Hormone Therapy

GnRH for Kallmann Syndrome

Massachusetts General Hospital, Boston, MA

Targeting 4 different conditionsGnRH +1 morePhase 1RecruitingLed by Stephanie B Seminara, MDResearch Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tanner stage I OR II breast development with no change in the past 6 months

bone age less than chronological age

Must not have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upwithin 30 minutes of administration

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Study Summary

This trial is testing whether kisspeptin can help diagnose which children with delayed puberty will eventually enter puberty on their own, and which children have a permanent condition.

Eligible Conditions

Kallmann Syndrome
Gonadotropin-Releasing Hormone Deficiency
Delayed Puberty
Hypogonadotropic Hypogonadism

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You have not experienced any breast development changes in the past 6 months and are in the early stages of puberty.

Select...

Your bones are not as developed as they should be for your age.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 minutes of administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 minutes of administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 minutes of administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average change in luteinizing hormone (LH) in response to kisspeptin

Side effects data

From 2009 Phase 2 trial • 36 Patients • NCT00586898

22%

Hyperglycemia

19%

Hot Flashes

17%

Dyspnea

14%

Hyperkalemia

SGPT (ALT)

Hypoglycemia

Pneumonitis

Cardiovascular, other

100%

80%

60%

40%

20%

Study treatment Arm

All Participants

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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

Gonadorelin

FDA approved

kisspeptin 112-121

2011

Completed Phase 1

~100

0 / 5Eligibility criteria met

Find a site

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,814 Previous Clinical Trials

13,565,252 Total Patients Enrolled

8 Trials studying Kallmann Syndrome

5,873 Patients Enrolled for Kallmann Syndrome

Stephanie B Seminara, MDPrincipal Investigator

Massachusetts General Hospital

8 Previous Clinical Trials

5,582 Total Patients Enrolled

3 Trials studying Kallmann Syndrome

5,162 Patients Enrolled for Kallmann Syndrome

Media Library

GnRH (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01438034 — Phase 1

Kallmann Syndrome Research Study Groups: Kisspeptin, GnRH

Kallmann Syndrome 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

Frequently Asked Questions

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

What is the uppermost participation limit for this experiment?

"Affirmative, the clinical trial website presents information that this research is presently recruiting participants. This study was first advertised on November 1st 2011 and has been modified recently on June 29th 2022. The investigators have scheduled to accept 60 test subjects from a single medical facility."

Answered by AI

Can I be considered as a participant in this experiment?

"Sixty participants aged between 12 and 17 who are experiencing a delay in puberty will be accepted into this medical trial. To qualify, adolescent girls must have Tanner stage I or II breast development with no changes for the past 6 months; boys should weigh more than 28kg and present a bone age less than their chronological age."

Answered by AI

Has research been conducted with the hormone GnRH before?

"Presently, 46 trials exploring GnRH are underway. 10 of these being in the later stages (Phase 3). Although most research on this hormone is based out of Chicago Illinois, 1321 other locations host studies for this therapy."

Answered by AI

Are there any potential hazards associated with GnRH administration?

"Our team has assigned GnRH a score of 1 due to lack of evidence for the drug's efficacy and safety, as it is only in its first stage of clinical trials."

Answered by AI

Is the recruiting process for this research experiment currently underway?

"Yes, there is evidence on clinicaltrials.gov that this medical trial is actively recruiting participants. Initially posted in November 2011 and last edited June 2022, the study seeks to enrol 60 patients at a single location."

Answered by AI