Effects of Glucagon-Like Peptide-1 Analogs on Sexuality

Sexual Functioning Clinical Trial

— DESIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04687514
• Other study ID #: 2020-02572; me20ChristCrain3
• Status: Completed
• Phase: Phase 2
• Start date: May 5, 2021
• Est. completion date: September 5, 2022

Study information

• Verified date: September 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 5, 2022
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Sexual Functioning

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Endocrinology, Diabetes and Metabolism	Basel

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Goldschmidt-Jacobson Foundation, Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in weight (kg)	Change in weight (kg)	at baseline and after end of treatment (V1 and EV1), up to 10 weeks.
Other	Change in BMI	Change in BMI	at baseline and after end of treatment (V1 and EV1), up to 10 weeks.
Other	Change in HbA1c	Change in HbA1c	at baseline and after end of treatment (V1 and EV1), up to 10 weeks.
Other	Change in serum glucose	Change in serum glucose	at baseline and after end of treatment (V1 and EV1), up to 10 weeks.
Other	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)
Primary	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	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.
Secondary	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.
Secondary	Change in semen concentration	Change in semen concentration	at baseline and eight weeks after end of treatment
Secondary	Change in semen motility	Change in semen motility	at baseline and eight weeks after end of treatment