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Phase 2 Kp-10 in Patients with Hypogonadotropic Hypogonadism

Award Number: R01FD007843
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2023
PERIOD OF PERFORMANCE END DATE: 05/31/2028

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Phase 2 Kp-10 in Patients with Hypogonadotropic Hypogonadism - PROJECT ABSTRACT Patients with idiopathic hypogonadotropic hypogonadism (IHH) have insufficient GnRH secretion. The lack of endogenous GnRH leads to absent LH and FSH, resulting in suppression of ovarian and testicular function and decreased levels of estradiol and testosterone. The neuropeptide kisspeptin is a powerful stimulus for GnRH induced LH secretion. The goal of this study is to explore the effects of pulsatile kisspeptin to stimulate the hypothalamic GnRH neurons of patients with HH. Thus, this application, if funded, can facilitate the translation of this therapeutic potential to the clinic.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $325,001 )
2026	2026	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Food and Drug Administration Research	000	2	6/16/2026	SUPPLEMENT FOR EXPANSION	$325,001
														Subtotal = $325,001

Issue Date FY: 2025 ( Subtotal = $324,996 )
2025	2025	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Food and Drug Administration Research	001	2	9/2/2025	NON-COMPETING CONTINUATION	$324,996
2025	2023	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Food and Drug Administration Research	000	1	3/21/2025	NEW	$0
														Subtotal = $324,996

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Food and Drug Administration Research	000	1	10/16/2023	NEW	$0
2024	2023	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Food and Drug Administration Research	001	1	5/8/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $649,997 )
2023	2023	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Food and Drug Administration Research	000	1	9/18/2023	NEW	$649,997
														Subtotal = $649,997

Grand Total All Awards = $1,299,994

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Phase 2 Kp-10 in Patients with Hypogonadotropic Hypogonadism

Award Number: R01FD007843

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/15/2023

PERIOD OF PERFORMANCE END DATE: 05/31/2028

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