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Hormone Therapy

Kisspeptin for Reproductive Disorders

Phase 1
Recruiting
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
Men and women with hyperprolactinemia with confirmed diagnosis of elevated levels of prolactin measured via blood test, and willing to complete a dopamine agonist washout
Healthy women between 21 and 40 years old, not breastfeeding or pregnant, with specific menstrual cycle criteria, no evidence for androgen excess, and negative screening for Factor V Leiden if applicable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 minutes of administration
Awards & highlights

Study Summary

This trial is looking at whether a hormone called kisspeptin can help researchers understand reproductive disorders.

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.Check my eligibility
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.See study design
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 have high prolactin levels and agree to stop my current dopamine agonist treatment.
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I am a healthy woman, aged 21-40, not pregnant or breastfeeding, with regular menstrual cycles, no signs of high male hormones, and no Factor V Leiden mutation if tested.
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I am over 18, have a reproductive disorder, and haven't taken meds affecting it except for treatment.
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I am a healthy woman aged 50-60, postmenopausal, and tested negative for Factor V Leiden if needed.
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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 have been diagnosed with low hormone levels affecting my reproductive system.
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I do not use illegal drugs and drink less than 10 alcoholic drinks a week.
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I am healthy, with normal puberty development, no chronic diseases, and haven't taken prescription meds recently.
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I have normal sexual function and no reproductive health issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 minutes of administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 minutes of administration 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) in response to kisspeptin

Side effects data

From 2009 Phase 2 trial • 36 Patients • NCT00586898
22%
Hyperglycemia
19%
Hot Flashes
17%
Dyspnea
14%
Hyperkalemia
8%
SGPT (ALT)
6%
Hypoglycemia
3%
Pneumonitis
3%
Cardiovascular, other
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Participants

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
~120
GnRH
2017
Completed Phase 2
~320

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,924 Previous Clinical Trials
13,192,927 Total Patients Enrolled
Stephanie B Seminara, MDPrincipal InvestigatorMassachusetts General Hospital
8 Previous Clinical Trials
5,110 Total Patients Enrolled
Stephanie B. Seminara, MD3.73 ReviewsPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
5Patient Review
This doctor is very caring and thinks critically about symptoms. They help uplift patients' spirits and have amazing bedside manner!

Media Library

GnRH (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00914823 — Phase 1
Hypogonadotropic Hypogonadism Research Study Groups: kisspeptin, GnRH
Hypogonadotropic Hypogonadism Clinical Trial 2023: GnRH Highlights & Side Effects. Trial Name: NCT00914823 — Phase 1
GnRH (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00914823 — Phase 1

Frequently Asked Questions

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

Has the Food and Drug Administration accepted GnRH for use in medicine?

"The lack of data confirming GnRH's safety and efficacy results in a score of 1 on our team at Power's scale. This is indicative that this is an early-phase trial."

Answered by AI

What is the cap on enrollment in this clinical trial?

"Affirmative. Clinicaltrials.gov has information that attests to this medical trial being in the process of patient recruitment, which commenced on March 1st 2009 and was most recently updated on June 29th 2022. The study seeks 496 volunteers from a single site."

Answered by AI

Are there any available slots still unoccupied in this experiment?

"Indeed, according to clinicaltrials.gov this research endeavor is actively recruiting participants and was initially posted on March 1st 2009. The trial most recently updated its information on June 29th 2022 and requires 496 patients from one location to enroll in the study."

Answered by AI

What former experiments have utilized GnRH in the past?

"As of today, 46 separate clinical trials researching GnRH are ongoing with 10 in Phase 3. Of the 1321 locations conducting studies on the subject, several can be found within Chicago, Illinois."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
Maine
How old are they?
18 - 65
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

Do you need to have no pulsatile gnrh or any other hormonal response in the brain?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I believe I would make an ideal candidate for this trial. According to the inclusion criteria, I make an excellent candidate. Please consider me for this trial, thank you.
PatientReceived no prior treatments
I have PCOS and have been overwhelmed by the little research that is being done to combat this condition. I wanted to be part of the body or research so that more affected people so that they aren't found seeking for answers.
PatientReceived 1 prior treatment
~41 spots leftby Aug 2025