What side effects are associated with this type of intervention?

Common treatments for Hypogonadotropic Hypogonadism that stimulate the release of gonadotropin-releasing hormone (GnRH), such as Kisspeptin and GnRH analogs, can have several side effects. These may include headaches, nausea, hot flashes, and mood swings. In some cases, patients may experience injection site reactions, and long-term use can lead to decreased bone density. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

FDA-approved treatments for Hypogonadotropic Hypogonadism often involve the use of GnRH analogs, which stimulate the release of gonadotropins. Examples include synthetic GnRH agonists like leuprolide and GnRH antagonists such as degarelix. These treatments help in inducing ovulation and managing reproductive functions. Kisspeptin, which is being studied for its role in stimulating GnRH release, represents a potential future therapeutic option, although it is not yet FDA-approved.

What other types of research exist?

Promising novel alternatives to Kisspeptin for Hypogonadotropic Hypogonadism patients include d-Trp6-luteinizing hormone-releasing hormone, which has shown effectiveness in inducing ovulation and pregnancy in anovulatory women, and TAK-013, a novel nonpeptide and orally active GnRH antagonist that has demonstrated suppression of LH release in preclinical studies. These treatments offer potential clinical applications for stimulating GnRH release.

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Hormone Therapy

Kisspeptin for Reproductive Disorders

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

Healthy men between 21 and 40 years old with normal erectile and ejaculatory function, and testicular volume >15 ml

Men and women with hypogonadotropic hypogonadism

Must not have

Subjects with reproductive disorders with history of a medication reaction requiring emergency medical care, and those with pituitary adenoma or a macroprolactinoma confirmed on MRI imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand how kisspeptin, a hormone that triggers the release of another hormone, affects people with certain reproductive disorders. Participants with specific reproductive health issues will receive kisspeptin to see if their bodies can respond correctly. The goal is to learn more about reproductive health and improve future diagnostics.

Who is the study for?

This trial is for healthy men (21-40) with normal sexual function, women (21-40) with regular menstrual cycles, postmenopausal women (50-60), and individuals diagnosed with reproductive disorders like PCOS or hypogonadotropic hypogonadism. Participants should not have chronic diseases, a history of severe medication reactions, or excessive substance use.

What is being tested?

The study investigates the effects of kisspeptin on the reproductive system by administering it to participants. Kisspeptin is known to trigger hormone release including GnRH which plays a key role in reproduction.

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, acne, weight change, or injection site discomfort.

Eligibility Criteria

Inclusion Criteria

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

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I am a healthy man, 21-40, with normal sexual and testicular function.

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I have been diagnosed with hypogonadotropic hypogonadism.

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I am a healthy woman who has gone through menopause.

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I do not use illegal drugs and drink less than 10 alcoholic drinks a week.

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I have normal sexual function and no reproductive health issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a reproductive disorder and have had a severe medication reaction or a confirmed pituitary tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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.

Trial Design

1Treatment groups

Experimental Treatment

Group I: kisspeptin, GnRHExperimental Treatment2 Interventions

Intravenous (IV) or subcutaneous (SC) administration of kisspeptin 112-121 and/or administration of GnRH

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

kisspeptin 112-121

2013

Completed Phase 1

~420

GnRH

2017

Completed Phase 2

~640

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Hypogonadotropic Hypogonadism (HH) include the administration of gonadotropin-releasing hormone (GnRH) and its analogs, as well as kisspeptin. GnRH therapy works by stimulating the pituitary gland to release luteinizing hormone (LH) and follicle-stimulating hormone (FSH), which are crucial for gonadal function and sexual development. Kisspeptin, a naturally occurring hormone, also stimulates the release of GnRH, thereby promoting the secretion of LH and FSH. These treatments are vital for HH patients as they help restore normal reproductive function and hormonal balance, addressing symptoms such as delayed puberty and infertility.

[Pulsatile administration of GnRH: from the future to the present].Diurnal modulation of rat hypothalamic gonadotropin-releasing hormone release by melatonin in vitro.Kisspeptin modulates sexual and emotional brain processing in humans.