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Hormone Therapy

Subcutaneous Kisspeptin for Fertility Issues (KASPR Trial)

Phase 1

Recruiting

Led By Stephanie Seminara, MD

Research Sponsored by Stephanie B. Seminara, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acquired hypogonadotropic hypogonadism (hypothalamic amenorrhea, aka functional hypothalamic amenorrhea) with confirmed diagnosis by medical provider supported by low sex steroids in the setting of low or inappropriately normal gonadotropins

Not using hormonal replacement or willing to complete an appropriate washout for that particular medication and method of administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

KASPR Trial Summary

This trial is studying how kisspeptin affects women with fertility issues. It'll involve injections, ultrasounds & frequent blood sampling.

Who is the study for?

This trial is for women with reproductive issues like low testosterone, amenorrhea, or hypogonadotropic hypogonadism. Participants should have a confirmed diagnosis of hypothalamic amenorrhea, normal blood pressure, and hemoglobin levels within the acceptable range. They must not be pregnant, breastfeeding, using hormonal replacements without washout period or any drugs affecting the reproductive system.Check my eligibility

What is being tested?

The study tests if kisspeptin can trigger hormone release and egg release in ovaries of women with hypothalamic amenorrhea. Kisspeptin will be given subcutaneously in pulses over two weeks while monitoring ovarian response and hormone levels through frequent blood tests and ultrasound.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions at the injection site due to subcutaneous administration of kisspeptin or GnRH. Regular monitoring during the trial aims to identify any adverse physiological responses.

KASPR Trial Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with a specific type of hormone deficiency affecting my reproductive system.

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I am not on hormonal replacement or willing to stop it for the required time.

KASPR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The proportion of participants that achieve development of a mature follicle or show evidence of ovulation

Secondary outcome measures

Change of luteinizing hormone (LH) pulse amplitude

KASPR Trial Design

1Treatment groups

Experimental Treatment

Group I: Kisspeptin pumpExperimental Treatment2 Interventions

SC administration of kisspeptin for two weeks (pulsatile, every 90 minutes)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GnRH

2017

Completed Phase 2

~320

Kisspeptin 112-121

2017

Completed Phase 2

~40

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stephanie B. Seminara, MDLead Sponsor

9 Previous Clinical Trials

1,290 Total Patients Enrolled

Stephanie Seminara, MDPrincipal InvestigatorMassachusetts General Hospital

5 Previous Clinical Trials

718 Total Patients Enrolled

Stephanie B Seminara, MDPrincipal InvestigatorMassachusetts General Hospital

8 Previous Clinical Trials

5,556 Total Patients Enrolled

Media Library

Kisspeptin 112-121 (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05633966 — Phase 1

Hypogonadotropic Hypogonadism Research Study Groups: Kisspeptin pump

Hypogonadotropic Hypogonadism Clinical Trial 2023: Kisspeptin 112-121 Highlights & Side Effects. Trial Name: NCT05633966 — Phase 1

Kisspeptin 112-121 (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05633966 — 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 federal drug administration approved Kisspeptin for public use?

"With limited safety and efficacy data, the Kisspeptin pump has been rated as a 1 on our scale of 1 to 3. This also indicates that this is an early-stage trial (Phase 1)."

Answered by AI

Is it possible for me to participate in this clinical investigation?

"This trial is opening up 50 positions for individuals suffering from hypogonadism and aged between 18-45. Applicants must meet a series of prerequisites including but not limited to: having a confirmed diagnosis of Congenital IHH or acquired HH (hypothalamic amenorrhea, aka functional hypothalmic amenorrhea), maintaining normal blood pressure readings, demonstrating no signs of pregnancy in both serum hCG tests and urine pregnancy test at screening, and refraining from using any hormonal replacements or medications that could potentially affect the reproductive axis before recruitment."

Answered by AI

Do applicants to this trial need to be of a certain age or younger?

"This trial is open to willing participants who are at least 18 years of age, but not exceeding 45."

Answered by AI

Are participants being actively sought out for this research project?

"The evidence posted to clinicaltrials.gov demonstrates that this medical trial is still in its recruitment phase, with the first posting on November 1st 2022 and a recent update on November 21st 2022."

Answered by AI

How many participants has the clinical trial recruited thus far?

"Affirmative. Clinicaltrials.gov records reveal that this research endeavor, which was first launched on November 1st 2022, is still welcoming participants. A total of 50 applicants will be admitted from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Stephanie B. Seminara, MD 2022. "Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05633966.

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