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Hormone Therapy

Kisspeptin 112-121 for Hyperprolactinemia

Phase 2
Waitlist Available
Led By Stephanie 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 23 days
Awards & highlights

Study Summary

This trial is looking at using a hormone to treat patients with too much prolactin in their blood, who can't take current treatments. The FDA is funding the trial.

Eligible Conditions
  • Hyperprolactinemia
  • Low Testosterone

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 23 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 23 days 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 number of luteinizing hormone (LH) pulse frequency (Kisspeptin Bolus and Baseline Sampling arm)
Change in follicle size in mm by ultrasound (Pulsatile Kisspeptin arm)
Secondary outcome measures
Average change in LH pulse amplitude (Kisspeptin Bolus and Baseline Sampling arm)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pulsatile KisspeptinExperimental Treatment1 Intervention
Subcutaneous (SC) administration of kisspeptin 112-121 0.24 nmol/kg IV every 90 minutes over eight days using a portable pump. One-time bolus of kisspeptin 112-121 2.4 nmol/kg IV (if necessary).
Group II: Kisspeptin Bolus and Baseline SamplingExperimental Treatment2 Interventions
Blood sampling every 10 minutes over two 12-hour periods. One 12-hour period without any intervention. One 12-hour period consisting of administration of 10 boluses of kisspeptin 112-121 0.24 nmol/kg intravenously (IV) in a 10-hour period and one bolus of gonadotropin-releasing hormone (GnRH) at hour 11.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Kisspeptin 112-121
2017
Completed Phase 2
~40
GnRH
2017
Completed Phase 2
~320

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,927 Previous Clinical Trials
13,198,145 Total Patients Enrolled
1 Trials studying Hyperprolactinemia
496 Patients Enrolled for Hyperprolactinemia
Stephanie Seminara, MDPrincipal InvestigatorMassachusetts General Hospital
5 Previous Clinical Trials
732 Total Patients Enrolled

Frequently Asked Questions

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

Are octogenarians able to enroll in this particular clinical trial?

"The age range for people eligible to enroll in this clinical trial is 18-45. In comparison, there are 8 ongoing trials for minors and 47 different trials seeking senior participants."

Answered by AI

To date, how many individuals have enrolled in this clinical trial?

"Yes. The clinical trial in question is currently looking for participants, with the first posting on September 22nd, 2017 and the most recent update being June 29th, 2022. So far, 1 location has admitted 60 patients."

Answered by AI

Are there any more slots open for participants in this research project?

"The available information does seem to show that the study is still recruiting patients. According to the latest update on 6/29/2022, they are looking for 60 individuals from 1 location."

Answered by AI

Are there other studies that have used Kisspeptin 112-121 as a treatment?

"There are currently 49 ongoing studies for Kisspeptin 112-121. Out of these, 11 have progressed to Phase 3 trials. The majority of research facilities for this treatment are located in Chicago, but there are 1321 total locations running clinical trials worldwide."

Answered by AI

Is there a high risk associated with Kisspeptin 112-121?

"Because there is only some data supporting safety and none supporting efficacy, our team at Power has rated Kisspeptin 112-121 a 2."

Answered by AI

Might I be eligible to take part in this research study?

"Eligible participants for this study of hypogonadism must be between 18 and 45 years old. Sixty individuals are required for the trial in total."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Administration of Kisspeptin in Patients With Hyperprolactinemia
Stephanie B. Seminara, MD 2017. "Administration of Kisspeptin in Patients With Hyperprolactinemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02956447.
~5 spots leftby Apr 2025
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