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NCT Number: NCT04687514

Effects of Glucagon-Like Peptide-1 Analogs on Sexuality

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.

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Key information

Conditions

Sexual Functioning

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Basel, Endocrinology, Diabetes and Metabolism

Basel, 4031, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dulaglutide

Drug

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

Drug

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.

Primary outcomes

  1. Change in sexual functioning, assessed with the German version of the Massachusetts General Hospital - Sexual Functioning Questionnaire (MGH-SFQ).

    Time frame: at baseline (before start of treatment) and after each week of treatment (V1, V2, V3, V4 and EV1), up to 10 weeks.

    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.

Secondary outcomes

  1. Mood changes, assessed by the German Version of the Patient Health Questionnaire-9 for Depression (PHQ-9)

    Time frame: at baseline and after end of treatment (V1 and EV1), up to 10 weeks.

    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).

  2. Change in hormones of the reproductive axis

    Time frame: at baseline and after end of treatment (V1 and EV1), up to 10 weeks.

    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.)

  3. Change in semen concentration

    Time frame: at baseline and eight weeks after end of treatment

    Change in semen concentration

  4. Change in semen motility

    Time frame: at baseline and eight weeks after end of treatment

    Change in semen motility

Other outcomes

  1. Change in weight (kg)

    Time frame: at baseline and after end of treatment (V1 and EV1), up to 10 weeks.

    Change in weight (kg)

  2. Change in BMI

    Time frame: at baseline and after end of treatment (V1 and EV1), up to 10 weeks.

    Change in BMI

  3. Change in HbA1c

    Time frame: at baseline and after end of treatment (V1 and EV1), up to 10 weeks.

    Change in HbA1c

  4. Change in serum glucose

    Time frame: at baseline and after end of treatment (V1 and EV1), up to 10 weeks.

    Change in serum glucose

  5. Change in adverse event (AE)-survey

    Time frame: at Visit 2, Visit 3, Visit 4 and Evaluation Visit (up to 4 weeks)

    Change in AE-survey (following symptoms will be assessed: abdominal pain, nausea, vomitus, diarrhoea, local irritation or pain, allergic reaction, fatigue, light-headedness)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Goldschmidt-Jacobson Foundation
  • Swiss National Science Foundation

Registry information

Official study title

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

Acronym: DESIRE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2020
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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