Effects of Glucagon-Like Peptide-1 Analogs on Sexuality
- Sponsor
- University Hospital, Basel, Switzerland
- Study ID
- NCT04687514
- Phase
- PHASE2
- Status
- Completed
Conditions
- Sexual Functioning
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Accepted
Interventions
- Dulaglutide — DRUGDulaglutide: 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 — DRUGPlacebo: 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.
Study Details
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.
Key Dates
- Start date
- May 5, 2021
- Status verified
- Sep 2022
- Primary completion
- Sep 5, 2022
- Completion
- Sep 5, 2022
Study Design
- Enrollment
- 26 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Phase a (V1a-Ev2a): Dulaglutide first- Phase b (V1b-Ev2b) Placebo secondDulaglutide 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.
- Experimental: Phase a (V1a-Ev2a): Placebo first- Phase b (V1b-Ev2b) Dulaglutide secondThe 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.
Primary Outcome Measure
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. ]