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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
Must not have
History of bilateral oophorectomy (ovaries were removed)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had both of my ovaries removed.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The proportion of participants that achieve development of a mature follicle or show evidence of ovulation
Secondary study objectives
Change of luteinizing hormone (LH) pulse amplitude

Side effects data

From 2023 Phase 2 trial • 36 Patients • NCT02956447
13%
Upper Respiratory Infection
13%
Pain of skin
13%
Headache
7%
Nausea
7%
Myalgia
7%
Dizziness
7%
Muscle Cramp
100%
80%
60%
40%
20%
0%
Study treatment Arm
Subcutaneous Kisspeptin
Intravenous Kisspeptin

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 pumpExperimental Treatment1 Intervention
SC administration of kisspeptin for two weeks (pulsatile)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Kisspeptin 112-121
2017
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Stephanie B. Seminara, MDLead Sponsor
9 Previous Clinical Trials
787 Total Patients Enrolled
Stephanie Seminara, MDPrincipal InvestigatorMassachusetts General Hospital
5 Previous Clinical Trials
744 Total Patients Enrolled
Stephanie B Seminara, MDPrincipal InvestigatorMassachusetts General Hospital
8 Previous Clinical Trials
5,123 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
~13 spots leftby Aug 2025
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