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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…

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 study of an internet-based cognitive behavioral therapy program for sexuality and intimacy problems in women treated for breast cancer.

The proposed study will evaluate the efficacy of an internet-based cognitive behavioral intervention program designed to alleviate sexuality and intimacy problemens of women who have been treated for breast cancer.

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…

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…

Sex hormones, sex chromosomes, and sexual differentiation of the brain

Our objective is to determine the role of androgens and the Y-chromosome in sexual differentiation of the brain. Women with CAIS, who only differ from typical women in that they have a Y-chromosome, and from men in that they cannot respond to…

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…

The effect of cognitive behavioral therapy on female sexual dysfunction:
A research that compares internet-based with face-to-face therapy

Objective of the study is to measure Cognitive Behavioral Therapy by means of internet compared to regular face-to-face therapy and waiting list at several types of sexual dysfunctions of women.

A randomized, cross-over controlled study to compare the pharmacokinetic profiles of sublingual administered testosterone solution followed by a sildenafil citrate tablet, versus sublingual testosterone and sildenafil citrate combined in one tablet in healthy premenopausal women

Primary objective:To compare the pharmacokinetics of testosterone and sildenafil citrate following administration of a sublingual solution of testosterone with an encapsulated tablet versus a combination product.Secondary objective:To investigate…

Effect of Inflammatory Bowel Disease on sexual function in men and women: A controlled study

The present study aims to extent the sparse knowledge on sexual function in IBD by 1) examining the prevalence of sexual problems in men and women with IBD (including Crohn*s disease and ulcerative colitis), 2) comparing this with the prevalence of…

A randomized, cross-over controlled study to compare the pharmacokinetic profiles of sublingual administered testosterone solution followed by a buspirone tablet, versus sublingual testosterone and buspirone combined in one tablet in healthy premenopausal women

To compare the pharmacokinetics of sublingual testosterone cyclodextrin followed by buspirone as an encapsulated tablet with administration of testosterone and buspirone as one tablet designed to release the components in a specific time-frame.

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…

Retraining automatic sexual actiontendencies in women with female sexual interest/arousal disorder

The aim of this study is to investigate whether women with FSDA and women without sexual problems can be trained with an AAT to perform more approach behaviour and less avoidance behaviour to sexual stimuli. The hypotheses which will be tested are (…

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.

Research into the efficacy and cost-effectiveness of short term, cost free and anonymous sex counselling to improve (mental) health (including development of protocol and training plan)

This project has three objectives:1. DevelopmentThe development objective is to prepare the implementation of this preventive intervention on the onehand by developing and accommodating protocols for sex counselling in the important fields of…

Sexual dysfunction and need for help voor sexual problems in patients with mental disorders

To answer the following questions: a. Do male and female patients receiving treatment or recently treated for mental problems experience more sexual dysfunction compared to an age-matched control group from the general population? b. What is the…

EMDR and exhibitionism: a randomized controlled trial on reducing deviant sexual arousal

A) To test if the EMDR addiction protocol by Hornsveld and Markus (2014), as an intervention, will lead to a reduction of deviant sexual arousal in exhibitionists, within four sessionsB) To test if the treatment effect is stableC) To test if the…

Reinnervation of the clitoris and/or vaginal surface in patients with a low spinal lesion or spina bifida: the TOMAX-procedure for Women

Reinnervation of the clitoris in patients with a low spinal lesion (Th12-L1) by nerve-transposition of the ilio-inguinal nerve towards the dorsal clotiridis nerve. By restoring the genital sensation in women with low spine lesion can increase the…