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Sexual DesireDesire PLUSNCT05598008

Effects of Glucagon-like-Peptide-1 Analogues on Sexuality

An observational study of Sexual Desire, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to investigate the effects of GLP-1 analogues (combined with lifestyle interventions in comparison to lifestyle interventions only) on sexual desire, mood, quality of life, the reproductive axis, retinal vessel diameters, physical fitness (and semen, for men only) in overweight or obese men and women. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Sexual Desire
How many people
85 participants
Where
1 siteSwitzerland
Study dates
25 Nov 2022to 24 Oct 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population will consist of overweight men and women (BMI ≥ 27 kg/m2), which are seen at the obesity clinic of the University Hospital Basel and who wish to lose weight by lifestyle changes and optionally in combination with liraglutide treatment.

Who may be able to join

  • BMI ≥ 27 kg/m2
  • Willingness to lose weight by lifestyle changes only or by lifestyle changes plus GLP-1 analogue treatment as agreed in a routine clinical appointment
  • Active sex life (sex with partner or masturbation ≥2x/month)
  • Eugonadism:
  • Men: morning total testosterone ≥12mmol/l or free testosterone ≥ 0.198 nmol/l if< 50 years old and ≥ 0.163 if > 50 years old
  • Women: no primary or secondary amenorrhea (inclusive menopause) *Secondary amenorrhea is defined as "absence of menses for more than three months in women who previously had regular menstrual cycles or six months in women who had irregular menses".

Who cannot join

  • Diabetes mellitus, HbA1c ≥ 6,5 %
  • Previous use of GLP-1 analogues during last 2 months.
  • Exogenous testosterone substitution
  • Current illicit drug abuse
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Hospital Basel, Endocrinology, Diabetes and Metabolism

    Basel, 4031

Other trials in Switzerland

About this study

Official title: The Desire PLUS Study - Effects of Glucagon-like-Peptide-1 Analogues on Sexuality: a Prospective Open-label Study

This study is to investigate the effects of GLP-1 analogues (combined with lifestyle interventions in comparison to lifestyle interventions only) on sexual desire, mood, quality of life, the reproductive axis, retinal vessel diameters, physical fitness (and semen, for men only) in overweight or obese men and women.

Read the detailed description

Glucagon-like peptide-1 (GLP-1) analogues are widely used for the treatment of type 2 diabetes mellitus due to its well-known insulinotropic effects as well as for the treatment of obesity due to its satiation-promoting and appetite- suppressant effects. The GLP-1 analogues are approved in patients with obesity (BMI ≥ 30 kg/m2) or who are overweight (BMI ≥ 27 kg/m2) with additional comorbidities, such as prediabetes, diabetes mellitus type 2, arterial hypertension or dyslipidemia. Beside its influence on the reward for palatable food, several studies have shown that GLP-1 analogues modulate the rewarding effects of addictive drugs such as alcohol, nicotine and cocaine. As a further natural reward, sexual desire could be affected by GLP-1 analogues likewise.

This study investigates the influence of GLP-1 analogues on sexuality in a population of overweight and obese participants. A treatment with a GLP-1 analogue combined with lifestyle modifications for weight reduction will be compared to weight reduction with conventional lifestyle modifications only. In the context of the increasing use of GLP-1 analogues, particularly in young people with reproductive desire, laboratory analyzes of the reproductive axis (hormones and sperm cells) will be part of this study to document a possible influence. Mood changes, physical activity and fitness and effects on microvascular endothelial functioning by measuring diameters of retinal vessels will be further investigated.

Conditions
Sexual Desire
Keywords
Glucagon-like-Peptide-1 (GLP-1), Glucagon-like peptide-1 (GLP-1) analogues, obesity, sexuality, Liraglutide (Saxenda®), obese men, reproductive axis, microvascular endothelial function, retinal vessels, physical activity, physical fitness, mood, sperm cells
Medical subject headings
Obesity, Sexuality, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05598008
Study groupRoleWhat they receive
GLP-1 GroupGLP-1 Group: receiving GLP-1 analogues for weight management in addition to conventional weight management (= lifestyle intervention plus GLP-1 analogues). Conventional weight management is conducted according to clinical guidelines (in both groups) and includes nutritional and exercise counselling, counselling by motivational coaches and/ or psychological support. Participants in the GLP-1 group will inject the medication themselves.
Lifestyle groupLifestyle group: using conventional weight management (= lifestyle intervention only). Conventional weight management is conducted according to clinical guidelines (in both groups) and includes nutritional and exercise counselling, counselling by motivational coaches and/ or psychological support.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the German short version of the Sexual Desire Inventory (SDI-2) total score to assess sexual functioning

    The SDI-2 consists of two items addressing frequency of sexual thoughts or activity, rated by a discrete score ranging from 0 to 7 (0 = not at all; 1 = once a month; 2 = once in two weeks; 3 = once a week; 4 = twice a week; 5 = three to four times a week; 6 = once a day; 7 = several times a day), and eight items rating the strengths of different types of sexual desires, rated by a continuous score ranging from 0 to 8 (0 = no desire to 8 = strong desire). The SDI-2 sum score ranges from 0 to 78. A positive score change indicates improvement of sexual desire.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

Secondary outcomes (25)
  1. Change in the International Index of Erectile Function (IIEF-5) for men or Female Sexual Function Index (FSFI) for women questionnaire to assess sexual health and erectile function

    The IIEF-5 is a 15-item self-evaluation scale; it provides pre-post treatment clinic evaluations of erectile function, orgasmic function, sexual desire, satisfaction in sexual intercourse and general satisfaction.

    The FSFI is a 19-item self-reporting questionnaire; it measures dimensions such as desire, arousal, lubrication, orgasm, satisfaction, and pain during sexual activity.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  2. Change in the Patient Health Questionnaire (PHQ) -9 questionnaire to assess mood changes

    The PHQ-9 tool may reflect patients' accounts of their experiences of depression and to assess severity of and treatment response. Each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day).

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  3. Change in the Patient Health Questionnaire (EQ-5D-5L) questionnaire to assess quality of life

    The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems', and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression). The second part of the questionnaire comprises a standard vertical 20-cm VAS that is calibrated from 'the worst health you can imagine' (scored 0) at its base to 'the best health you can imagine' (scored 100) at its apex.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  4. Change in retinal vessel diameters to assess microvascular endothelial functioning

    Change in retinal vessel diameters with the Static Retinal Vessel Analyzer (SVA-T, Imedos Systems UG, Jena, Germany). The system consists of a fundus camera (Topcon TRC NW8) and analyzing software (Visualis 3.2, Imedos Systems UG), allowing non-invasive and non-mydriatic assessment of retinal vessel diameters.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  5. Change in Oxytocin Level (IU) (hormone of the reproductive axis)

    Oxytocin Level (hormone of the reproductive axis) will be measured in the blood.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  6. Change in semen concentration

    Change in semen concentration

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  7. Change in peak oxygen consumption during spiroergometry to assess physical fitness

    Change in peak oxygen consumption during spiroergometry

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  8. Change in maximum heart rate during spiroergometry

    Change in maximum heart rate during spiroergometry

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  9. Change in the Freiburg questionnaire for physical activity (FQPA)

    The questionnaire consists of 12 items and allows a calculation of weighted metabolic equivalent tasks (MET) hours per week. The Physical Activity Questionnaire (FPAQ) is used to measure physical activity. Individuals are considered physically active when they achieved metabolic equivalent tasks (MET) minutes of 600 or more per week.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  10. Change in Testosterone level (nmol/l) (hormone of the reproductive axis)

    Testosterone level (hormone of the reproductive axis) will be measured in the blood.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  11. Change in Estradiol level (pmol/l) (hormone of the reproductive axis)

    Estradiol level (hormone of the reproductive axis) will be measured in the blood.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  12. Change in Sex hormone-binding globulin (SHBG) level (nmol/l) (hormone of the reproductive axis)

    Sex hormone-binding globulin (SHBG) level (hormone of the reproductive axis) will be measured in the blood.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  13. Change in Luteinising hormone (LH) level (U/l) (hormone of the reproductive axis)

    Luteinising hormone (LH) level (hormone of the reproductive axis) will be measured in the blood.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  14. Change in Follicle stimulating hormone (LH) level (U/l) (hormone of the reproductive axis)

    Follicle stimulating hormone level (hormone of the reproductive axis) will be measured in the blood.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  15. Change in Prolactin level (yg/l) (hormone of the reproductive axis)

    Prolactin level (hormone of the reproductive axis) will be measured in the blood immediately (10-20 min) after ejaculation.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  16. Change in semen motility

    Change in semen motility

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  17. Change in sperm fragmentation index (percentage of sperm with fragmented DNA)

    Change in sperm fragmentation index (percentage of sperm with fragmented DNA)

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  18. Change in body weight (kg)

    Body weight is measured during the bioelectrical impedance analysis. The "InBody 720" device is used to perform the analysis.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  19. Change in body fat mass (%)

    Body fat mass is measured during the bioelectrical impedance analysis. The "InBody 720" device is used to perform the analysis.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  20. Change in total body water (l)

    Total body water is measured during the bioelectrical impedance analysis. The "InBody 720" device is used to perform the analysis.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  21. Change in extracellular water (%)

    Extracellular water is measured during the bioelectrical impedance analysis. The "InBody 720" device is used to perform the analysis.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  22. Change in intracellular water (%)

    Intracellular water is measured during the bioelectrical impedance analysis. The "InBody 720" device is used to perform the analysis.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  23. Change in hip/waist ratio

    Hip/waist ratio is measured during the bioelectrical impedance analysis. The "InBody 720" device is used to perform the analysis.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  24. Change in Basal metabolic rate ((kcal/24h)

    Basal metabolic rate is measured during the bioelectrical impedance analysis. The "InBody 720" device is used to perform the analysis.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

  25. Change in visceral fat (%)

    Visceral fat is measured during the bioelectrical impedance analysis. The "InBody 720" device is used to perform the analysis.

    Measured: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2022
  2. Study start25 Nov 2022
  3. Primary completion24 Oct 2025
  4. Study completion24 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05598008
Sponsor's protocol ID
2022-01367; kt22Winzeler
Acronym
Desire PLUS
Status last verified
Dec 2025
First submitted
19 Oct 2022
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sexual Desire, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the German short version of the Sexual Desire Inventory (SDI-2) total score to assess sexual functioning (time frame: At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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