DESIRE: Effects of Glucagon-Like Peptide-1 Analogs on Sexuality

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT04687514

Collaborator

Swiss National Science Foundation (Other), Goldschmidt-Jacobson Foundation (Other)

Enrollment

Location

Arms

16.9

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

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
Sexual Functioning	Drug: Dulaglutide Drug: Placebo	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:

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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.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.

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

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.

Primary Purpose:

Basic Science

Official Title:

Effects of Glucagon-Like Peptide-1 Analogs on Sexuality - a Randomized, Double-blind, Placebo-controlled Trial With Crossover Design

Actual Study Start Date :

May 5, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Arm

Intervention/Treatment

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.

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

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

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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.

Responsible Party:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT04687514

Other Study ID Numbers:

2020-02572; me20ChristCrain3

First Posted:

Dec 29, 2020

Last Update Posted:

Mar 4, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Basel, Switzerland

dulaglutide

Glucagon-like peptide-1 (GLP-1) analogs

Massachusetts General Hospital - Sexual Functioning Questionnaire (MGH-SFQ)

GLP-1 receptor

Additional relevant MeSH terms:

Dulaglutide

Study Results

No Results Posted as of Mar 4, 2022