CLINICAL TRIAL

GnRH for Puberty, Delayed

Recruiting · < 18 · All Sexes · Boston, MA

This study is evaluating whether a hormone may be used to determine whether a child's delayed puberty will be self-resolving or permanent.

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About the trial for Puberty, Delayed

Eligible Conditions
Idiopathic Hypogonadotropic Hypogonadism · Hypogonadism · Kallmann Syndrome · Puberty, Delayed · Gonadotrophin releasing hormone deficiency

Treatment Groups

This trial involves 2 different treatments. GnRH is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
GnRH
DRUG
kisspeptin 112-121
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gonadorelin
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Adolescent Girls
ages 12-17 years
The individual has Tanner stage I or II breast development that has not changed in the past six months. show original
Adolescent boys are going through a lot of changes show original
ages 13.5-17 years
The person has a bone age that is younger than their chronological age. show original
At least 28 kg in weight. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Within 30 minutes of administration
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Within 30 minutes of administration.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether GnRH will improve 1 primary outcome in patients with Puberty, Delayed. Measurement will happen over the course of Within 30 minutes of administration.

Average change in luteinizing hormone (LH) in response to kisspeptin
WITHIN 30 MINUTES OF ADMINISTRATION

Who is running the study

Principal Investigator
S. B. S.
Prof. Stephanie B. Seminara, MD
Massachusetts General Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes puberty, delayed?

A lack of a single explanation for puberty onset, delayed development of secondary sexual characteristics, and a wide variation among adolescents in the age of first sexual intercourse is reassuring: this should reassure parents that their adolescents' puberty is not delayed and that they are not delayed adolescents.

Anonymous Patient Answer

What is puberty, delayed?

Delayed puberty is a normal pubertal process of development which in children can delay starting puberty by as much as two or three years. As the child grows older, pubertal changes occur more slowly. About 15% of girls are delayed in their genital pubertal changes in childhood. Most of the time it is a harmless delay of about two years. There are few causes of it in young people and most normal cases are resolved by adolescence. The majority of cases are related to growth hormone deficiency, and treatment with growth hormone is effective in bringing most cases to resolution.

Anonymous Patient Answer

Can puberty, delayed be cured?

Treatment for adolescent growth problems requires careful consideration, with a focus on helping adolescents adjust to adolescence. Because many growth disorders are permanent, medical attention is crucial. Medical issues are rarely reversible, but if they are treatable at all, it can be accomplished with careful attention and long-term follow-up once the condition has been treated.

Anonymous Patient Answer

How many people get puberty, delayed a year in the United States?

The frequency of delayed puberty was high in U.S. children and adolescents. This represents an important public health problem because delayed puberty has a significant negative impact of the quality of life of children, even in childhood.

Anonymous Patient Answer

What are common treatments for puberty, delayed?

There is often a delay between diagnoses (if given) and start of treatment as to what are the common treatments; therefore, a systematic process should be followed and used to start treatment as soon as possible. The use of psychoeducational material in combination with pharmaceuticals is effective for a significant proportion of children, and can be helpful for others, if used in a comprehensive way. Pharmacological treatment with the use of antipsychic drugs is very common. If there is a fear of physical harm, there is no treatment at all that could be used. Although the number of children has been declining, in some areas the increase in untreated disease continues.

Anonymous Patient Answer

What are the signs of puberty, delayed?

The initial changes in pubertal males are a decrease in the length of the penis in about 5% of males and pubic hair in about 2% of males. The initial changes in pubertal females are vaginal bleeding in about 6% and breast enlargement, especially when other features are present such as menstrual bleeding and the development of pubic hair, in up to 6% of females. More than 2 years after the beginning of the clinical changes in pubertal boys the testes are fully developed and are now visible in an ultrasound exam, whereas in pubertal girls the testes are enlarged and apparent in an ultrasound exam in some but not all women.

Anonymous Patient Answer

What is the latest research for puberty, delayed?

If you are thinking about Delayed Puberty or delayed puberty, and you have a doctor who can help you, then [with power(https://www.withpower.com/diseases/puberty/over-the-counter-puberty-drugs-and-therapies)] you can [power(https://www.withpower.com/diseases/puberty/over-the-counter-puberty-drugs-and-therapies)] look into the latest research on puberty delay or delayed puberty.

Anonymous Patient Answer

How does gnrh work?

GnRH treatment of precocious puberty is a safe short-term treatment for hormonally-controlled advanced puberty and in the long term can result in regression, ie, cessation of puberty, of the physical, sexual and hormonal factors that influence adult fertility. A short course of GnHRH, using the usual daily low dose does not cause long-term hypergonadotropic effects, as has been proposed by some. Clinical judgement should be exercised when prescribing a GnRH analog for the first time.

Anonymous Patient Answer

What is the primary cause of puberty, delayed?

The cause of puberty is poorly understood. Childhood and pubertal onset are strongly associated with many factors, with the role of environment much less clear. Possible environmental factors include exposure to hormones during pregnancy, exposure to endocrine-disrupting compounds in the environment, growth hormone insensitivity, early onset of puberty, and genetics. [Novel treatments may be developed if we understand puberty. We are currently working diligently to develop new treatments to address the most important question regarding puberty, delayed puberty.

Anonymous Patient Answer

Is gnrh typically used in combination with any other treatments?

Although the treatment was similar, the combination of GnRH and GnRH agonist resulted in a better clinical remission for CD-women compared to GnRH injections alone. The combination of GnRH and GnRH agonist therapy was associated with normalization of serum anti-Mullerian hormone levels and improvement in ovarian function and follicular activity. GnRHa and GnRH seem well interchangeable.

Anonymous Patient Answer

What is the average age someone gets puberty, delayed?

(1) Half of all children and adolescents with delayed puberty have premature pubarche; and (2) The average age of time of menarche is 13.5 years earlier among women getting early pubarche compared to girls who do not get early pubarche.

Anonymous Patient Answer

What is gnrh?

Boys with pubertal delay have poorer HRQoL at age of 12 than those with pubarche. This suggests that early initiation of pubertal growth in girls is beneficial for HRQoL at adolescence.

Anonymous Patient Answer
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