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

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.

Study Overview

• Status: Completed
• Conditions: Sexual Functioning
• Intervention / Treatment: Drug: Dulaglutide; Drug: Placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel, Endocrinology, Diabetes and Metabolism

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Dulaglutide; 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.; Drug: Placebo; 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.
EXPERIMENTAL: 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.	Drug: Dulaglutide; 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.; Drug: Placebo; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight (kg)	Change in weight (kg)	at baseline and after end of treatment (V1 and EV1), up to 10 weeks.
Change in BMI	Change in BMI	at baseline and after end of treatment (V1 and EV1), up to 10 weeks.
Change in HbA1c	Change in HbA1c	at baseline and after end of treatment (V1 and EV1), up to 10 weeks.
Change in serum glucose	Change in serum glucose	at baseline and after end of treatment (V1 and EV1), up to 10 weeks.
Change in adverse event (AE)-survey	Change in AE-survey (following symptoms will be assessed: abdominal pain, nausea, vomitus, diarrhoea, local irritation or pain, allergic reaction, fatigue, light-headedness)	at Visit 2, Visit 3, Visit 4 and Evaluation Visit (up to 4 weeks)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Swiss National Science Foundation; Goldschmidt-Jacobson Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 5, 2021
• Primary Completion (ACTUAL): September 5, 2022
• Study Completion (ACTUAL): September 5, 2022

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 27, 2020
• First Posted (ACTUAL): December 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Glucagon-like peptide-1 (GLP-1) analogs; GLP-1 receptor; dulaglutide; Massachusetts General Hospital - Sexual Functioning Questionnaire (MGH-SFQ)
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Dulaglutide
• Other Study ID Numbers: 2020-02572; me20ChristCrain3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No