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| ID | Type | Description | Link |
|---|---|---|---|
| FD-R-5712 | Other Grant/Funding Number | FDA Office of Orphan Products Development |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Kisspeptin | Experimental | 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). |
|
| Subcutaneous Kisspeptin | Experimental | Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kisspeptin 112-121 | Drug | 0.313 ug/kg - 2 ug/kg IV or SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Evaluated over eight days |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change in LH Pulse Amplitude | Average change in LH pulse amplitude at baseline and during IV kisspeptin administration | Up to 14 days |
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Inclusion/Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Seminara, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | Subcutaneous Kisspeptin | Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Subcutaneous Kisspeptin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | No analysis of this outcome was performed for the Subcutaneous Kisspeptin Arm. These individuals did not undergo IV kisspeptin delivery. | Posted | Mean | Standard Deviation | pulses per 10 hour period | Up to 14 days |
|
From the time of documented informed consent until completion of study procedures (an average of 3 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephanie Seminara | Massachusetts General Hospital | 617-724-5390 | MGHKisspeptinResearch@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2023 | Jun 28, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 30, 2020 | Jun 28, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006966 | Hyperprolactinemia |
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| GnRH | Drug | 0.075 ug/kg IV |
|
|
Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days.
|
|
| 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 | No analysis of this outcome was performed for the Intravenous Kisspeptin Arm. These individuals did not undergo SC kisspeptin delivery. | Posted | Count of Participants | Participants | Evaluated over eight days |
|
|
|
| Secondary | Average Change in LH Pulse Amplitude | Average change in LH pulse amplitude at baseline and during IV kisspeptin administration | No analysis of this outcome was performed for the Subcutaneous Kisspeptin Arm. These individuals did not undergo IV kisspeptin delivery. | Posted | Mean | Standard Deviation | mIU/mL | Up to 14 days |
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| 0 |
| 21 |
| 0 |
| 21 |
| 10 |
| 21 |
| EG001 | Subcutaneous Kisspeptin | Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days. | 0 | 15 | 0 | 15 | 4 | 15 |
| Fatigue | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Muscle Cramp | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |