Hyperprolactinemia, Hypogonadism
Conditions
Keywords
Kisspeptin, Hyperprolactinemia, GnRH, Hypogonadism
Brief 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.
Interventions
0.313 ug/kg - 2 ug/kg IV or SC
DRUGGnRH
0.075 ug/kg IV
Sponsors
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Inclusion/
Exclusion criteria
* confirmed diagnosis of elevated levels of prolactin measured via blood test, * no pituitary adenoma OR a microprolactinoma (\<10 mm). Patients with a macroprolactinoma confirmed on MRI imaging will be excluded, * no history of a medication reaction requiring emergency medical care, * no illicit drug use or excessive alcohol consumption (\>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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours | Up to 14 days | Average change in LH pulse frequency at baseline and during kisspeptin IV administration |
| Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin | Evaluated over eight days | Ultrasound evidence of increased follicle size over the course of SC kisspeptin administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Change in LH Pulse Amplitude | Up to 14 days | Average change in LH pulse amplitude at baseline and during IV kisspeptin administration |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravenous Kisspeptin 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). | 21 |
| Subcutaneous Kisspeptin Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days. | 15 |
| Total | 36 |
Baseline characteristics
| Characteristic | Intravenous Kisspeptin | Subcutaneous Kisspeptin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 15 Participants | 36 Participants |
| Age, Continuous | 29.3 years STANDARD_DEVIATION 8.3 | 30.4 years STANDARD_DEVIATION 8.4 | 29.8 years STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 2 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 9 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) White | 9 Participants | 7 Participants | 16 Participants |
| Region of Enrollment United States | 21 participants | 15 participants | 36 participants |
| Sex: Female, Male Female | 21 Participants | 15 Participants | 36 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 15 |
| other Total, other adverse events | 10 / 21 | 4 / 15 |
| serious Total, serious adverse events | 0 / 21 | 0 / 15 |
Outcome results
Primary
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
Population: No analysis of this outcome was performed for the Subcutaneous Kisspeptin Arm. These individuals did not undergo IV kisspeptin delivery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Kisspeptin | Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours | 3.000 pulses per 10 hour period | Standard Deviation 3.066 |
Primary
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
Population: No analysis of this outcome was performed for the Intravenous Kisspeptin Arm. These individuals did not undergo SC kisspeptin delivery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Kisspeptin | Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin | 3 Participants |
Secondary
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
Population: No analysis of this outcome was performed for the Subcutaneous Kisspeptin Arm. These individuals did not undergo IV kisspeptin delivery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Kisspeptin | Average Change in LH Pulse Amplitude | -0.5764 mIU/mL | Standard Deviation 8.061 |