Effects of Glucagon-Like Peptide-1 Analogs on Sexuality

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Sexual Functioning

Intervention / Treatment
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* Drug: Dulaglutide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase a (V1a-Ev2a): Dulaglutide first- Phase b (V1b-Ev2b) Placebo second<br>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. | Drug: Dulaglutide<br>* Dulaglutide: first week 1x 1.5mg in 0.5 ml, following 3 weeks 2 x 1.5 mg weekly in 0.5ml each, via Pen s.c.<br>Drug: Placebo<br>* Placebo: first week 1x0.5 ml physiological saline (0.9% sodium chloride) injection s.c. via syringe, following weeks 2x0.5 ml physiological saline (0.9% sodium chloride) injection s.c. via syringe once weekly for 3 further weeks.<br>|
| Experimental: Phase a (V1a-Ev2a): Placebo first- Phase b (V1b-Ev2b) Dulaglutide second<br>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. | Drug: Dulaglutide<br>* Dulaglutide: first week 1x 1.5mg in 0.5 ml, following 3 weeks 2 x 1.5 mg weekly in 0.5ml each, via Pen s.c.<br>Drug: Placebo<br>* Placebo: first week 1x0.5 ml physiological saline (0.9% sodium chloride) injection s.c. via syringe, following weeks 2x0.5 ml physiological saline (0.9% sodium chloride) injection s.c. via syringe once weekly for 3 further weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sexual functioning, assessed with the German version of the Massachusetts General Hospital - Sexual Functioning Questionnaire (MGH-SFQ). | 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. | at baseline (before start of treatment) and after each week of treatment (V1, V2, V3, V4 and EV1), up to 10 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood changes, assessed by the German Version of the Patient Health Questionnaire-9 for Depression (PHQ-9) | Mood changes, assessed by the German Version of the Patient Health Questionnaire-9 for Depression (PHQ-9). . Each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). | at baseline and after end of treatment (V1 and EV1), up to 10 weeks. | 
| Change in hormones of the reproductive axis | Change in hormones of the reproductive axis (total testosterone (measured), free testosterone (derived from total testosterone), luteinizing hormone (LH), follicle stimulating hormone (FSH), sex hormone binding globulin (SHBG), prolactin and oxytocin.) | at baseline and after end of treatment (V1 and EV1), up to 10 weeks. | 
| Change in semen concentration | Change in semen concentration | at baseline and eight weeks after end of treatment | 
| Change in semen motility | Change in semen motility | at baseline and eight weeks after end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dulaglutide, GLP-1 receptor, Glucagon-like peptide-1 (GLP-1) analogs, Massachusetts General Hospital - Sexual Functioning Questionnaire (MGH-SFQ)