Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
| Goldschmidt-Jacobson Foundation | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mood changes, assessed by the German Version of the Patient Health Questionnaire-9 for Depression (PHQ-9) | 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). | at baseline and after end of treatment (V1 and EV1), up to 10 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight (kg) | Change in weight (kg) | at baseline and after end of treatment (V1 and EV1), up to 10 weeks. |
| Change in BMI | Change in BMI |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bettina Winzeler, Dr. med. | Endocrinology, Diabetes and Metabolism, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel, Endocrinology, Diabetes and Metabolism | Basel | 4031 | Switzerland |
Not provided
| ID | Term |
|---|---|
| C555680 | dulaglutide |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
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.
| 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. |
|
| Change in hormones of the reproductive axis | 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.) | at baseline and after end of treatment (V1 and EV1), up to 10 weeks. |
| Change in semen concentration | Change in semen concentration | at baseline and eight weeks after end of treatment |
| Change in semen motility | Change in semen motility | at baseline and eight weeks after end of treatment |
| at baseline and after end of treatment (V1 and EV1), up to 10 weeks. |
| Change in HbA1c | Change in HbA1c | at baseline and after end of treatment (V1 and EV1), up to 10 weeks. |
| Change in serum glucose | Change in serum glucose | at baseline and after end of treatment (V1 and EV1), up to 10 weeks. |
| Change in adverse event (AE)-survey | Change in AE-survey (following symptoms will be assessed: abdominal pain, nausea, vomitus, diarrhoea, local irritation or pain, allergic reaction, fatigue, light-headedness) | at Visit 2, Visit 3, Visit 4 and Evaluation Visit (up to 4 weeks) |