Phase 2
N=36
Administration of Kisspeptin in Patients With Hyperprolactinemia
Hyperprolactinemia · Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT02956447 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours — 3.000 pulses per 10 hour period
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Kisspeptin 112-121 (Drug); GnRH (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours |
3.000 | — |
| PRIMARY Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin |
3 | — |
| SECONDARY Average Change in LH Pulse Amplitude |
-0.5764 | — |
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 12-hour period with intravenous (IV) kisspeptin administration). Subjects in the second group will receive subcutaneous (SC) kisspeptin every 90 minutes for eight days.
Eligibility Criteria
Inclusion/Exclusion Criteria:
- confirmed diagnosis of elevated levels of prolactin measured via blood test,
- no pituitary adenoma OR a microprolactinoma ( 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.
Data sourced from ClinicalTrials.gov (NCT02956447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.