Hypogonadotropic HypogonadismPhase 2NCT04648969
Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism
A Phase 2 study testing kisspeptin 112-121 and GnRH in people with Hypogonadotropic Hypogonadism, run by Stephanie B. Seminara, MD at 1 site in United States.
Trial summary
The goal of this study is to develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypogonadotropic Hypogonadism
- What is being tested?
- kisspeptin 112-121 and GnRH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2019to 31 Aug 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older,
- Confirmed diagnosis of HH with
- Low testosterone or estradiol,
- Low or low-normal gonadotropin levels,
- Thyroid stimulating hormone (TSH) and prolactin within the reference range,
- Absence of abnormal pituitary or hypothalamic findings on Magnetic resonance imaging (MRI),
Show all 21Show fewer
- All other medical conditions stable and well controlled,
- No prescription medications known to affect reproductive endocrine function for at least 2 months or for 5 half-lives of the drug (whichever is shorter) except for medications used to treat the subject's reproductive condition,
- No history of a medication reaction requiring emergency medical care,
- No illicit drug use,
- No excessive alcohol consumption (<10 drinks/week),
- Normal blood pressure (BP), (systolic BP < 140 mm Hg, diastolic < 90 mm Hg),
- White blood cell, platelet counts, and TSH between 90% of the lower limit and 110% of the upper limit of the reference range,
- Prolactin below 110% of the upper limit of the reference range,
- Hemoglobin
- Women: no less than 0.5 gm/dL below the lower limit of the reference range for normal women,
- Men: on adequate testosterone replacement therapy: normal male reference range,
- Blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine transaminase (ALT) not elevated,
- For women,
- Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration),
- Not breastfeeding and not pregnant.
Who cannot join
None listed.
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 develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin.
Read the detailed description
- Assignment: Each study subject will serve as their own control. The order of kisspeptin doses will be randomized within each set/exposure.
- Delivery of Interventions:
- Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. Subjects will also wear a gonadotropin releasing hormone (GnRH) pump prior to the inpatient study visit.
- On the day of the inpatient study, the subjects will
- Undergo q10 min blood sampling for 6 hours,
- Receive kisspeptin intravenous (IV) boluses from hour 6 to hour 44 (20 boluses total),
- Undergo q10 min blood samplings for another 6 hours,
- Receive a single GnRH IV bolus at hour 51.
- Conditions
- Hypogonadotropic Hypogonadism
- Being tested
- kisspeptin 112-121, GnRH
- Keywords
- 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
20 intravenous doses of kisspeptin 112-121 (4 different doses of kisspeptin (randomized) in 5 sets)
GnRHDrug
Also called gonadotropin-releasing hormone
1 intravenous dose of GnRH
| Study group | Role | What they receive |
|---|---|---|
| Experimental: kisspeptin, GnRH | Experimental | • Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus. Receives: Drug: kisspeptin 112-121; Drug: GnRH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Change in Luteinizing Hormone (LH) Pulse Amplitude in Response to Kisspeptin
Change in LH amplitude before, during and after kisspeptin administration
Measured: 52 hours
Secondary outcomes (1)
Average Change in LH Pulse Frequency in Response to Kisspeptin
Change in LH frequency before and after kisspeptin administration
Measured: 52 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start3 May 2019
- 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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypogonadotropic HypogonadismStudies 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
- 18 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, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648969
- Sponsor's protocol ID
- 313509
- Status last verified
- Sep 2025
- First submitted
- 11 Nov 2020
- Last updated
- 26 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism
- ClinicalTrials.gov ID
- NCT04648969
- Acronym / sponsor ID
- 313509
- Conditions
- Hypogonadotropic Hypogonadism
- Keywords
- hypogonadotropic hypogonadism, kisspeptin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Stephanie B. Seminara, MDUniversity, hospital or other
- Study start
- 3 May 2019 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Posted 26 Aug 2026
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 develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin.
Detailed description
- Assignment: Each study subject will serve as their own control. The order of kisspeptin doses will be randomized within each set/exposure.
- Delivery of Interventions:
- Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. Subjects will also wear a gonadotropin releasing hormone (GnRH) pump prior to the inpatient study visit.
- On the day of the inpatient study, the subjects will
- Undergo q10 min blood sampling for 6 hours,
- Receive kisspeptin intravenous (IV) boluses from hour 6 to hour 44 (20 boluses total),
- Undergo q10 min blood samplings for another 6 hours,
- Receive a single GnRH IV bolus at hour 51.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: kisspeptin, GnRH | Experimental | Drug: kisspeptin 112-121, Drug: GnRH• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age 18 years and older,
- Confirmed diagnosis of HH with
- All other medical conditions stable and well controlled,
- No prescription medications known to affect reproductive endocrine function for at least 2 months or for 5 half-lives of the drug (whichever is shorter) except for medications used to treat the subject's reproductive condition,
- No history of a medication reaction requiring emergency medical care,
Key exclusion criteria (0 listed)
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 45-5420 intravenous doses of kisspeptin 112-121 (4 different doses of kisspeptin (randomized) in 5 sets) | Drug | Experimental: kisspeptin, GnRH |
| GnRHAlso: gonadotropin-releasing hormone1 intravenous dose of GnRH | Drug | Experimental: kisspeptin, GnRH |
Primary outcome
Average Change in Luteinizing Hormone (LH) Pulse Amplitude in Response to Kisspeptin
Time frame: 52 hours
Change in LH amplitude before, during and after kisspeptin administration
1 secondary outcome
Average Change in LH Pulse Frequency in Response to Kisspeptin
Time frame: 52 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 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 2 study testing kisspeptin 112-121 and GnRH in people with 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 21 inclusion and 0 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 26 Aug 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Change in Luteinizing Hormone (LH) Pulse Amplitude in Response to Kisspeptin (time frame: 52 hours). 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 26 Aug 2026.