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Gonadotropin Releasing Hormone Agonist

Hormone Stimulation for Hypogonadotropic Hypogonadism

Phase 1

Recruiting

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

For healthy subjects: Normal reproductive function and history

Negative urine drug screen panel

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 minutes of administration

Awards & highlights

Study Summary

This trial is testing if a drug that blocks dynorphin will help people with reproductive disorders by stimulating the production of 2 other hormones.

Who is the study for?

This trial is for healthy men and women aged 21-40 with normal reproductive function, or those aged 18-75 with hypogonadotropic hypogonadism (HH), having stable medical conditions. Participants must have certain blood levels within specific ranges, a BMI of 18.5-30kg/m2 for healthy subjects, and not be seeking fertility, pregnant or breastfeeding.Check my eligibility

What is being tested?

The study tests the effects of naloxone on stimulating hormones important for reproduction—GnRH and kisspeptin—in both healthy individuals and those with HH. The hypothesis suggests that naloxone can increase these hormone levels by blocking dynorphin.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to hormonal changes such as mood swings, weight change, altered libido or menstrual cycle in women. Naloxone could also cause withdrawal-like symptoms if endogenous opioids are blocked.

Eligibility Criteria

Inclusion Criteria

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

Select...

My reproductive health and history are normal.

Select...

My drug test results were negative.

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

Luteinizing hormone

Side effects data

From 2008 Phase 3 trial • 19 Patients • NCT00710385

18%

Mild Opioid Withdrawal

12%

urticaria

vomiting

dizziness

chest discomfort

100%

80%

60%

40%

20%

Study treatment Arm

Combined for All Study Conditions

Trial Design

1Treatment groups

Experimental Treatment

Group I: Naloxone, Kisspeptin, GnRHExperimental Treatment3 Interventions

Intravenous (IV) administration of kisspeptin 112-121, GnRH, and naloxone

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Kisspeptin 112-121

2017

Completed Phase 2

~40

Naloxone

2014

Completed Phase 3

~1240

GnRH

2017

Completed Phase 2

~320

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,353 Total Patients Enrolled

Stephanie B Seminara, MDPrincipal InvestigatorMassachusetts General Hospital

8 Previous Clinical Trials

5,478 Total Patients Enrolled

Media Library

Gonadotropin Releasing Hormone (GnRH) (Gonadotropin Releasing Hormone Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT01952782 — Phase 1

Hypogonadotropic Hypogonadism Research Study Groups: Naloxone, Kisspeptin, GnRH

Hypogonadotropic Hypogonadism Clinical Trial 2023: Gonadotropin Releasing Hormone (GnRH) Highlights & Side Effects. Trial Name: NCT01952782 — Phase 1

Gonadotropin Releasing Hormone (GnRH) (Gonadotropin Releasing Hormone Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01952782 — Phase 1

Frequently Asked Questions

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

What therapeutic benefits does Naloxone have?

"Naloxone is chiefly utilized to reduce the effects of opioids, though it also has therapeutic benefits for pain, pruritus and septic shock."

Answered by AI

How many participants have enrolled in this experiment?

"Affirmative. Clinicaltrials.gov data indicates that this research trial is presently seeking participants, with the first posting of the study done on January 1st 2014 and latest update made June 29th 2022. A total of 128 patients need to be enrolled from a single site."

Answered by AI

Are there still openings for this research study?

"Affirmative. According to clinicaltrials.gov, recruitment for the trial commenced on January 1st 2014 and was most recently updated on June 29th 2022. The research is still in search of 128 participants at a single medical site."

Answered by AI

Has Naloxone been evaluated in experimental studies previously?

"At present, there are 80 studies in progress that explore Naloxone's potential. Of these investigations, 19 have advanced to Phase 3 testing and most of them originate from White River Junction, Vermont. Altogether 1436 locations across the world are conducting research into this treatment."

Answered by AI

Is this investigation open to people under the age of sixty?

"Patients between the ages of 18 and 75 are welcome to participate in this clinical trial."

Answered by AI

Has the Federal Drug Administration sanctioned Naloxone for clinical use?

"As this is only a Phase 1 trial, with minimal evidence to support safety and efficacy, the team at Power assigns Naloxone a score of 1 on its scale."

Answered by AI

What eligibility requirements must be met to participate in this clinical experiment?

"To be eligible for this medical trial, participants must show signs of hypogonadism and fall between the ages of 18 to 75. A total of 128 candidates are being admitted into the study."

Answered by AI