Hypothalamic AmenorrheaPhase 2NCT07224438
Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea
A Phase 2 study testing kisspeptin 112-121 in people with Hypothalamic Amenorrhea and Hypogonadotropic Hypogonadism, run by Stephanie B. Seminara, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism
- What is being tested?
- kisspeptin 112-121
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2025to May 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Ages 18-45 years
- Acquired HH (hypothalamic amenorrhea, aka functional hypogonadotropic hypogonadism)
- Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
- Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women
- Negative serum hCG pregnancy test
- No current or recent use of a medication (including hormonal replacement) 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
- 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
Who cannot join
- 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
- Pregnant
- Trying to become pregnant during protocol participation
- Breast feeding
- History of any of the following: bilateral oophorectomy (ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Study Coordinator, 617-643-2308, MGHKisspeptinResearch@partners.org
About this study
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.
Read the 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
- Undergo q10 min blood sampling (approximately 4 sessions, 2 hours each)
- Undergo pelvic ultrasounds (approximately 4 sessions)
- Optional q10 min sampling up to 10 hours may take place before and after the course of kisspeptin
- Being tested
- kisspeptin 112-121
- Keywords
- hypothalamic amenorrhea, hypogonadotropic hypogonadism, kisspeptin
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kisspeptin 112-121Drug
Also called Metastin 45-54
SC administration of kisspeptin for two weeks (pulsatile, approximately every 90 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Kisspeptin pump | Experimental | SC administration of kisspeptin for two weeks (pulsatile) Receives: Drug: kisspeptin 112-121 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of luteinizing hormone (LH) pulse amplitude
Difference in LH amplitude on the first day of kisspeptin administration vs the last day of kisspeptin administration
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start9 Dec 2025
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothalamic AmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stephanie B. Seminara, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Stephanie B. Seminara, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224438
- Sponsor's protocol ID
- 565178
- Other IDs
- R37HD043341
- Status last verified
- Jul 2026
- First submitted
- 3 Nov 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No