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The investigators are looking for subjects to complete a study on the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that tells the body to produce other reproductive hormones. However, giving someone a continued amount of kisspeptin over a period of time can have the opposite effect and tell the body to, for a short time, stop making hormones needed for reproduction. By giving 24-hour infusions of kisspeptin, the investigators hope to learn more about the role kisspeptin has in the way bodies function normally and the role it has in conditions that affect the reproductive system.
Please contact study staff for a detailed description.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| kisspeptin, GnRH | Experimental | 24-hour continuous intravenous infusion of kisspeptin 112-121 (12.5-40 mcg/kg/h), single intravenous dose of kisspeptin 112-121 (0.313-13.19 mcg/kg), and single bolus of GnRH (gonadotropin-releasing hormone) (2.5-250 ng/kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kisspeptin 112-121 | Drug | 24-h continuous intravenous infusion of kisspeptin 112-121 (12.5-40 mcg/kg/h), single intravenous dose of kisspeptin 112-121 (0.313-13.19 mcg/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average difference in Luteinizing Hormone (LH) concentration at the beginning and end of kisspeptin infusion | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Average difference in testosterone concentration at the beginning and end of kisspeptin infusion (males) | 24 hours | |
| Average difference in estradiol concentration at the beginning and end of kisspeptin infusion (females) | 24 hours |
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A. Healthy Subjects
All healthy subjects will meet the following criteria:
Additional criteria based on subject population:
Healthy Men:
Healthy women:
Healthy postmenopausal women:
B. Subjects with Reproductive Disorders
All subjects with reproductive disorders will meet the following criteria:
Additional criteria based on subject population:
Men and women with hypogonadotropic hypogonadism,
Agonadal men,
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie B Seminara, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42230485 | Derived | Naveed A, Lippincott MF, Stamou M, Balasubramanian R, Bryant NK, Seminara SB. Dynamic modulation of LH secretion by continuous kisspeptin infusion in healthy men. Hormones (Athens). 2026 Jun 2. doi: 10.1007/s42000-026-00795-y. Online ahead of print. | |
| 28368443 | Derived | Lippincott MF, Chan YM, Rivera Morales D, Seminara SB. Continuous Kisspeptin Administration in Postmenopausal Women: Impact of Estradiol on Luteinizing Hormone Secretion. J Clin Endocrinol Metab. 2017 Jun 1;102(6):2091-2099. doi: 10.1210/jc.2016-3952. |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D006059 | Gonadal Dysgenesis |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
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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 | Single intravenous dose of GnRH (2.5-250 ng/kg) |
|
|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| 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 |