Effects of Glucagon-Like Peptide-1 Analogs on Sexuality

Effects of Glucagon-Like Peptide-1 Analogs on Sexuality - a Randomized, Double-blind, Placebo-controlled Trial With Crossover Design

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.

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).

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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