Kisspeptin for Reproductive Disorders

Recruiting in Palo Alto (17 mi)

Overseen ByStephanie B. Seminara, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

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

I have been diagnosed with hypogonadotropic hypogonadism.

I am a healthy woman who has gone through menopause.

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

I have normal sexual function and no reproductive health issues.

Exclusion Criteria

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

Participant Groups

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.

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

GnRH is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Gonadorelin for: