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A phase IIIB, multicentre, multinational, randomized, open-label trial to compare the efficacy and safety of ovarian stimulation with GONAL-f day 1 to day 5 followed by Pergoveris starting day 6 to Pergoveris starting day 1 in women between 36 and 40 years of age undergoing assisted reproductive technique (ART)

The overall objective of this trial is to generate data on the ovarian stimulation profile obtained when Pergoveris® is started either on stimulation day 1 or stimulation day 6 in ART patients between 36 and 40 years of age (both inclusive). A…

The protective effect of tamoxifen in women with ER-positive breast cancer who opt for cryopreservation of oocytes or embryos: a prospectively controlled study.

The objective of this study is to investigate the relation between tamoxifen use during COS, endoxifen levels reached during COS, and recurrence-free survival (locoregional recurrence, distant recurrence or death from any cause) when compared with…

Prospective study on the treatment of congenital vaginal agenesis or vaginal hypoplasia - genital reconstruction, gynecological and urological aspects, psychosexual and social aspects and quality of life

Evaluation study on the effectiveness of a new developed vaginal dilatation programme for medical-psychological treatment of vaginal hypoplasia / agenesis.

Pilot study: performance of the Progensa PCA3 test in post-oxytocin urine specimens

The primary objective is to determine the yield of prostate cells in the urine specimen after oxytocin nasal spray, using a urine specimen with no manipulation as a reference method.

MR-guided focal laser ablation of the prostate: a pilot study

Main objective of this study is to test the feasibility and to determine the short and medium term histological cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment of localised prostate cancer. Secondary…

A phase I, mono-center, randomized, placebo and comparator controlled, single blind, rising dose, clinical study to determine single dose pharmacokinetics, pharmacodynamics, safety and tolerability of four doses of FSH-GEX* according to adaptive design (25, 75, 150 and 300 IU) administered subcutaneously in healthy pituitary-suppressed female volunteers

- To assess the safety and (local) tolerability of test compound following single rising dose administration by subcutaneous injection- To determine FSH pharmacokinetic parameters including Cmax and AUC0-last of test compound following single rising…

A prospective Multicenter Randomized Study Comparing Photoselective Vaporization of the Prostate with the GreenLight XPS Laser System and Transurethral resection of the Prostate for Treatment of benign Prostatis Hyperplasia

The study will compare procedural and post procedural outcomes for photoselective vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP). The study requires use of the CE marked GreenLight XPS* Laser System (GreenLight…

A rising multiple dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered SCH 900389 in healthy females (P07036)

To investigate the safety and tolerability of the test compoundTo study how the test compound is absorbed, broken-down and excreted by the bodyTo study the effect of the test compound on the functioning of the body, particularly the ovaries and sex…

Management of bartholin gland cyst and abscess: marsupialization or word catheter.

Marsupialization and placement of a word catheter for the management of the cyst or abscess of the bartholin gland will be studied. Medical effectiveness in terms of recurrence of the cyst or abscess after 1 year follow up will be evaluated. Patient…

A randomized phase II trial of docetaxel plus carboplatin versus docetaxel in hormone refractory prostate cancer patients who have progressed after response to prior docetaxel chemotherapy: RECARDO STUDY

Primary objectives:* Progression-free survival (PFS) defined as either of the following occurrences, whichever comes first:o PSA progression o Progressive disease according to RECIST when measurable diseaseSecondary objectives:* Toxicity profile.*…

Minimal Invasive versus Non Invasive treatment for symptomatic uterine fibroids: A randomized controlled trial comparing uterine artery embolization with magnetic resonance guided focused ultrasound (MINI TRIAL)

The objective of the MINI-trial is to compare the clinical effectiveness, quality of life, and cost-effectiveness of uterine artery embolisation (UAE) to MR guided focused ultrasound (MRgFUS) in pre- or perimenopausal women with symptomatic uterine…

A double blind, randomized, cross-over placebo controlled study to investigate the efficacy of sublingual testosterone solution on physiological and subjective arousal in healthy, sexually dysfunctional premenopausal women.

Primary objectives:To confirm the lack of effect of 0.5 mg sublingual testosterone on physiological and subjective measures of sexual arousal in women with HSDD. Secondary objective:To confirm the lack of effect of 0.5 mg sublingual testosterone on…

The influence of laparoscopic hernia repair on male fertility

This study is a pilot study to examine the presence of antisperm antibodies after laparoscopic groin hernia repair in men. The hypothesis of this pilot study is: After laparoscopic groin hernia repair with a mesh, antisperm antibodies can be…

A phase I, mono-center, placebo and comparator controlled, single-blind, randomized, parallel group, clinical study to determine multiple dose safety, tolerability, pharmacokinetics, and pharmacodynamics of FSH-GEX* administered subcutaneously in healthy pituitary-suppressed female volunteers

- To assess the safety and tolerability of FSH-GEX* following multiple dose administration by subcutaneous injection- To determine the pharmacokinetic profile of FSH-GEX* following multiple dose administration by subcutaneous injection- To assess…

Ovarian hyperstimulation in women with estrogen-receptor positive breastcancer who opt for embryo- or oocyte freezing: Is the Tamoxifen dosage sufficient to protect women against estrogen exposure? (TAMOXI project: a pilot study).

The objective of this pilot-study is to investigate if the current dosage of tamoxifen supplied to women with estrogen receptor positive breastcancer who opt for embryo- or oocyte freezing is protective during the whole period of hormone stimulation…

A phase I-II open label clinical trial, evaluating the efficacy and safety of administration of the therapeutic vaccine PEP-223/CoVaccine HT, to hormone treatment naive, immunocompetent subjects with T1-3, N0-1/x, M0 prostate cancer, eligible for hormone therapy.

primary aim of the study To investigate the efficacy of PEP-223/CoVaccine HT in decreasing serum testosterone levels to below castrate levels, i.e. to < 2 nmol/l, within 8 weeks after the last of three injectionssecondary aims of the studyTo…

A Randomized, Open Label, Phase III, Multicenter, 2-Arm Study of Androgen deprivation +/- Taxoterere* (Docetaxel) for Non metastatic Prostate Cancer Patients with a Rising PSA.

To evaluate and compare progression free survival (PSA) between the two treatment arms.

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of MORAb-003 (farletuzumab) in Combination with Paclitaxel Therapy in Subjects with Platinum-Resistant or Refractory Relapsed Ovarian Cancer

To compare the effect of paclitaxel plus MORAb-003 to paclitaxel plus placebo on progression free survival (PFS) as determined by RECIST in subjects who are in a first platinum-resistant or refractory relapse of ovarian cancer.

A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation

To determine if an on demand dosing of 50 or 150 mg of GSK557296 demonstratessuperior efficacy with respect to duration of IELT during an 8 week study periodcompared to placebo in men with premature ejaculation.To assess safety and tolerability of…

PharmacoKINEtics of TAMoxifen and its metabolites in breast cancer patients: the influence of a dose increase in phenotypic poor metabolizers of CYP2D6 (KINETAM)

Primary: To evaluate the effect of a dose increase to 40mg tamoxifen QD for 4 weeks in patients with at least one CYP2D6 variant allele and/or the presence of a CYP2D6 inhibitorSecondary:To evaluate the effect of concomitant use of (potential)…