Effects of Glucagon-Like Peptide-1 Analogs on Sexuality (DESIRE)

University Hospital Basel

Status and phase: Completed; Phase 2

Conditions: Sexual Functioning

Treatments: Drug: Dulaglutide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04687514

2020-02572 me20ChristCrain3;

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 26 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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26 participants in 2 patient groups

Phase a (V1a-Ev2a): Dulaglutide first- Phase b (V1b-Ev2b) Placebo second

Experimental group

Description:

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.

Treatment:

Drug: Dulaglutide

Drug: Placebo

Phase a (V1a-Ev2a): Placebo first- Phase b (V1b-Ev2b) Dulaglutide second

Experimental group

Description:

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.

Treatment:

Drug: Dulaglutide

Drug: Placebo