Reproductive DisorderPhase 1NCT05971849
Dampening the Reproductive Axis With Continuous Kisspeptin
A Phase 1 study testing kisspeptin 112-121 in people with Reproductive Disorder and PCOS, run by Stephanie B. Seminara, MD at 1 site in United States.
Trial summary
The goal of this study is to assess response to kisspeptin as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals with polycystic ovarian syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Reproductive Disorder, PCOS, Polycystic Ovary Syndrome
- What is being tested?
- kisspeptin 112-121
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2023to 27 Apr 2024
- 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
- Ages 18-45 years
- A history of clinical diagnosis of PCOS or equivalent clinical features
- BMI >18.5 and <35 kg/m2
- Normal blood pressure (systolic BP < 140 mm Hg, diastolic > 90 mm Hg)
- Laboratory studies:
- Negative human chorionic gonadotropin (hCG) pregnancy test prior to kisspeptin administration
- Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for healthy women
- Not using hormonal medication or willing to complete an appropriate washout for that particular medication and its method of 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 its method of administration
- No excessive alcohol consumption (>10 drinks/week) and/or ongoing use of illicit drugs
- Any current use of marijuana will be evaluated by a study medical professional to determine if it is expected to impact study participation
- Not pregnant or trying to become pregnant
- Not breastfeeding
- No history of bilateral oophorectomy (both ovaries removed)
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 assess response to kisspeptin as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals with polycystic ovarian syndrome (PCOS).
Read the detailed description
Assignment: All study subjects will undergo the same interventions. Baseline LH secretion patterns of individuals with PCOS will be compared to their LH secretion patterns while receiving a kisspeptin infusion.
Delivery of Interventions:
- Prior to the inpatient study visit, the subjects will undergo a review of their medical history, physical exam, and screening laboratories.
- On the day of the study, the subjects will have an intravenous (IV) line placed and
- Undergo up to q10 min blood sampling x 36 hours
- Receive an infusion of kisspeptin x 24 hours
- Receive up to two kisspeptin IV boluses
- Conditions
- Reproductive Disorder, PCOS, Polycystic Ovary Syndrome
- Being tested
- kisspeptin 112-121
- Keywords
- reproductive disorders, kisspeptin, PCOS
- Medical subject headings
- Polycystic Ovary Syndrome
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
IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin
| Study group | Role | What they receive |
|---|---|---|
| kisspeptin | Experimental | IV administration of kisspeptin 112-121; 24-hour infusion, up to 2 boluses. 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 LH pulse frequency
Average change in LH pulse frequency before and during kisspeptin infusion
Measured: 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion
Average change in LH pulse amplitude
Average change in LH pulse amplitude before and during kisspeptin infusion
Measured: 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start6 Oct 2023
- Primary completion27 Apr 2024
- Study completion27 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive DisorderStudies 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
- 8 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 B Seminara, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971849
- Sponsor's protocol ID
- 2023P001356
- Status last verified
- Nov 2025
- First submitted
- 17 Jul 2023
- Last updated
- 5 Nov 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 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dampening the Reproductive Axis With Continuous Kisspeptin
- ClinicalTrials.gov ID
- NCT05971849
- Acronym / sponsor ID
- 2023P001356
- Conditions
- Reproductive Disorder, PCOS, Polycystic Ovary Syndrome
- Keywords
- reproductive disorders, kisspeptin, PCOS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Stephanie B. Seminara, MDUniversity, hospital or other
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 27 Apr 2024 (actual)
- Study completion
- 27 Apr 2024 (actual)
- First posted
- 2 Aug 2023 (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 assess response to kisspeptin as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals with polycystic ovarian syndrome (PCOS).
Detailed description
Assignment: All study subjects will undergo the same interventions. Baseline LH secretion patterns of individuals with PCOS will be compared to their LH secretion patterns while receiving a kisspeptin infusion.
Delivery of Interventions:
- Prior to the inpatient study visit, the subjects will undergo a review of their medical history, physical exam, and screening laboratories.
- On the day of the study, the subjects will have an intravenous (IV) line placed and
- Undergo up to q10 min blood sampling x 36 hours
- Receive an infusion of kisspeptin x 24 hours
- Receive up to two kisspeptin IV boluses
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| kisspeptin | Experimental | Drug: kisspeptin 112-121IV administration of kisspeptin 112-121; 24-hour infusion, up to 2 boluses. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 45-54IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin | Drug | kisspeptin |
Primary outcome
Average change in LH pulse frequency
Time frame: 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion
Average change in LH pulse frequency before and during kisspeptin infusion
Average change in LH pulse amplitude
Time frame: 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion
Average change in LH pulse amplitude before and during kisspeptin 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 5 Nov 2025.
- 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 in people with Reproductive Disorder and PCOS, 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?
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 5 Nov 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?
Average change in LH pulse frequency (time frame: 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion). 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 5 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.