Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

NCT05633966 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2022P001039
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypothalamic Amenorrhea; Hypogonadotropic Hypogonadism

Keywords

Hypothalamic Amenorrhea; Hypogonadotropic Hypogonadism; Kisspeptin

Outcome Measures

Primary Outcomes (1)

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

  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.

  2 weeks

Secondary Outcomes (1)

• Change of luteinizing hormone (LH) pulse amplitude

  2 weeks

Study Arms (1)

Kisspeptin pump

EXPERIMENTAL

SC administration of kisspeptin for two weeks (pulsatile)

Drug: Kisspeptin 112-121

Interventions

Kisspeptin 112-121 DRUG

SC administration of kisspeptin for two weeks (pulsatile, approximately every 90 minutes)

Also known as: metastin 45-54

Kisspeptin pump

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephanie B. Seminara, MD: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Stephanie Seminara, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: December 16, 2022
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)