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Hormone Therapy

Kisspeptin in the Evaluation of Delayed Puberty

Phase 1
Waitlist Available
Led By Stephanie B Seminara, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if certain hormones can predict whether delayed puberty in children will resolve on its own or need treatment. It involves children with delayed puberty. The hormones signal the body to start puberty, helping doctors determine if the delay is temporary or permanent.

Eligible Conditions
  • Delayed Puberty
  • Hypogonadotropic hypogonadism
  • Kallmann Syndrome
  • Gonadotropin-Releasing Hormone Deficiency
  • Hypogonadotropic Hypogonadism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2009 Phase 2 trial • 36 Patients • NCT00586898
22%
Hyperglycemia
19%
Hot Flashes
17%
Dyspnea
14%
Hyperkalemia
8%
SGPT (ALT)
6%
Hypoglycemia
3%
Pneumonitis
3%
Cardiovascular, other
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Participants

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Kisspeptin, GnRHExperimental Treatment2 Interventions
Intravenous (IV) administration of kisspeptin 112-121 0.24 nmol/kg and GnRH 75 ng/kg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GnRH
2017
Completed Phase 2
~640
kisspeptin 112-121
2013
Completed Phase 1
~420

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,775 Total Patients Enrolled
Stephanie B Seminara, MDPrincipal InvestigatorMassachusetts General Hospital
8 Previous Clinical Trials
5,149 Total Patients Enrolled

Media Library

GnRH (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01438034 — Phase 1
Delayed Puberty Research Study Groups: Kisspeptin, GnRH
Delayed Puberty Clinical Trial 2023: GnRH Highlights & Side Effects. Trial Name: NCT01438034 — Phase 1
GnRH (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01438034 — Phase 1
~2 spots leftby Dec 2025
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