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A randomized, open label balanced two period, two-treatment, two-sequence crossover study to evaluate the effect of food on the pharmacokinetics of buspirone after a single oral administration of Lybridos in healthy female subjects

Primary objective1. To determine the effect of food on the pharmacokinetics of buspirone administered as the Lybridos formulationSecondary objective1. To evaluate the safety and tolerability of a single dose of Lybridos under fasted and fed…

A double blind, randomized, placebo controlled, cross-over study to validate the predictive power of the demarcation formula for Lybrido and Lybridos efficacy in women with female sexual interest/arousal disorder, in the domestic situation.

Primary Objective• To validate the existing demarcation formula (consisting of psychometric and biological markers) which predicts the sensitivity to Lybrido or Lybridos in women with female sexual interest/arousal disorder (FSIAD with or without…

Phase 1-3 development of a questionnaire for assessing sexual health in cancer patients:
A cross cultural project of the EORTC Quality of Life Group

The aim of this project is to develop a comprehensive EORTC questionnaire for assessing sexual health for male and female patients with cancer. Given the lack of a sexual health related measure that can be used in clinical trials and in clinical…

A randomized, open label balanced two period, two-treatment, two-sequence crossover study to evaluate the effect of food on the pharmacokinetics of sildenafil after a single oral administration of Lybrido in healthy female subjects

Primary objective1. To determine the effect of food on the pharmacokinetics of sildenafil administered as the Lybrido formulation2. To determine whether >90% of the testosterone content is released after maximally 90 seconds after sublingual…

Central mechanisms of ejaculatory dysfunction: a multi-modal fMRI investigation

The aim of the proposed research is to assess, using multimodal fMRI, both functional (BOLD responses) and structural (white matter) cerebral characteristics of the human IELT. In turn, this could provide specific novel (neocortical) targets in the…

Sexual complaints in female cancer survivors: Is there a need for treatment?

Observational multicenter trialThe following research questions (Q) will be addressed in patients (and partners) (Q1) whether sexual problems as reported by female cancer survivors are personally distressing and if so, ( Q2) what are possible…

A double-blind, randomized, placebo-controlled, proof of concept study to investigate the safety and efficacy of the combined administration of 0.5 mg sublingual testosterone and 10 mg tadalafil in women with hypoactive sexual desire disorder

Primary ObjectiveTo investigate the possible efficacy of combined administration of 0.5 mg sublingual testosterone and 10 mg tadalafil in increasing sexual satisfaction during sexual activity in the domestic setting in healthy female subjects with…

Single-Center, Randomized Single-Blind Placebo-Controlled Five-Arm Parallel Group Study to Assess Efficacy of a Single Dose of TBS-2 Intranasal Gel at Four Time Points Post-Dose using Vibrotactile Stimulation combined with Visual Sexual Stimulation in Female Subjects with Primary and Secondary Anorgasmia

This clinical trial is being performed to evaluate the efficacy of a single dose of TBS-2 on the occurence of orgasm. This study will explore the effect of TBS-2 on inducing an orgasm following sexual stimuli in anorgasmic female subjects at four…

A randomised, double-blind, placebo-controlled, parallel group, single centre study investigating the brain processing of visual stimuli in pre-menopausal women with generalized acquired hypoactive sexual desire disorder after 8 weeks of flibanserin (100 mg) treatment.

Change from baseline in regional cerebral blood flow in response to various visual stimuli ascertained by Positron Emission Tomography scan after 8 weeks of flibanserin 100 mg treatment.

A double-blind, randomized, placebo-controlled, proof of concept study to investigate the differences between the combined administration of 0.5 mg sublingual testosterone and 10 mg buspirone and 10 mg buspirone administration alone in women with hypoactive sexual desire disorder

To investigate the differences between the combined administration of 0.5 mg sublingual testosterone and 10 mg buspirone and 10 mg buspirone administration alone in increasing sexual satisfaction during sexual activity in the domestic setting in…

A short CBT intervention for sexual rehabilitation among women receiving radiotherapy with gynecological cancer: A pilot study.

To investigate whether a short CBT intervention for sexual rehabilitation is feasible for patients (and their partners) and professionals. The available literature underscores the importance of sexual problems after pelvic RT and the need to develop…

The place of pelvic floor complaints and sexual abuse in the gastroenterology practice: a cross-sectional study in colonoscopy patients

The purpose of this study is to evaluate patients consulting gastroenterologists regarding their perspectives concerning delicate matters such as sexuality. Would it be helpful if the doctor brings up the subject of SA? And how many patients would…

Women*s experiences with vaginal dilator use following radiotherapy for gynaecological cancer: a qualitative study.

By investigating reasons for (non-)compliance with vaginal dilation in a sample of gynecological cancer patients receiving RT, we hope to identify facilitating and limiting factors relevant for the development of a sexual rehabilitation program.…

Two-Center, In-Patient, Randomized, Placebo and Active Comparator Evaluation of the Pharmacokinetics (PK) and Safety, Along with Initial Pharmacodynamic (PD) Efficacy of Three Dose Levels of TBS-2 Intranasal Gel Applied Twice-Daily (BID) for up to Three Days in Female Patients with Hypoactive Sexual Desire Disorder (HSDD) or Anorgasmia (ANOR).

This clinical trial is being performed to evaluate the PK profile of TBS-2 administered as single and multiple (BID) doses in patients with HSDD or ANOR. In addition, the study will evaluate the initial PD efficacy and safety of intranasal TBS-2 BID…

Pilot study: A comparison of the gold standard for measuring genital blood flow in humans with infrared thermal imaging as sex-neutral measurement

To compare the present gold standard for measuring genital blood flow in humans (for men: a mechanical penile strain gauge (Barlow-gauge) , for women: vaginal photoplethysmography) with infrared technology.

The psychosexual development of children with atypical gender role behaviour in childhood

The aim of the current study is to obtain a better understanding of the psychosexual outcome and development of children with atypical gender role behaviour.

A methodological investigation to test acute changes in female sexual desire in healthy volunteers and pre- and postmenopausal women diagnosed with hypoactive sexual desire disorders using explicit measures in a controlled laboratory setting and behavioral measures at home, in no-drug as well as placebo-controlled within subjects cross-over drug (a single dose of testosterone gel 50mg [1% in 5g] conditions.

In order to better understand sexual desire (e.g., fluctuations in desire, level of desire to distinct sexual stimuli varying in intensity, subtypes of desire disorder) it is important to examine methods for rapid detection of desire changes.…

The genetic basis of gender dysphoria

The purpose of the study is to identify genetic changes that cause gender dysphoria.

Inventory of sexual dysfunctions in patients with post-traumatic stress disorder (PTSD) and patients with obsessive compulsive disorder (OCD)

Primary objectives are to investigate (1) the prevalence and nature of sexual dysfunctions in patients meeting the criteria for PTSD or OCD, and; (2) whether sexual dysfunctions decreases after the guideline treatment aimed at PTSD or OCD. Secondary…

Transdermal Rigidity assessment via Ischemia (and temperature) of the Penis (TRIP) versus the Rigiscan. A new sensor-driven device to measure rigidity of the penis.

In men without erectile problems, night time erections occur during the REM-sleep. For this study we will compare the current diagnostic test, the Rigiscan, with the data from de TRIP-Patch during the night. To validate discriminating sensor-…