Primary outcomeMean· Hours 0-8
Endogenous LH Pulse Amplitude
| Group | Value (mIU/mL) |
|---|---|
| Kisspeptin, GnRH | not posted |
Trial · Interventional
TerminatedPhase 1Results postedRegistry dataRecall by Genotype: Neuropeptide Stimulation
This trial was stopped early.
Reason given at the registry: The study team no longer has access to GnRH. The study has been altered to account for this change and is no longer a clinical trial.
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 1
- Enrollment
- 16 participants (actual)
- Sponsor
- Stephanie B. Seminara, MD · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 20 Oct 2023
- Primary completion
- 29 May 2024
- Completion
- 29 May 2024
- First posted
- 13 Jun 2023
- Last update posted
- 6 Mar 2026
- Conditions
- Reproductive Disorder
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
202320242025
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The objective of this protocol is to assess response to kisspeptin and gonadotropin-releasing hormone (GnRH) stimulation testing as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals who carry variants in genes related to infertility.
Interventions
- kisspeptin 112-121Drug
- GnRHDrug
Arms1
Experimental
kisspeptin, GnRH
IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.
Primary outcomes2
Outcomes the sponsor listed as primary.
Endogenous LH Pulse Amplitude
Time frame · Hours 0-8
Registry description
Average amplitude of LH pulses at baseline
Kisspeptin-induced LH Pulse Amplitude
Time frame · Hours 8-11
Registry description
Amplitude of LH pulse in response to kisspeptin
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Hours 8-11
Kisspeptin-induced LH Pulse Amplitude
| Group | Value (mIU/mL) |
|---|---|
| Kisspeptin, GnRH | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Kisspeptin, GnRHIV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus. | 0 / 16 | 0 / 16 | 1 / 16 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 55 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* No prescription medications that could interfere with hypothalamic reproductive function
* No illicit drug use
* No excessive alcohol consumption (more than 10 drinks/week)
* No history of an allergic medication reaction requiring emergency medical care
* Normal blood pressure reading (systolic blood pressure \< 140 mm Hg, diastolic \< 90 mm Hg)
* White blood cell, platelet counts, prolactin, and thyroid-stimulating hormone (TSH) between 90% of the lower limit and 110% of the upper limit of the reference range
* Normal hemoglobin
* Blood urea nitrogen (BUN), creatinine not elevated
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) within 3 times upper limit of normal
* Enrolled in the Partners HealthCare Biobank and genotypically characterized
* For women
* No oral contraceptives for at least 1 month
* No contraceptive implants for at least 3 months
* Not breastfeeding and not pregnant
* Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration)
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