Effects of Glucagon-Like Peptide-1 Analogs on Sexuality

NCT04687514 | Completed Phase 2

• 1 other identifier: 2020-02572; me20ChristCrain3
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Functioning

Keywords

dulaglutide; Glucagon-like peptide-1 (GLP-1) analogs; Massachusetts General Hospital - Sexual Functioning Questionnaire (MGH-SFQ); GLP-1 receptor

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (4)

• 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.

• Change in hormones of the reproductive axis

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

• Change in semen concentration

  at baseline and eight weeks after end of treatment

• Change in semen motility

  at baseline and eight weeks after end of treatment

Other Outcomes (5)

• Change in weight (kg)

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

• Change in BMI

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

• Change in HbA1c

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

Study Arms (2)

Phase a (V1a-Ev2a): Dulaglutide first- Phase b (V1b-Ev2b) Placebo second

EXPERIMENTAL

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; Drug: Placebo

Phase a (V1a-Ev2a): Placebo first- Phase b (V1b-Ev2b) Dulaglutide second

EXPERIMENTAL

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; Drug: Placebo

Interventions

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.

Phase a (V1a-Ev2a): Dulaglutide first- Phase b (V1b-Ev2b) Placebo second; Phase a (V1a-Ev2a): Placebo first- Phase b (V1b-Ev2b) Dulaglutide second

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.

Phase a (V1a-Ev2a): Dulaglutide first- Phase b (V1b-Ev2b) Placebo second; Phase a (V1a-Ev2a): Placebo first- Phase b (V1b-Ev2b) Dulaglutide second

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss National Science Foundation: collaborator
• Goldschmidt-Jacobson Foundation: collaborator

Study Sites (1)

University Hospital Basel, Endocrinology, Diabetes and Metabolism

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

dulaglutide

Study Officials

• Bettina Winzeler, Dr. med.

  Endocrinology, Diabetes and Metabolism, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants, health-care providers and data collectors are blinded to treatment allocation. Excluded from the blinding are defined study nurses administrating the injections as injection devices (dulaglutide/ placebo) are not identical. The unblinded study nurses are otherwise not involved in the trial. During the injection participants are blindfolded such as the injection device and the injection site is not visible for them.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo-controlled trial with crossover design: Dulaglutide or placebo weekly subcutaneously for 4 weeks; in random order, separated by washout period of at minimum 28 days.

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 29, 2020
• Study Start: May 5, 2021
• Primary Completion: September 5, 2022
• Study Completion: September 5, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

CH (1)