HyperprolactinemiaPhase 2NCT02956447
Administration of Kisspeptin in Patients With Hyperprolactinemia
A Phase 2 study testing Kisspeptin 112-121 and GnRH in people with Hyperprolactinemia and Hypogonadism, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this study is to learn more about how kisspeptin, a naturally occurring hormone, affects women with high levels of prolactin (also called hyperprolactinemia). Subjects in one group will undergo blood sampling every 10 minutes over two 12-hour periods (one 12-hour period without any intervention and one… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hyperprolactinemia, 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
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2017to 29 Jul 2023
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- confirmed diagnosis of elevated levels of prolactin measured via blood test,
- no pituitary adenoma OR a microprolactinoma (<10 mm). Patients with a macroprolactinoma confirmed on MRI imaging will be excluded,
- no history of a medication reaction requiring emergency medical care,
- no illicit drug use or excessive alcohol consumption (>10 drinks/week),
- not currently seeking fertility, breastfeeding or pregnant,
- no history of bilateral oophorectomy,
- willing to complete a dopamine agonist washout and/or oral contraceptive washout,
- normal physical exam and laboratory studies within protocol reference range.
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 learn more about how kisspeptin, a naturally occurring hormone, affects women with high levels of prolactin (also called hyperprolactinemia). Subjects in one group will undergo blood sampling every 10 minutes over two 12-hour periods (one 12-hour period without any intervention and one 12-hour period with intravenous (IV) kisspeptin administration). Subjects in the second group will receive subcutaneous (SC) kisspeptin every 90 minutes for eight days.
- Conditions
- Hyperprolactinemia, Hypogonadism
- Being tested
- Kisspeptin 112-121, GnRH
- Keywords
- Kisspeptin, Hyperprolactinemia, GnRH, Hypogonadism
- Medical subject headings
- Hyperprolactinemia, 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
0.313 ug/kg - 2 ug/kg IV or SC
GnRHDrug
Also called gonadotropin-releasing hormone
0.075 ug/kg IV
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Kisspeptin | Experimental | Blood sampling every 10 minutes over two 12-hour periods. One 12-hour period without any intervention. One 12-hour period consisting of administration of 10 boluses of kisspeptin 112-121 intravenously (IV). Receives: Drug: Kisspeptin 112-121; Drug: GnRH |
| Subcutaneous Kisspeptin | Experimental | Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days. Receives: Drug: Kisspeptin 112-121 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours
Average change in LH pulse frequency at baseline and during kisspeptin IV administration
Measured: Up to 14 days
Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin
Ultrasound evidence of increased follicle size over the course of SC kisspeptin administration
Measured: Evaluated over eight days
Secondary outcomes (1)
Average Change in LH Pulse Amplitude
Average change in LH pulse amplitude at baseline and during IV kisspeptin administration
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start17 Nov 2017
- Primary completion28 Jun 2023
- Study completion29 Jul 2023
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 HyperprolactinemiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie B. Seminara, MD, Massachusetts General Hospital
- Investigators
- Stephanie Seminara, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956447
- Sponsor's protocol ID
- 2016P002281
- Other IDs
- FD-R-5712
- Status last verified
- Sep 2024
- First submitted
- 1 Nov 2016
- Last updated
- 1 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After primary results are published, the authors will provide individual participant data upon request as long as it does not conflict with state or institutional regulations
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Kisspeptin in Patients With Hyperprolactinemia
- ClinicalTrials.gov ID
- NCT02956447
- Acronym / sponsor ID
- 2016P002281
- Conditions
- Hyperprolactinemia, Hypogonadism
- Keywords
- Kisspeptin, Hyperprolactinemia, GnRH, Hypogonadism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 29 Jul 2023 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Posted 20 Aug 2024
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 learn more about how kisspeptin, a naturally occurring hormone, affects women with high levels of prolactin (also called hyperprolactinemia). Subjects in one group will undergo blood sampling every 10 minutes over two 12-hour periods (one 12-hour period without any intervention and one 12-hour period with intravenous (IV) kisspeptin administration). Subjects in the second group will receive subcutaneous (SC) kisspeptin every 90 minutes for eight days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Kisspeptin | Experimental | Drug: Kisspeptin 112-121, Drug: GnRHBlood sampling every 10 minutes over two 12-hour periods. One 12-hour period without any intervention. One 12-hour period consisting of administration of 10 boluses of kisspeptin 112-121 intravenously (IV). |
| Subcutaneous Kisspeptin | Experimental | Drug: Kisspeptin 112-121Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- confirmed diagnosis of elevated levels of prolactin measured via blood test,
- no pituitary adenoma OR a microprolactinoma (<10 mm). Patients with a macroprolactinoma confirmed on MRI imaging will be excluded,
- no history of a medication reaction requiring emergency medical care,
- no illicit drug use or excessive alcohol consumption (>10 drinks/week),
- not currently seeking fertility, breastfeeding or pregnant,
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 45-540.313 ug/kg - 2 ug/kg IV or SC | Drug | Intravenous Kisspeptin, Subcutaneous Kisspeptin |
| GnRHAlso: gonadotropin-releasing hormone0.075 ug/kg IV | Drug | Intravenous Kisspeptin |
Primary outcome
Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours
Time frame: Up to 14 days
Average change in LH pulse frequency at baseline and during kisspeptin IV administration
Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin
Time frame: Evaluated over eight days
Ultrasound evidence of increased follicle size over the course of SC kisspeptin administration
1 secondary outcome
Average Change in LH Pulse Amplitude
Time frame: Up to 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. After primary results are published, the authors will provide individual participant data upon request as long as it does not conflict with state or institutional regulations
Related trials for Hyperprolactinemia
RecruitingPhase 3
Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
Prolactinoma, Prolactin Excess
Not yet recruitingPhase 4
Carbergoline for Antipsychotic Induced Hyperprolactinemia.
Scizophrenia
Active, not recruitingPhase 1
A Study on Bioequivalence of Cabergoline Tablets in Human Body
Hyperprolactinemia
RecruitingPhase 3
A Phase III Clinical Study of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets
Hyperprolactinemia
RecruitingPhase 4
Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment
Prolactinoma
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 2 study testing Kisspeptin 112-121 and GnRH in people with Hyperprolactinemia and Hypogonadism, run by Massachusetts General Hospital 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 8 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 1 Oct 2024. 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 20 Aug 2024). 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 Number of Luteinizing Hormone (LH) Pulses Over 10 Hours (time frame: Up to 14 days). The study lists 2 primary outcomes in all. 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 1 Oct 2024.