DESIRE: Effects of Glucagon-Like Peptide-1 Analogs on Sexuality
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
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:
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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
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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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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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.
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Outcome Measures
Primary Outcome Measures
- Change in sexual functioning, assessed with the German version of the Massachusetts General Hospital - Sexual Functioning Questionnaire (MGH-SFQ). [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 Outcome Measures
- Mood changes, assessed by the German Version of the Patient Health Questionnaire-9 for Depression (PHQ-9) [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).
- Change in hormones of the reproductive axis [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.)
- Change in semen concentration [at baseline and eight weeks after end of treatment]
Change in semen concentration
- Change in semen motility [at baseline and eight weeks after end of treatment]
Change in semen motility
Other Outcome Measures
- Change in weight (kg) [at baseline and after end of treatment (V1 and EV1), up to 10 weeks.]
Change in weight (kg)
- Change in BMI [at baseline and after end of treatment (V1 and EV1), up to 10 weeks.]
Change in BMI
- Change in HbA1c [at baseline and after end of treatment (V1 and EV1), up to 10 weeks.]
Change in HbA1c
- Change in serum glucose [at baseline and after end of treatment (V1 and EV1), up to 10 weeks.]
Change in serum glucose
- Change in adverse event (AE)-survey [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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy men with normal weight (BMI 18.5-25kg/m2 or BMI 25.1-30kg/m2 and waist circumference <102cm)
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Written informed consent
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Active sex life (sex with partner or masturbation ≥2x/week)
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Satisfactory sex life
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No Hypogonadism (morning total testosterone ≥12mmol/l)
Exclusion Criteria:
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History of pancreatitis
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History of psychiatric disease (by questioning the participant, also regarding current psychiatric treatment)
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Daily nicotine abuse
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Alcohol consumption (>1 glass/day)
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Substance abuse (as eg cannabis, anabolic steroids, benzodiazepines, opiates, psychostimulants)
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Regular intake of medication at any time
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University Hospital Basel, Endocrinology, Diabetes and Metabolism | Basel | Switzerland | 4031 |
Sponsors and Collaborators
- University Hospital, Basel, Switzerland
- Swiss National Science Foundation
- Goldschmidt-Jacobson Foundation
Investigators
- Principal Investigator: Bettina Winzeler, Dr. med., Endocrinology, Diabetes and Metabolism, University Hospital Basel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-02572; me20ChristCrain3