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NCT04687514·Phase 2·INTERVENTIONAL

Effects of Glucagon-Like Peptide-1 Analogs on Sexuality

DulaglutideOtherCompleted

Status

Completed

Phase

Phase 2

Enrollment

26

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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: * 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).

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Dec 29, 2020

  2. Study start

    May 5, 2021

  3. Primary completion

    Sep 5, 2022

  4. Study completion

    Sep 5, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Sep 7, 2022

Outcomes

What the study measures.

Primary outcomes

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

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).

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.)

Change in semen concentration

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

Change in semen concentration

Change in semen motility

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

Change in semen motility

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
50 Years
Sex
MALE
Healthy volunteers
Yes

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

Study locations

1 registered sites.

Switzerland. Showing up to 24 locations stored in the fast local snapshot.

University Hospital Basel, Endocrinology, Diabetes and Metabolism

Basel, Switzerland

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Dulaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsDulaglutide trial dashboard →DatabaseDulaglutide database entry →ResearchDulaglutide research guide →