kisspeptin, GnRH, naloxone for Idiopathic Hypogonadotropic Hypogonadism

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Idiopathic Hypogonadotropic Hypogonadismkisspeptin, GnRH, naloxone - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Idiopathic Hypogonadotropic Hypogonadism

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 35 hours

35 hours
Pulse Rate
Average change in Luteinizing Hormone (LH) pulse frequency

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

kisspeptin, GnRH, naloxone
1 of 1

Experimental Treatment

23 Total Participants · 1 Treatment Group

Primary Treatment: kisspeptin, GnRH, naloxone · No Placebo Group · Phase 2

kisspeptin, GnRH, naloxoneExperimental Group · 3 Interventions: Naloxone, kisspeptin, GnRH, naloxone, GnRH · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naloxone
FDA approved
Gonadorelin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 35 hours

Who is running the clinical trial?

Stephanie B. Seminara, MDLead Sponsor
5 Previous Clinical Trials
535 Total Patients Enrolled
2 Trials studying Idiopathic Hypogonadotropic Hypogonadism
74 Patients Enrolled for Idiopathic Hypogonadotropic Hypogonadism
Stephanie Seminara, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
60 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have low or low-normal levels of gonadotropins.
The patient has no abnormal pituitary or hypothalamic findings on Magnetic Resonance Imaging (MRI).
You have a thyroid stimulating hormone (TSH) and prolactin level within the reference range.
You have been diagnosed with HH.
You have no history of a medication reaction requiring emergency medical care.