Effects of Glucagon-Like Peptide-1 Analogs on Sexuality - a Randomized, Double-blind, Placebo-controlled Trial With Crossover Design
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in sexual functioning, assessed with the German version of the Massachusetts General Hospital - Sexual Functioning Questionnaire (MGH-SFQ).
研究概览
简要总结
This placebo-controlled, double-blind crossover study is to evaluate the GLP-1 analogue dulaglutide regarding changes in sexuality, the mood and the reproductive axis in healthy men.
详细描述
This placebo-controlled, double-blind crossover study is to evaluate the GLP-1 analogue dulaglutide regarding changes in sexuality, the mood and the reproductive axis in healthy men.
The study consists of following two phases:
- Phase a (V1a-Ev2a): baseline evaluation (V1a), application of the trial medication (dulaglutide or placebo) during 4 weeks (V1a-V4a), evaluation of the primary and secondary outcomes (V2a-V4a, Ev1a), followed by a washout period of at minimum 28 days before evaluation of the last secondary outcome (Ev2a) and cross-over
- Phase b (V1b-Ev2b): baseline evaluation (V1b), application of the trial medication (dulaglutide or placebo) during further 4 weeks (V1b-V4b), evaluation of the primary and secondary outcomes (V2b-V4b, Ev1b), followed by a washout period of at minimum 28 days before evaluation of the last secondary outcome (Ev2b) and study end after study termination visit (STV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants, health-care providers and data collectors are blinded to treatment allocation. Excluded from the blinding are defined study nurses administrating the injections as injection devices (dulaglutide/ placebo) are not identical. The unblinded study nurses are otherwise not involved in the trial. During the injection participants are blindfolded such as the injection device and the injection site is not visible for them.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men with normal weight (BMI 18.5-25kg/m2 or BMI 25.1-30kg/m2 and waist circumference <102cm)
- •Written informed consent
- •Active sex life (sex with partner or masturbation ≥2x/week)
- •Satisfactory sex life
- •No Hypogonadism (morning total testosterone ≥12mmol/l)
排除标准
- •History of pancreatitis
- •History of psychiatric disease (by questioning the participant, also regarding current psychiatric treatment)
- •Daily nicotine abuse
- •Alcohol consumption (>1 glass/day)
- •Substance abuse (as eg cannabis, anabolic steroids, benzodiazepines, opiates, psychostimulants)
- •Regular intake of medication at any time
研究组 & 干预措施
Phase a (V1a-Ev2a): Dulaglutide first- Phase b (V1b-Ev2b) Placebo second
Dulaglutide is injected via pen s.c. once a week. The titration scale will be 1x 1.5mg in 0.5 ml in the first week and 2x 1.5 mg in 2x 0.5 ml once weekly for 3 further weeks. Dulaglutide or placebo weekly subcutaneously for 4 weeks; in random order, separated by washout period of at minimum 28 days.
干预措施: Dulaglutide (Drug)
Phase a (V1a-Ev2a): Dulaglutide first- Phase b (V1b-Ev2b) Placebo second
Dulaglutide is injected via pen s.c. once a week. The titration scale will be 1x 1.5mg in 0.5 ml in the first week and 2x 1.5 mg in 2x 0.5 ml once weekly for 3 further weeks. Dulaglutide or placebo weekly subcutaneously for 4 weeks; in random order, separated by washout period of at minimum 28 days.
干预措施: Placebo (Drug)
Phase a (V1a-Ev2a): Placebo first- Phase b (V1b-Ev2b) Dulaglutide second
The Placebo will be injected via syringe and contains 0.5ml (only first injection) or 2x0.5ml (second to fourth injection) of 0.9% sodium chloride (0.9% NaCl). Dulaglutide or placebo weekly subcutaneously for 4 weeks; in random order, separated by washout period of at minimum 28 days.
干预措施: Dulaglutide (Drug)
Phase a (V1a-Ev2a): Placebo first- Phase b (V1b-Ev2b) Dulaglutide second
The Placebo will be injected via syringe and contains 0.5ml (only first injection) or 2x0.5ml (second to fourth injection) of 0.9% sodium chloride (0.9% NaCl). Dulaglutide or placebo weekly subcutaneously for 4 weeks; in random order, separated by washout period of at minimum 28 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in sexual functioning, assessed with the German version of the Massachusetts General Hospital - Sexual Functioning Questionnaire (MGH-SFQ).
时间窗: at baseline (before start of treatment) and after each week of treatment (V1, V2, V3, V4 and EV1), up to 10 weeks.
Change in sexual functioning, assessed with the German version of the Massachusetts General Hospital - Sexual Functioning Questionnaire (MGH-SFQ). The MGH-SFQ consists of five items addressing libido, arousal, orgasm, erection, overall sexual satisfaction. Each item is rated by a discrete score ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 4 = moderately diminished; 5 = markedly diminished; 6 = totally absent). The MGH-SFQ sum score ranges from 5 to 30, with 10 indicating normal functioning, values \< 10 indicating improved functioning, and values \> 10 indicating diminished functioning. The primary endpoint is the absolute change from baseline to end of treatment in the MGH-SFQ sum score. A positive score change indicates worsening of sexual functioning. The primary endpoint will be compared for a difference between verum and placebo.
次要结局
- Mood changes, assessed by the German Version of the Patient Health Questionnaire-9 for Depression (PHQ-9)(at baseline and after end of treatment (V1 and EV1), up to 10 weeks.)
- Change in hormones of the reproductive axis(at baseline and after end of treatment (V1 and EV1), up to 10 weeks.)
- Change in semen concentration(at baseline and eight weeks after end of treatment)
- Change in semen motility(at baseline and eight weeks after end of treatment)