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Trial · Interventional

CompletedPhase 1Registry data

Dampening the Reproductive Axis With Continuous Kisspeptin

NCTNCT05971849 (opens ClinicalTrials.gov in a new tab)Other id2023P001356
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States

Start
6 Oct 2023
Primary completion
27 Apr 2024
Completion
27 Apr 2024
First posted
2 Aug 2023
Last update posted
5 Nov 2025
Conditions
Reproductive Disorder · PCOS · Polycystic Ovary Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. Ph 1

    Dampening the Reproductive Axis With Continuous Kisspeptin

    NCT05971849

    6 Oct 2023 to 27 Apr 2024

Registry summary

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

The goal of this study is to assess response to kisspeptin as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals with polycystic ovarian syndrome (PCOS).

Interventions

  • kisspeptin 112-121Drug

Arms1

  • Experimental

    kisspeptin

    IV administration of kisspeptin 112-121; 24-hour infusion, up to 2 boluses.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Average change in LH pulse frequency

    Time frame · 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion

    Registry description

    Average change in LH pulse frequency before and during kisspeptin infusion

  2. Average change in LH pulse amplitude

    Time frame · 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion

    Registry description

    Average change in LH pulse amplitude before and during kisspeptin infusion

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
* Ages 18-45 years * A history of clinical diagnosis of PCOS or equivalent clinical features * BMI \>18.5 and \<35 kg/m2 * Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \> 90 mm Hg) * Laboratory studies: * Negative human chorionic gonadotropin (hCG) pregnancy test prior to kisspeptin administration * Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for healthy women * Not using hormonal medication or willing to complete an appropriate washout for that particular medication and its method of 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 its method of administration * No excessive alcohol consumption (\>10 drinks/week) and/or ongoing use of illicit drugs • Any current use of marijuana will be evaluated by a study medical professional to determine if it is expected to impact study participation * Not pregnant or trying to become pregnant * Not breastfeeding * No history of bilateral oophorectomy (both ovaries removed)

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