Hypogonadotropic HypogonadismPhase 1NCT01952782
Neuropeptides in Human Reproduction
A Phase 1 study testing Kisspeptin 112-121, Naloxone and GnRH in people with Hypogonadotropic Hypogonadism, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators are seeking healthy volunteers and volunteers with reproductive disorders for the study of the role of dynorphin in the reproductive system. Dynorphin is a naturally occurring opioid hormone that is blocked by naloxone. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypogonadotropic Hypogonadism
- What is being tested?
- Kisspeptin 112-121, Naloxone and GnRH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2014to 31 May 2016
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 21-40 (healthy men and regularly cycling women) OR ages 18-75 (men and women with hypogonadotropic hypogonadism (HH))
- Normal blood pressure (systolic BP <140 mm Hg, diastolic BP <90 mm Hg)
- White blood cell, platelets, prolactin, and thyroid stimulating hormone (TSH)within 90%-110% of laboratory reference range
- Negative urine drug screen panel
- Hemoglobin:
- For healthy men and healthy regularly cycling women: normal
Show all 11Show fewer
- For men and women with HH: No less than 0.5 gm/dL below the lower limit of the reference range for normal women
- Blood urea nitrogen (BUN), creatinine, liver function tests not elevated
- For healthy subjects: Normal reproductive function and history
- For healthy subjects: Body Mass Index (BMI) 18.5-30kg/m2
- For subjects with HH: All medical conditions stable and well controlled
Who cannot join
- History of medication reaction requiring emergency medical attention
- Illicit drug use
- Consumption of more than 10 alcoholic drinks per week
- Difficulty with blood draws
- Currently seeking fertility, breastfeeding, or pregnant
- For healthy subjects: history of chronic disease and prescription medication use (with the exception of seasonal allergy medication)
- For subjects with HH: prescription medications known to affect reproductive endocrine function except for those used to treat the subject's reproductive condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The investigators are seeking healthy volunteers and volunteers with reproductive disorders for the study of the role of dynorphin in the reproductive system. Dynorphin is a naturally occurring opioid hormone that is blocked by naloxone.
We hypothesize that naloxone, by blocking dynorphin, will stimulate production of gonadotropin-releasing hormone (GnRH) and kisspeptin, two other naturally occurring reproductive hormones.
- Conditions
- Hypogonadotropic Hypogonadism
- Being tested
- Kisspeptin 112-121, Naloxone, GnRH
- Keywords
- Reproductive disorders, Hypogonadotropic hypogonadism, Kisspeptin, GnRH, Naloxone
- 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
Subjects will receive up to 10 IV doses of kisspeptin 112-121
NaloxoneDrug
Subjects will receive one IV dose of naloxone followed by an IV infusion of naloxone.
GnRHDrug
Also called Gonadotropin-releasing hormone
Subjects will receive up to 10 doses of IV GnRH
| Study group | Role | What they receive |
|---|---|---|
| Naloxone, Kisspeptin, GnRH | Experimental | Intravenous (IV) administration of kisspeptin 112-121, GnRH, and naloxone Receives: Drug: Kisspeptin 112-121; Drug: Naloxone; Drug: GnRH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average difference in luteinizing hormone (LH) concentration before and after kisspeptin
Compares response to kisspeptin on and off naloxone infusion
Measured: Within 30 minutes of administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study start30 Apr 2014
- Primary completion31 May 2016
- Study completion31 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypogonadotropic HypogonadismStudies 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 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 B Seminara, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952782
- Sponsor's protocol ID
- 2013P001543
- Status last verified
- Jul 2024
- First submitted
- 24 Sep 2013
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lippincott MF, Leon S, Chan YM, Fergani C, Talbi R, Farooqi IS, Jones CM, Arlt W, Stewart SE, Cole TR, Terasawa E, Hall JE, Shaw ND, Navarro VM, Seminara SB. Hypothalamic Reproductive Endocrine Pulse Generator Activity Independent of Neurokinin B and Dynorphin Signaling. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4304-4318. doi: 10.1210/jc.2019-00146.
PubMed 31132118Chan YM, Lippincott MF, Kusa TO, Seminara SB. Divergent responses to kisspeptin in children with delayed puberty. JCI Insight. 2018 Apr 19;3(8):e99109. doi: 10.1172/jci.insight.99109. eCollection 2018 Apr 19.
PubMed 29669934
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropeptides in Human Reproduction
- ClinicalTrials.gov ID
- NCT01952782
- Acronym / sponsor ID
- 2013P001543
- Conditions
- Hypogonadotropic Hypogonadism
- Keywords
- Reproductive disorders, Hypogonadotropic hypogonadism, Kisspeptin, GnRH, Naloxone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 30 Apr 2014 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 30 Sep 2013 (estimated)
- 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 investigators are seeking healthy volunteers and volunteers with reproductive disorders for the study of the role of dynorphin in the reproductive system. Dynorphin is a naturally occurring opioid hormone that is blocked by naloxone.
We hypothesize that naloxone, by blocking dynorphin, will stimulate production of gonadotropin-releasing hormone (GnRH) and kisspeptin, two other naturally occurring reproductive hormones.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Naloxone, Kisspeptin, GnRH | Experimental | Drug: Kisspeptin 112-121, Drug: Naloxone, Drug: GnRHIntravenous (IV) administration of kisspeptin 112-121, GnRH, and naloxone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ages 21-40 (healthy men and regularly cycling women) OR ages 18-75 (men and women with hypogonadotropic hypogonadism (HH))
- Normal blood pressure (systolic BP <140 mm Hg, diastolic BP <90 mm Hg)
- White blood cell, platelets, prolactin, and thyroid stimulating hormone (TSH)within 90%-110% of laboratory reference range
- Negative urine drug screen panel
- Hemoglobin:
Key exclusion criteria (7 listed)
- History of medication reaction requiring emergency medical attention
- Illicit drug use
- Consumption of more than 10 alcoholic drinks per week
- Difficulty with blood draws
- Currently seeking fertility, breastfeeding, or pregnant
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 45-54Subjects will receive up to 10 IV doses of kisspeptin 112-121 | Drug | Naloxone, Kisspeptin, GnRH |
| NaloxoneSubjects will receive one IV dose of naloxone followed by an IV infusion of naloxone. | Drug | Naloxone, Kisspeptin, GnRH |
| GnRHAlso: Gonadotropin-releasing hormoneSubjects will receive up to 10 doses of IV GnRH | Drug | Naloxone, Kisspeptin, GnRH |
Primary outcome
Average difference in luteinizing hormone (LH) concentration before and after kisspeptin
Time frame: Within 30 minutes of administration
Compares response to kisspeptin on and off naloxone infusion
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 31 Jul 2024.
- Derived from this study: PubMed 31132118Lippincott MF, Leon S, Chan YM, Fergani C, Talbi R, Farooqi IS, Jones CM, Arlt W, Stewart SE, Cole TR, Terasawa E, Hall JE, Shaw ND, Navarro VM, Seminara SB. Hypothalamic Reproductive Endocrine Pulse Generator Activity Independent of Neurokinin B and Dynorphin Signaling. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4304-4318. doi: 10.1210/jc.2019-00146.
- Derived from this study: PubMed 29669934Chan YM, Lippincott MF, Kusa TO, Seminara SB. Divergent responses to kisspeptin in children with delayed puberty. JCI Insight. 2018 Apr 19;3(8):e99109. doi: 10.1172/jci.insight.99109. eCollection 2018 Apr 19.
- 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 B 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, Naloxone and GnRH in people with Hypogonadotropic 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 11 inclusion and 7 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 31 Jul 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 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?
Average difference in luteinizing hormone (LH) concentration before and after kisspeptin (time frame: Within 30 minutes of administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01952782, which also lists 2 linked publications.
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 31 Jul 2024.