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Gonadotropin-releasing Hormone Agonist

Opioid Antagonist Therapy for Low Testosterone

Phase 2
Waitlist Available
Led By Stephanie Seminara, MD
Research Sponsored by Stephanie B. Seminara, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If applicable, able to undergo appropriate washout from hormone therapy
No prescription medications known to affect reproductive endocrine function for at least 2 months or for 5 half-lives of the drug (whichever is shorter) except for medications used to treat the subject's reproductive condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and during treatment
Awards & highlights

Study Summary

This trial will test if opioid antagonists can help with idiopathic hypogonadotropic hypogonadism by looking at the subject's hypothalamic-pituitary-gonadal axis.

Who is the study for?
This trial is for adults with low testosterone or estradiol due to hypogonadotropic hypogonadism (HH), who are not currently seeking fertility, and have stable medical conditions. Participants should not be on medications affecting reproductive functions, have no history of severe medication reactions, and must pass certain blood tests.Check my eligibility
What is being tested?
The study is testing the impact of opioid antagonists like naloxone on the hormonal axis in people with idiopathic HH. It aims to understand how blocking opioids affects hormones that control reproductive functions using substances such as kisspeptin and GnRH.See study design
What are the potential side effects?
Potential side effects may include reactions at injection sites, changes in mood or energy levels, gastrointestinal discomfort, headaches, and possible alterations in hormone levels which could affect various bodily functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can stop my hormone therapy for a certain period if needed.
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I haven't taken drugs affecting my hormones except for treating my reproductive condition.
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My other health conditions are stable and under control.
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I am not pregnant or breastfeeding.
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My hemoglobin levels are within the normal range for my gender.
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I have been diagnosed with hypogonadotropic hypogonadism and have low testosterone or estradiol levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and during treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and during treatment 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) pulse frequency
Secondary outcome measures
Pulse Rate

Trial Design

1Treatment groups
Experimental Treatment
Group I: kisspeptin, GnRH, naloxoneExperimental Treatment3 Interventions
IV administration of kisspeptin 112-121; six boluses in up to a 26-hour period. IV administration of GnRH; two boluses in up to a 26-hour period. IV administration of naloxone; one bolus and an infusion over an up to 13-hour period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GnRH
2017
Completed Phase 2
~320
Naloxone
2014
Completed Phase 3
~1240

Find a Location

Who is running the clinical trial?

Stephanie B. Seminara, MDLead Sponsor
9 Previous Clinical Trials
1,317 Total Patients Enrolled
Stephanie Seminara, MDPrincipal InvestigatorMassachusetts General Hospital
5 Previous Clinical Trials
745 Total Patients Enrolled

Media Library

Kisspeptin, GnRH (Gonadotropin-releasing Hormone Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04975334 — Phase 2
Hypogonadotropic Hypogonadism Research Study Groups: kisspeptin, GnRH, naloxone
Hypogonadotropic Hypogonadism Clinical Trial 2023: Kisspeptin, GnRH Highlights & Side Effects. Trial Name: NCT04975334 — Phase 2
Kisspeptin, GnRH (Gonadotropin-releasing Hormone Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04975334 — Phase 2

Frequently Asked Questions

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

Is there any risk associated with the combination of kisspeptin, GnRH, and naloxone?

"Our team has determined that kisspeptin, GnRH and naloxone are moderately safe based on our Phase 2 trial data. While efficacy is yet unproven, safety protocols have been tested multiple times with success."

Answered by AI

Are there still opportunities for participants to join this clinical experiment?

"Affirmative. According to the records hosted on clinicaltrials.gov, this research is currently recruiting subjects; it was initiated on December 31st 2022 and modified lastly on June 29th of that same year. This study requires 23 volunteers who can be sourced from a single medical centre."

Answered by AI

Could I be eligible to partake in this trial?

"The clinical trial is offering enrollment to 23 individuals affected by hypogonadism, aged 18-75. Applicants must meet certain criteria such as normal or low levels of gonadotropins, no abnormalities on MRI scans of the pituitary and hypothalamus glands, TSH and prolactin within a specific range, documented cases of HH with reduced testosterone/estradiol production, stable health conditions not requiring medication for at least 2 months (or 5 half lives), no medical history necessitating emergency care due to drug reaction nor opiate usage nor excessive alcohol consumption (<10 drinks weekly)."

Answered by AI

Does this trial admit participants older than twenty years of age?

"This clinical trial is designed for participants aged between 18 and 75, while there exist 12 studies catering to individuals below the legal age of consent and 70 others tailored towards elderly patients."

Answered by AI

What is the total cohort size for this research endeavor?

"Affirmative. The clinical trial database verifies that this study, which was initially listed on December 31st 2022, is actively recruiting patients. A total of 23 individuals must be recruited from 1 medical site."

Answered by AI

What prior research has been conducted on the interplay between kisspeptin, GnRH and naloxone?

"At present, 19 trials for kisspeptin, GnRH and naloxone are in Phase 3 with a further 80 active studies. White River Junction, Vermont is one of 1,436 sites that are hosting investigations into this subject matter."

Answered by AI

In what medical contexts are kisspeptin, GnRH and naloxone typically prescribed?

"The medications kisspeptin, GnRH and naloxone are proven effective for treating opioids. Beyond this use-case, they have also been applied to address pain, pruritus, and septic shock."

Answered by AI
~15 spots leftby May 2025