NCT05381831已完成4 期
The Effects of Intranasal Testosterone (NatestoTM) for Treatment of Hypogonadism on Maintenance of Spermatogenesis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Changes in total motile sperm count
研究概览
简要总结
This is a prospective, non-blinded study of hypogonadal men with a history of testosterone therapy who became azoospermic or severely oligospermic and wish to avoid symptoms of hypogonadism during their recovery of spermatogenesis in an effort to establish paternity. The study will determine if Natesto can alleviate hypogonadal symptoms while preserving the recovery of spermatogenesis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male between 18 and 64 years of age, with documented onset of testosterone induced hypogonadism with impaired semen parameters who are attempting to achieve a successful pregnancy.
- •Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
- •Serum total testosterone < 350 ng/dL based on 2 consecutive blood samples obtained 1-4 weeks apart between 6 and 10 AM following an appropriate washout of current androgen replacement therapy; with clinical symptoms of hypogonadism such as diminished energy and sexual function; and/or a decreased sperm count (<20 million sperm/mL semen).
- •Discontinued current testosterone replacement treatment and completed a washout of 4 weeks following androgen treatment (excluding Testopel TM). Washout must be completed prior to collection of baseline serum testosterone samples to determine study eligibility.
- •Judged to be in good general health as determined by the principal investigator based upon the results of a medical history, physical examination, vital signs, and laboratory profile.
排除标准
- •History of significant sensitivity or allergy to androgens, castor oil or product excipients.
- •Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up.
- •Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or I-PSS score greater than 19 points.
- •Body mass index (BMI) equal to or greater than or equal to 40 kg/m
- •History of vasectomy.
- •Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
- •Baseline hemoglobin greater than 16 g/dL
- •Hematocrit less than 35% or greater than 50%
- •PSA greater than 4 ng/mL and age greater than 40
- •History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
- •History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration.
- •History of stroke or myocardial infarction within the past 5 years.
- •History of, or current or suspected, prostate or breast cancer.
- •History of diagnosed, severe, untreated, obstructive sleep apnea.
- •History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
- •History of nasal disorders such as nasal polyps; nasal septal perforation; nasal surgery; nasal trauma resulting in nasal fracture within the previous 6 months or nasal fracture that caused a deviated anterior nasal septum; sinus surgery or sinus disease
- •Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 12 weeks prior to the start of treatment.
- •Inadequate venous access for collection of serial blood samples required for pharmacokinetic profiles.
- •Receipt of any investigational product within 4 weeks or within 5 half-lives prior to the start of treatment.
- •Inability to understand and provide written informed consent for the study.
- •Considered by the investigator or the sponsor-designated physician, for any reason, that the subject is an unsuitable candidate to receive Natesto.
研究组 & 干预措施
NatestoTM
Experimental
Participants in this group will receive Natesto for a 26 consecutive weeks treatment course
干预措施: NatestoTM (Drug)
结局指标
主要结局
Changes in total motile sperm count
时间窗: Baseline up to 26 weeks
Change in sperm count will be analyzed using the ANOVA. A change in \< ± 10% will be reject the null hypothesis.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Intranasal Delivery of Testosterone and Its Effect on Doping MarkersAbuse of Anabolic SteroidsNCT02611154University of Utah5
撤回
早期 1 期
The Effects of Natesto For Treatment Of HypogonadismHypogonadism, MaleInfertility, MaleTestosterone DeficiencyNCT04717362Baylor College of Medicine
招募中
不适用
Result of testosterone (name of drug)in liver diseaseCTRI/2019/08/021000Institute of Liver and Biliary Sciences
进行中（未招募）
1 期
Does Testposterone improve the Pain Perception of Patients with Chronic Pain?Patient with persistent somatoform pain disorder (F45.40 or F45.41) should be included into the study.EUCTR2016-000048-32-DERWTH Aachen University/CTC-A60
已完成
1 期
Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without DutasterideHypogonadismHypogonadism, MaleNCT00400335GlaxoSmithKline60