Hypothalamic AmenorrheaPhase 1KASPRNCT05633966
Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
A Phase 1 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
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2022to 31 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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
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) 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
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.
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.
Measured: 2 weeks
Secondary outcomes (1)
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 posted1 Dec 2022
- Study start16 Dec 2022
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephanie B. Seminara, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephanie B. Seminara, MD, Massachusetts General Hospital
- Investigators
- Stephanie Seminara, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633966
- Sponsor's protocol ID
- 2022P001039
- Acronym
- KASPR
- Status last verified
- Sep 2025
- First submitted
- 21 Nov 2022
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
- ClinicalTrials.gov ID
- NCT05633966
- Acronym / sponsor ID
- KASPR / 2022P001039
- Keywords
- Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism, Kisspeptin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Stephanie B. Seminara, MDUniversity, hospital or other
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kisspeptin pump | Experimental | Drug: Kisspeptin 112-121SC administration of kisspeptin for two weeks (pulsatile) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Acquired hypogonadotropic hypogonadism (hypothalamic amenorrhea, aka functional hypothalamic amenorrhea)
- Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
- Laboratory Studies:
- 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
Key exclusion criteria (6 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kisspeptin 112-121Also: metastin 45-54SC administration of kisspeptin for two weeks (pulsatile, approximately every 90 minutes) | Drug | Kisspeptin pump |
Primary outcome
The proportion of participants that achieve development of a mature follicle or show evidence of ovulation
Time frame: 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.
1 secondary outcome
Change of luteinizing hormone (LH) pulse amplitude
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Hypothalamic Amenorrhea
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A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
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Observation of Environment and Reproductive-Endocrine Effects
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Seminara, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants that achieve development of a mature follicle or show evidence of ovulation (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.