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Hormone Therapy

gonadotropin releasing hormone (GnRH) for Kallmann Syndrome

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is examining how well Kallmann syndrome (KS) and idiopathic hypogonadotropic hypogonadism (IHH) respond to a treatment that replaces the hormone which is absent in IHH.

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
endogenous LH secretion pattern
Secondary outcome measures
sperm count
testicular volume

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GnRH TreatmentExperimental Treatment1 Intervention
Subjects receive long term pulsatile GnRH therapy
Group II: off treatmentActive Control1 Intervention
Subjects undergo the baseline evaluation off treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
gonadotropin releasing hormone (GnRH)
1989
Completed Phase 1
~630

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,197,731 Total Patients Enrolled
8 Trials studying Kallmann Syndrome
5,273 Patients Enrolled for Kallmann Syndrome
Stephanie B Seminara, MDPrincipal InvestigatorMassachusetts General Hospital
8 Previous Clinical Trials
4,982 Total Patients Enrolled
3 Trials studying Kallmann Syndrome
4,562 Patients Enrolled for Kallmann Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
ScienceJournal
Hypophysial Responses to Continuous and Intermittent Delivery of Hypothalamic Gonadotropin-releasing Hormone
Belchetz, P. E., T. M. Plant, Y. Nakai, E. J. Keogh, and E. Knobil. 1978. “Hypophysial Responses to Continuous and Intermittent Delivery of Hypothalamic Gonadotropin-releasing Hormone”. Science. American Association for the Advancement of Science (AAAS). doi:10.1126/science.100883.
Endocrine ReviewsJournal
Gonadotropin-releasing Hormone Deficiency in the Human (idiopathic Hypogonadotropic Hypogonadism and Kallmann’s Syndrome): Pathophysiological and Genetic Considerations
Seminara, Stephanie B., Frances J. Hayes, and William F. Crowley Jr. 1998. “Gonadotropin-releasing Hormone Deficiency in the Human (idiopathic Hypogonadotropic Hypogonadism and Kallmann’s Syndrome): Pathophysiological and Genetic Considerations”. Endocrine Reviews. The Endocrine Society. doi:10.1210/edrv.19.5.0344.
New England Journal of MedicineJournal
Adult-onset Idiopathic Hypogonadotropic Hypogonadism — A Treatable Form of Male Infertility
Nachtigall, Lisa B., Paul A. Boepple, François P. Pralong, and William F. Crowley Jr.. 1997. “Adult-onset Idiopathic Hypogonadotropic Hypogonadism — A Treatable Form of Male Infertility”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm199702063360604.
The Journal of Clinical Endocrinology & MetabolismJournal
Insight into the Ontogeny of Gnrh Neurons from Patients Born Without a Nose
Delaney, Angela, Rita Volochayev, Brooke Meader, Janice Lee, Konstantinia Almpani, Germaine Y Noukelak, Jennifer Henkind, et al.. 2020. “Insight into the Ontogeny of Gnrh Neurons from Patients Born Without a Nose”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/clinem/dgaa065.
~17 spots leftby Apr 2025
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