Recruiting
Phase 2

Kisspeptin

Sponsor:

Stephanie B. Seminara, MD

Code:

NCT05896293

Conditions

Hypogonadotropic Hypogonadism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

kisspeptin 112-121

leuprolide acetate

Study Details

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 men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time.

Funding Source: FDA OOPD

Conditions

Hypogonadotropic Hypogonadism

Study ID

NCT05896293

Start date

Feb 3, 2023

Status verified date

Jul, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Congenital IHH
  • 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)
  • 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
  • If applicable, willing to use birth control methods (as approved by a study medical professional) during the entire study and for one month after the last dose of study drug

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)
  • Active use of illicit drugs (not including marijuana)
  • For women:
  • 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

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: kisspeptin pump

SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes); administration of a single shot of leuprolide acetate (previously GnRH was used in this study)

Interventions

kisspeptin 112-121

SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes)

leuprolide acetate

Single SC bolus

Primary outcome measure

  • Average change in luteinizing hormone (LH) pulse amplitude [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Study Coordinator

617-726-1895MGHKisspeptinResearch@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Study Coordinator

617-726-1895MGHKisspeptinResearch@partners.org

More Information

Sponsor

Stephanie B. Seminara, MD

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Hypogonadotropic Hypogonadism
  • Kisspeptin
  • Idiopathic Hypogonadotropic Hypogonadism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stephanie B. Seminara, MD on 2026-07-13.