and <95th percentile for bone age and height - white blood cell counts, platelet counts, electrolytes, thyroid stimulating hormone (TSH), free thyroxine (T4) within reference range for age - erythrocyte sedimentation rate <2X the upper limit of the reference range for age - hemoglobin within reference range for girls of the same chronological age - blood urea nitrogen (BUN), creatinine, prolactin not elevated - aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no more than 2X the upper limit of the reference range - Insulin-like growth factor 1 (IGF-1) within reference range for bone age Exclusion Criteria: All Subjects: - history or presence of underlying condition that could cause delayed puberty (chronic illness, weight loss, abnormal cranial magnetic resonance imaging (MRI)) - history of an allergic drug reaction |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average change in luteinizing hormone (LH) in response to kisspeptin | Within 30 minutes of administration |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01438073 -
Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling
|
Phase 1 | |
Completed |
NCT01403532 -
Sequential Therapy for Hypogonadotropic Hypogonadism
|
Phase 4 | |
Recruiting |
NCT00456274 -
Baselines in Reproductive Disorders
|
N/A | |
Terminated |
NCT05205837 -
A Randomized, Double-blinded, Clinical, Placebo-controlled Trial on the Effects of Therapy With Letrozole and hUman Choriongonadotropin in Male Hypogonadism Induced by Illicit Use of Anabolic Androgenic Steroids- The LUCAS Trial
|
Phase 4 | |
Completed |
NCT02908074 -
A 6 Month Safety Extension Study of MBGS205
|
Phase 2 | |
Completed |
NCT05752591 -
Hypothalamic-pituitary Dysfunction in Diabetes
|
||
Terminated |
NCT03118479 -
Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism (IHH)
|
Phase 1 | |
Completed |
NCT02730169 -
Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
|
Phase 2 | |
Completed |
NCT02110368 -
Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions
|
Phase 3 | |
Recruiting |
NCT01601171 -
Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and/or Palate
|
||
Completed |
NCT01623570 -
Clinical Outcomes in WHO Type I Anovulatory Women Using r-hFSH+r-hLH in a 2:1 Ratio or hMG-HP
|
N/A | |
Terminated |
NCT00328926 -
Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])
|
Phase 4 | |
Completed |
NCT04456296 -
A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
|
Phase 4 | |
Recruiting |
NCT00914823 -
Kisspeptin Administration in the Adult
|
Phase 1 | |
Terminated |
NCT01155518 -
Hypogonadism in Young Men With Type 2 Diabetes
|
Phase 2 | |
Completed |
NCT00697814 -
Clomiphene in Males With Prolactinomas and Persistent Hypogonadism
|
Phase 2 | |
Active, not recruiting |
NCT00351416 -
Letrozole Treatment in Normal and GnRH Deficient Women
|
Phase 2/Phase 3 | |
Recruiting |
NCT05971836 -
The Molecular Basis of Inherited Reproductive Disorders
|
||
Recruiting |
NCT02705014 -
Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome
|
N/A | |
Recruiting |
NCT04648969 -
Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism
|
Phase 2 |