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NCT ID: NCT03088137 Completed - Infertility, Female Clinical Trials

Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment

Start date: February 8, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to show equivalence with regard to the number of oocytes retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing IVF/ICSI

NCT ID: NCT03086486 Completed - Tuberculosis Clinical Trials

Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis

ZeNix
Start date: November 21, 2017
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy, safety and tolerability of various doses and durations of linezolid plus bedaquiline and pretomanid after 26 weeks of treatment in participants with either pulmonary XDR-TB, pre-XDR-TB, or treatment intolerant or non-responsive MDR-TB.

NCT ID: NCT03086343 Completed - Clinical trials for Rheumatoid Arthritis (RA)

A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs

Start date: May 9, 2017
Phase: Phase 3
Study type: Interventional

The study objective of Period 1 was to compare the safety and efficacy of upadacitinib 15 mg once daily (QD) to abatacept on a background of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in biologic disease-modifying antirheumatic drug (bDMARD)-inadequate response or bDMARD-intolerant participants with moderately to severely active RA. The study objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD in participants with RA who had completed Period 1.

NCT ID: NCT03086330 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus

SUSTAIN 9
Start date: March 15, 2017
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication.

NCT ID: NCT03085797 Completed - Nasal Polyps Clinical Trials

Effect of Mepolizumab in Severe Bilateral Nasal Polyps

Start date: May 25, 2017
Phase: Phase 3
Study type: Interventional

Nasal polyps (NP) has long been known as chronic inflammatory disease of the nasal mucosa. This disease is characterized by the presence of polyps in the upper nasal cavity, originating from within the ostiomeatal complex. The presence of polyps can cause long-term symptoms such as prominent nasal obstruction, post-nasal drip, loss of smell, and discharge. Mepolizumab (SB240563) is an Immunoglobulin G 1 [IgG1], kappa humanized monoclonal antibody (mAB) that blocks human interleukin-5 (hIL-5) from binding to the interleukin-5 (IL-5) receptor complex expressed on the eosinophil cell surface and thus inhibits signaling. Neutralization of IL-5 with mepolizumab has been shown to reduce blood, sputum and tissue eosinophils and hence is assumed to be a treatment option in a number of eosinophilic diseases including NP. The aim of this randomized, double-blind, parallel group, phase 3 (PhIII) study is to assess the clinical efficacy and safety of 100 milligram (mg) subcutaneous (SC) mepolizumab as an add on to maintenance treatment in adults with severe bilateral NP. The study will include a 4-week run in period followed by randomization to a 52-week treatment period. Participants will receive mepolizumab 100 mg or placebo SC by the investigator or delegate via a pre-filled safety syringe every 4 weeks for 52 weeks. Throughout the entire study period (run in + treatment period + follow up), participants will receive a standard of care (SoC) for NP which consists of daily mometasone furorate (MF) nasal spray, and if required, saline nasal douching, occasional short courses of high dose oral corticosteroids (OCS) and/or antibiotics. The treatment period will consist of thirteen, 4-weekly doses of mepolizumab or placebo. In addition, up to the first 200 randomized participants will be followed up every other month for up to a further 6 months after the Visit 15 (7 months post last dose) in order to assess maintenance of response and to validate a physiological model derived from the previous Phase 2 study. Approximately 400 participants will be randomized (200 participants per treatment arm) in to the study. Total duration of the study will be 76 weeks for first 200 randomized participants and 52 weeks for remainder of participants who are not participating in the 6 months no treatment follow up.

NCT ID: NCT03080298 Completed - Clinical trials for Hypoactive Sexual Desire Disorder (HSDD)

Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire

Start date: March 14, 2016
Phase: Phase 2
Study type: Interventional

This is study of the efficacy, safety and pharmacokinetics of BP101 compared to placebo in patients with a decrease or loss of sexual desire.

NCT ID: NCT03078036 Completed - Breast Cancer Clinical Trials

International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study

BREAKOUT
Start date: March 13, 2017
Phase:
Study type: Observational

BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study BREAKOUT is a prospective cross-sectional cohort study of human epidermal growth factor receptor 2 negative metastatic breast cancer patients who have started 1st line systemic cytotoxic chemotherapy. The study will estimate the prevalence of germline breast cancer susceptibility gene in an otherwise unselected population, describe the treatments administered and estimate the associated clinical outcomes of overall survival and progression-free survival amongst mutation carriers within the context of a low poly ADP ribose polymerase inhibitor treatment setting. Other exploratory analyses may be undertaken to describe somatic breast cancer susceptibility gene and other homologous recombination repair gene mutations.

NCT ID: NCT03077607 Completed - Clinical trials for Advanced Solid Tumors

A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors

Start date: November 7, 2016
Phase: Phase 1
Study type: Interventional

This is a study in patients with advanced solid tumors for the investigation of P-gp inhibition and induction on the PK of talazoparib.

NCT ID: NCT03076138 Completed - Bone Loss Clinical Trials

Gene-activated Bone Substitute for Maxillofacial Bone Regeneration

Start date: March 6, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of the gene-activated bone substitute consisting of octacalcium phosphate and plasmid DNA encoding vascular endothelial growth factor (VEGF) for maxillofacial bone regeneration. The patients with congenital and acquired maxillofacial bone defects and alveolar ridge atrophy will be enrolled.

NCT ID: NCT03074045 Completed - Contraception Clinical Trials

LCS16 vs. COC User Satisfaction and Tolerability Study

Start date: March 13, 2017
Phase: Phase 3
Study type: Interventional

To evaluate user satisfaction in young nulliparous and parous women (18-29 years of age [inclusive]), using LCS16 compared to a COC over a period of 12 months.