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Dampening the Reproductive Axis With Continuous Kisspeptin

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ClinicalTrials.gov Identifier: NCT05971849
Recruitment Status : Recruiting
First Posted : August 2, 2023
Last Update Posted : October 19, 2023
Sponsor:
Information provided by (Responsible Party):
Stephanie B. Seminara, MD, Massachusetts General Hospital

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Reproductive Disorder PCOS Polycystic Ovary Syndrome Drug: kisspeptin 112-121 Drug: GnRH Phase 1

Detailed Description:

Assignment: All study subjects will undergo the same interventions. Baseline LH secretion patterns of individuals with PCOS will be compared to their LH secretion patterns while receiving a kisspeptin infusion.

Delivery of Interventions:

  • Prior to the inpatient study visit, the subjects will undergo a review of their medical history, physical exam, and screening laboratories.

  • On the day of the study, the subjects will have an intravenous (IV) line placed and

    • Undergo up to q10 min blood sampling x 36 hours
    • Receive an infusion of kisspeptin x 24 hours
    • Receive up to two kisspeptin IV boluses
    • Receive up to one gonadotropin-releasing hormone (GnRH) IV bolus
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Dampening the Reproductive Axis With Continuous Kisspeptin
Actual Study Start Date : October 6, 2023
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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Arm Intervention/treatment
Experimental: kisspeptin, GnRH
IV administration of kisspeptin 112-121; 24-hour infusion. IV administration of GnRH; up to one bolus.
 Drug: kisspeptin 112-121
IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin
Other Name: metastin 45-54

Drug: GnRH
Up to one IV bolus of GnRH
Other Name: gonadotropin-releasing hormone


Outcome Measures
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Primary Outcome Measures :
  1. Average change in LH pulse frequency [ Time Frame: 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion ]
    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 ]
    Average change in LH pulse amplitude before and during kisspeptin infusion


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • 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 history of a medication reaction that required emergency medical care

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05971849


Contacts
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Contact: Study Coordinator 617-643-2308 MGHKisspeptinResearch@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Study Coordinator    617-643-2308    MGHKisspeptinResearch@partners.org   
Sponsors and Collaborators
Stephanie B. Seminara, MD
Investigators
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Principal Investigator: Stephanie B Seminara, MD Massachusetts General Hospital
More Information
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Responsible Party: Stephanie B. Seminara, MD, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT05971849    
Other Study ID Numbers: 2023P001356
First Posted: August 2, 2023    Key Record Dates
Last Update Posted: October 19, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephanie B. Seminara, MD, Massachusetts General Hospital:
reproductive disorders
kisspeptin
PCOS
GnRH
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Gonadal Disorders
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs