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Phase IIa, Double-Blind, Placebo-Controlled, Study of ESN364 Administered for 12 Weeks to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Women Presenting With Polycystic Ovarian Syndrome

The primary objective of the study is:To evaluate efficacy of two doses of ESN364 versus placebo when administered for 12 weeks to decrease total testosterone (TT) levelsThe Secondary objectives are:To evaluate effect of two doses of ESN364 versus…

FDC116115: A prospective study of sexual function in sexually active men treated for BPH

Primary: To assess the change in sexual function from baseline to 1 year in sexually active men with at least moderate BPH who are treated with Combodart, compared to placebo. Secondary: changes in sexual function during 1st 9 months of the study,…

A phase II randomized, double-blind, placebo-controlled trial of radium-223 dichloride versus placebo when administered to metastatic HER2 negative hormone receptor positive breast cancer subjects with bone metastases treated with hormonal treatment background therapy

The objective of this study is to assess the efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative), hormone receptor positive breast cancer with bone metastases treated with…

A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC).

OBJECTIVE AND HYPOTHESISPrimary ObjectiveThe primary objective is to determine whether abiraterone acetate in combination with low-doseprednisone and androgen deprivation therapy (ADT) is superior to ADT alone in improving rPFS and OS insubjects…

A phase II randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with exemestane and everolimus versus placebo in combination with exemestane and everolimus when administered to metastatic HER2 negative hormone receptor positive breast cancer subjects with bone metastases.

The objective of this study is to assess efficacy and safety of radium 223 dichloride in combination with exemestane and everolimus in subjects with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor positive breast cancer…

A Phase 3 study to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in subjects with castrate-resistant prostate cancer.

Am2: Primary Objective* To compare the Overall Survival (OS) benefit of docetaxel and prednisone with and without lenalidomide as first-line combination therapy in chemo-naïve metastatic CRPC Secondary Objectives* Progression-Free Survival (PFS), *…

A PHASE 2, RANDOMIZED, VEHICLE-CONTROLLED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EXPLORE THE PHARMACODYNAMICS, SAFETY AND EFFICACY OF TOPICAL OMIGANAN IN PATIENTS WITH EXTERNAL GENITAL WARTS.

Primary Objectives* To explore the pharmacodynamic effects of topically applied omiganan in patients with external genital warts* To explore clinical efficacy of omiganan compared to placebo in patients with external genital warts.Secondary…

Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs
Placebo in Asymptomatic or Minimally Symptomatic Patients with Metastatic
Chemotherapy-Naïve Castration Resistant Prostate Cancer

The objective of this study is to compare the overall survival of patients with prostate cancer who are no longer responding to hormone therapy (castration resistant) and who have not yet received chemotherapy live longer (overall survival) when…

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK 700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy

Primary Objective:• To determine if orteronel plus prednisone improves overall survival (OS)Key Secondary Objectives: • To determine if orteronel plus prednisone improves radiographic progression-free survival (rPFS)• To determine if orteronel plus…

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer

To determine if orteronel plus prednisone improves radiographic progression-freesurvival (rPFS)To determine if orteronel plus prednisone improves overall survival (OS)

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…

A RANDOMIZED, DOUBLE-BLIND, PHASE 3 TRIAL COMPARING IPILIMUMAB VS. PLACEBO FOLLOWING RADIOTHERAPY IN SUBJECTS WITH CASTRATION RESISTANT PROSTATE CANCER THAT HAVE RECEIVED PRIOR TREATMENT WITH DOCETAXEL

The objective of this study is to compare the overall survival of patients with castration resistant prostate cancer who have progressed after receiving docetaxel treatment, when they are treated with bone directed radiotherapy plus Ipilimumab…

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…

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…

Treatment of Endometriosis with Epigallocatechin gallate:
a double-blind randomized placebo-controlled crossover pilot trial.

To evaluate if Epigallocatechin gallate (EGCG) is an effective treatment for pain in endometriosis patients using oral contraceptives by using Visual Analogue Scores (VAS) * To evaluate if the VAS pain scores are lower after EGCG versus placebo…

A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs. Prednisone in Metastatic Castration-resistant Prostate Cancer Patients who have Received Prior Docetaxel and Prior Abiraterone or MDV3100

The objective of this study is to evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease…

The influence of peroperative dobutamine infusion on the blood flow of the DIEP-flap

Primary Objective: To investigate in a prospective randomized controlled trial whether intravenous infusion of low doses dobutamine solely peroperative or for 18 more hours postoperative in women undergoing a breast reconstruction by means of a DIEP…

A Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naïve Patients With Castration-Resistant Prostate Cancer

Primary objective:* To determine whether orteronel 300 mg twice daily (BID) plus prednisone 5 mg BID more effectively reduces serum testosterone levels, compared to placebo plus prednisone 5 mg BID, when administered to patients in JapanSecondary…

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…