KASPR: Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

• Sponsor: Stephanie B. Seminara, MD (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05633966
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The investigators are recruiting women with hypothalamic amenorrhea or Idiopathic Hypogonadotropic Hypogonadism. Kisspeptin will be administered subcutaneously (SC) for 2-weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (q10 min for up to 2hr) will be performed to assess the physiologic response to kisspeptin over time.

Condition or Disease	Intervention/Treatment	Phase
Hypothalamic Amenorrhea; Hypogonadotropic Hypogonadism	Drug: Kisspeptin 112-121	Phase 1

Detailed Description

Assignment: All study subjects will undergo the same interventions.

Delivery of Interventions:

• The subject will undergo a review of their medical history, physical exam, and screening laboratories.

• A pelvic ultrasound will be performed to assess baseline follicular size.

• A pump will be placed to administer pulsatile SC kisspeptin for two weeks.

• During the course of kisspeptin administration, subjects will 1)Undergo q10 min blood sampling (approximately 4 sessions, 2 hours each) 2) Undergo pelvic ultrasounds (approximately 4 sessions)

• Optional q10 min sampling up to 10 hours may take place before and after the course of kisspeptin

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
• Anticipated Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Kisspeptin pump SC administration of kisspeptin for two weeks (pulsatile, every 90 minutes)	Drug: Kisspeptin 112-121; SC administration of kisspeptin for two weeks (pulsatile, every 90 minutes); Other Names: metastin 45-54

Outcome Measures

Primary Outcome Measures

1. The proportion of participants that achieve development of a mature follicle or show evidence of ovulation [2 weeks]

   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 Outcome Measures

1. Change of LH pulse amplitude [2 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Congenital IHH or acquired HH (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: 1)Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women 2) Negative serum hCG pregnancy test at screening (additional urine pregnancy test will be conducted prior to drug administration)

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

• History of a medication reaction requiring emergency medical care

• Excessive alcohol consumption (>10 drinks/week) and/or active use of illicit drugs 1) Any active use of marijuana will be evaluated by a study medical professional to determine if it may impact study participation. Individuals who regularly use marijuana may be asked to washout as referenced in the medication washout section below

• Pregnant or trying to become pregnant

• Breast feeding

• History of bilateral oophorectomy (ovaries were removed)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Stephanie B. Seminara, MD

Investigators

• Principal Investigator: Stephanie B Seminara, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stephanie B. Seminara, MD, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Canter for Reproductive Medicine, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT05633966
• Other Study ID Numbers: 2022P001039
• First Posted: Dec 1, 2022
• Last Update Posted: Dec 9, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Canter for Reproductive Medicine, Massachusetts General Hospital: Hypothalamic Amenorrhea; Hypogonadotropic Hypogonadism; Kisspeptin
• Additional relevant MeSH terms: Hypogonadism; Amenorrhea

Study Results

No Results Posted as of Dec 9, 2022