Effects of Glucagon-Like Peptide-1 Analogs on Sexuality
NCT ID: NCT04687514
Last Updated: 2022-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2021-05-05
2022-09-05
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
50 Years
MALE
Yes
Sponsors
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Swiss National Science Foundation
OTHER
Goldschmidt-Jacobson Foundation
UNKNOWN
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Bettina Winzeler, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Endocrinology, Diabetes and Metabolism, University Hospital Basel
Locations
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University Hospital Basel, Endocrinology, Diabetes and Metabolism
Basel, , Switzerland
Countries
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Other Identifiers
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2020-02572; me20ChristCrain3
Identifier Type: -
Identifier Source: org_study_id
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