Kisspeptin Administration Subcutaneously to Patients With IHH

Официальное название

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Обзор

The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time. Funding Source: FDA OOPD

Подробное описание

Assignment: All study subjects will undergo the same interventions.

Delivery of Interventions:

* Each subject will undergo a review of their medical history, physical exam, and screening laboratories. * A single SC injection of leuprolide acetate may be administered approximately six days before kisspeptin administration. (Previously administration of Gonadotropin Releasing Hormone (GnRH) was used in this study.) * A pelvic ultrasound will be performed on women to assess baseline follicular size. * A pump will be placed to administer pulsatile SC kisspeptin for two weeks. * During the course of kisspeptin administration, subjects will * Undergo q10 min blood sampling (approximately 10 sessions, 70 minutes each) * For women, undergo pelvic ultrasounds (approximately 4 sessions) * Optional q10 min sampling up to 8 hours may take place before and after the course of kisspeptin

Вмешательства

• Препарат kisspeptin 112-121
  SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes)
• Препарат leuprolide acetate
  Single SC bolus

Первичные конечные точки

• Average change in luteinizing hormone (LH) pulse amplitude [Срок оценки: 2 weeks]

Вторичные конечные точки (1)

• Percentage of female participants who demonstrate achievement of a mature follicle or show evidence of ovulation [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

• Congenital IHH
• Confirmed diagnosis by medical provider supported by low sex steroids in the setting of low or inappropriately normal gonadotropins
• Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
• No current or recent use of a medication that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and method of administration
• If applicable, willing to use birth control methods (as approved by a study medical professional) during the entire study and for one month after the last dose of study drug

Критерии исключения

• Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
• Excessive alcohol consumption (>10 drinks/week)
• Active use of illicit drugs (not including marijuana)
• For women:
• Pregnant or trying to become pregnant
• Breast feeding
• History of: bilateral oophorectomy (both ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT05896293 · FD007843

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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