Clinical trial · Interventional
Dampening the Reproductive Axis With Continuous Kisspeptin
NCT05971849CI-TRIAL-00096991completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCOS | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
| Reproductive Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| kisspeptin 112-121 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- kisspeptin
- description
- IV administration of kisspeptin 112-121; 24-hour infusion, up to 2 boluses.
- interventionNames
- Drug: kisspeptin 112-121
Primary outcomes (2)
- measure
- Average change in LH pulse frequency
- timeFrame
- 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion
- description
- Average change in LH pulse frequency before and during kisspeptin infusion
- measure
- Average change in LH pulse amplitude
- timeFrame
- 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion
- description
- Average change in LH pulse amplitude before and during kisspeptin infusion
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
* 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)
References
Publications (0)
Data not yet available
No reference posted for this study.