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Trial · Interventional

CompletedPhase 1Registry data

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Short name KASPR

Overview

Status
Completed
Phase
Phase 1
Enrollment
13 participants (actual)
Sponsor
Stephanie B. Seminara, MD · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
16 Dec 2022
Primary completion
31 Aug 2025
Completion
31 Aug 2025
First posted
1 Dec 2022
Last update posted
3 Oct 2025
Conditions
Hypothalamic Amenorrhea · Hypogonadotropic Hypogonadism

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20222023202420252026
  1. Ph 1

    KASPR

    NCT05633966

    16 Dec 2022 to 31 Aug 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.

Interventions

  • Kisspeptin 112-121Drug

Arms1

  • Experimental

    Kisspeptin pump

    SC administration of kisspeptin for two weeks (pulsatile)

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 2 weeks

    Registry description

    Mature follicle achievement is defined as evidence of a follicle with maximum diameter ≥18 mm. Evidence of ovulation is defined as detection of a corpus luteum on ultrasound in combination with elevated progesterone level.

Secondary outcomes(1)
  1. Change of luteinizing hormone (LH) pulse amplitude

    Time frame · 2 weeks

    Registry description

    Difference in LH amplitude on the first day of kisspeptin administration vs the last day of kisspeptin administration

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Acquired hypogonadotropic hypogonadism (hypothalamic amenorrhea, aka functional hypothalamic amenorrhea) • Confirmed diagnosis by medical provider supported by low sex steroids in the setting of low or inappropriately normal gonadotropins\] * Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg) * Laboratory Studies: * Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women * Negative serum hCG pregnancy test at screening (additional urine pregnancy test will be conducted prior to drug administration) * No current or recent use of a medication that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and method of administration Exclusion Criteria: * Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol * Excessive alcohol consumption (\>10 drinks/week) and/or active use of illicit drugs • Any active use of marijuana will be evaluated by a study medical professional to determine if it may impact study participation. * Pregnant or trying to become pregnant * Breast feeding * History of: bilateral oophorectomy (both ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding

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