Clinical trial NCT04687514: Effects of Glucagon-Like Peptide-1 Analogs on Sexuality
Official title: Effects of Glucagon-Like Peptide-1 Analogs on Sexuality - a Randomized, Double-blind, Placebo-controlled Trial With Crossover Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sexual Functioning
Keywords: dulaglutide
Glucagon-like peptide-1 (GLP-1) analogs
Massachusetts General Hospital - Sexual Functioning Questionnaire (MGH-SFQ)
GLP-1 receptor
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Goldschmidt-Jacobson Foundation
First posted: 2020-12-29
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized, double-blind, placebo-controlled trial with crossover design: Dulaglutide or placebo weekly subcutaneously for 4 weeks; in random order, separated by washout period of at minimum 28 days.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in sexual functioning, assessed with the German version of the Massachusetts General Hospital - Sexual Functioning Questionnaire (MGH-SFQ).
timeFrame: at baseline (before start of treatment) and after each week of treatment (V1, V2, V3, V4 and EV1), up to 10 weeks.
Secondary outcomes:
measure: Mood changes, assessed by the German Version of the Patient Health Questionnaire-9 for Depression (PHQ-9)
timeFrame: at baseline and after end of treatment (V1 and EV1), up to 10 weeks.
measure: Change in hormones of the reproductive axis
timeFrame: at baseline and after end of treatment (V1 and EV1), up to 10 weeks.
measure: Change in semen concentration
timeFrame: at baseline and eight weeks after end of treatment
measure: Change in semen motility
timeFrame: at baseline and eight weeks after end of treatment
Other outcomes:
measure: Change in weight (kg)
timeFrame: at baseline and after end of treatment (V1 and EV1), up to 10 weeks.
measure: Change in BMI
timeFrame: at baseline and after end of treatment (V1 and EV1), up to 10 weeks.
measure: Change in HbA1c
timeFrame: at baseline and after end of treatment (V1 and EV1), up to 10 weeks.
measure: Change in serum glucose
timeFrame: at baseline and after end of treatment (V1 and EV1), up to 10 weeks.
measure: Change in adverse event (AE)-survey
timeFrame: at Visit 2, Visit 3, Visit 4 and Evaluation Visit (up to 4 weeks)
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Endocrinology, Diabetes and Metabolism
Study officials:
affiliation: Endocrinology, Diabetes and Metabolism, University Hospital Basel
name: Bettina Winzeler, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: