A Phase 2 interventional study of Kisspeptin 112-121 and GnRH in Hyperprolactinemia and Hypogonadism, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment
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.
39 studies on the registry are indexed under Hyperprolactinemia; 4 are open to participants now.
This study's enrollment of 36 is below the median of 60 across 19 interventional studies indexed under Hyperprolactinemia.
Browse Hyperprolactinemia studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion/Exclusion Criteria:
Blood sampling every 10 minutes over two 12-hour periods. One 12-hour period without any intervention. One 12-hour period consisting of administration of 10 boluses of kisspeptin 112-121 intravenously (IV).
Drug: Kisspeptin 112-121 · Drug: GnRH
Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days.
Drug: Kisspeptin 112-121
0.313 ug/kg - 2 ug/kg IV or SC
Also known as: Metastin 45-54
0.075 ug/kg IV
Also known as: gonadotropin-releasing hormone
Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours
Average change in LH pulse frequency at baseline and during kisspeptin IV administration
Time frame: Up to 14 days
Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin
Ultrasound evidence of increased follicle size over the course of SC kisspeptin administration
Time frame: Evaluated over eight days
Average Change in LH Pulse Amplitude
Average change in LH pulse amplitude at baseline and during IV kisspeptin administration
Time frame: Up to 14 days
| Milestone | Intravenous Kisspeptin | Subcutaneous Kisspeptin |
|---|---|---|
| Started | 21 | 15 |
| Completed | 10 | 5 |
| Not completed | 11 | 10 |
Average change in LH pulse frequency at baseline and during kisspeptin IV administration
| pulses per 10 hour period | Intravenous Kisspeptin | Subcutaneous Kisspeptin |
|---|---|---|
| Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours | 3.000 ± 3.066 | — |
Ultrasound evidence of increased follicle size over the course of SC kisspeptin administration
| Participants | Subcutaneous Kisspeptin | Intravenous Kisspeptin |
|---|---|---|
| Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin | 3 | — |
Average change in LH pulse amplitude at baseline and during IV kisspeptin administration
| mIU/mL | Intravenous Kisspeptin | Subcutaneous Kisspeptin |
|---|---|---|
| Average Change in LH Pulse Amplitude | -0.5764 ± 8.061 | — |
Collected over From the time of documented informed consent until completion of study procedures (an average of 3 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intravenous Kisspeptin | 0/21 (0%) | 0/21 (0%) | 10/21 (47.6%) |
| Subcutaneous Kisspeptin | 0/15 (0%) | 0/15 (0%) | 4/15 (26.7%) |
| Event | Intravenous Kisspeptin | Subcutaneous Kisspeptin |
|---|---|---|
| HeadacheNervous system disorders | 5/21 | 2/15 |
| Pain of skinSkin and subcutaneous tissue disorders | 3/21 | 2/15 |
| Upper Respiratory InfectionInfections and infestations | 2/21 | 2/15 |
| FatigueGeneral disorders | 2/21 | 0/15 |
| NauseaGastrointestinal disorders | 0/21 | 1/15 |
| DizzinessNervous system disorders | 1/21 | 1/15 |
| Muscle CrampMusculoskeletal and connective tissue disorders | 1/21 | 1/15 |
| MyalgiaMusculoskeletal and connective tissue disorders | 0/21 | 1/15 |
| Age, Categorical(Participants) | Intravenous Kisspeptin | Subcutaneous Kisspeptin | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 15 | 36 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Intravenous Kisspeptin | Subcutaneous Kisspeptin | Total |
|---|---|---|---|
| Mean | 29.3 ± 8.3 | 30.4 ± 8.4 | 29.8 ± 8.2 |
| Sex: Female, Male(Participants) | Intravenous Kisspeptin | Subcutaneous Kisspeptin | Total |
|---|---|---|---|
| Female | 21 | 15 | 36 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Intravenous Kisspeptin | Subcutaneous Kisspeptin | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 2 | 11 |
| Not Hispanic or Latino | 10 | 9 | 19 |
| Unknown or Not Reported | 2 | 4 | 6 |
| Race (NIH/OMB)(Participants) | Intravenous Kisspeptin | Subcutaneous Kisspeptin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 9 | 7 | 16 |
| More than one race | 2 | 2 | 4 |
| Unknown or Not Reported | 6 | 3 | 9 |
| Region of Enrollment(participants) | Intravenous Kisspeptin | Subcutaneous Kisspeptin | Total |
|---|---|---|---|
| United States | 21 | 15 | 36 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — After primary results are published, the authors will provide individual participant data upon request as long as it does not conflict with state or institutional regulations
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gonadotropin-Releasing Hormone
Massachusetts General Hospital →