Study Results
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Basic Information
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COMPLETED
PHASE1
61 participants
INTERVENTIONAL
2014-04-30
2016-05-31
Brief Summary
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We hypothesize that naloxone, by blocking dynorphin, will stimulate production of gonadotropin-releasing hormone (GnRH) and kisspeptin, two other naturally occurring reproductive hormones.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Naloxone, Kisspeptin, GnRH
Intravenous (IV) administration of kisspeptin 112-121, GnRH, and naloxone
Kisspeptin 112-121
Subjects will receive up to 10 IV doses of kisspeptin 112-121
Naloxone
Subjects will receive one IV dose of naloxone followed by an IV infusion of naloxone.
GnRH
Subjects will receive up to 10 doses of IV GnRH
Interventions
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Kisspeptin 112-121
Subjects will receive up to 10 IV doses of kisspeptin 112-121
Naloxone
Subjects will receive one IV dose of naloxone followed by an IV infusion of naloxone.
GnRH
Subjects will receive up to 10 doses of IV GnRH
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal blood pressure (systolic BP \<140 mm Hg, diastolic BP \<90 mm Hg)
* White blood cell, platelets, prolactin, and thyroid stimulating hormone (TSH)within 90%-110% of laboratory reference range
* Negative urine drug screen panel
* Hemoglobin:
1. For healthy men and healthy regularly cycling women: normal
2. For men and women with HH: No less than 0.5 gm/dL below the lower limit of the reference range for normal women
* Blood urea nitrogen (BUN), creatinine, liver function tests not elevated
* For healthy subjects: Normal reproductive function and history
* For healthy subjects: Body Mass Index (BMI) 18.5-30kg/m2
* For subjects with HH: All medical conditions stable and well controlled
Exclusion Criteria
* Illicit drug use
* Consumption of more than 10 alcoholic drinks per week
* Difficulty with blood draws
* Currently seeking fertility, breastfeeding, or pregnant
* For healthy subjects: history of chronic disease and prescription medication use (with the exception of seasonal allergy medication)
* For subjects with HH: prescription medications known to affect reproductive endocrine function except for those used to treat the subject's reproductive condition
18 Years
75 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Stephanie B. Seminara, MD
Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine
Principal Investigators
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Stephanie B Seminara, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Lippincott MF, Leon S, Chan YM, Fergani C, Talbi R, Farooqi IS, Jones CM, Arlt W, Stewart SE, Cole TR, Terasawa E, Hall JE, Shaw ND, Navarro VM, Seminara SB. Hypothalamic Reproductive Endocrine Pulse Generator Activity Independent of Neurokinin B and Dynorphin Signaling. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4304-4318. doi: 10.1210/jc.2019-00146.
Chan YM, Lippincott MF, Kusa TO, Seminara SB. Divergent responses to kisspeptin in children with delayed puberty. JCI Insight. 2018 Apr 19;3(8):e99109. doi: 10.1172/jci.insight.99109. eCollection 2018 Apr 19.
Other Identifiers
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2013P001543
Identifier Type: -
Identifier Source: org_study_id
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