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Clinical Trials Phase News

Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will norma...

Acute Phase Reactants

FDA Accepts Repros' Phase 3 Efficacy Protocol for Androxal(R) Under a Special Protocol Assessment Agreement

THE WOODLANDS, Texas, July 9, 2012 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced it has reached agreement with the FDA for the design of the pivotal efficacy studies fo...

Emergent BioSolutions provides update on TRU-016 Phase 1b study

Emergent BioSolutions Inc. today announced its decision to expand the protocol for its ongoing Phase 1b, single arm, open label study (Protocol 16009) evaluating the safety and efficacy of TRU-016 in...

Haematological cancer: The rule of three in AML induction—is cladribine the answer?

In a randomized phase III trial of induction therapy in adult acute myeloid leukaemia, the addition of cladribine, but not fludarabine, to daunorubicin and cytarabine seemed to improve complete respon...

Provectus amends and expands protocol for PV-10 Phase 1 hepatocellular carcinoma study

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced that it has amended and expanded the scope of the protocol PV-10-LC-01, "A Phase 1 St...

[Articles] Induction chemotherapy followed by concurrent chemoradiotherapy (sequential chemoradiotherapy) versus concurrent chemoradiotherapy alone in locally advanced head and neck cancer (PARADIGM): a randomised phase 3 trial

Although survival results were good in both groups there was no difference noted between those patients treated with induction chemotherapy followed by chemoradiotherapy and those who received chemora...

Induction of hyperhomocysteinemia models vascular dementia by induction of cerebral microhemorrhages and neuroinflammation

ISP of Chile approves Trigemina's protocol for Phase 2 clinical study of TI-001

Trigemina, Inc., a biopharmaceutical company focused on the discovery and development of non-narcotic, nasally delivered, analgesic drug products, today announced that the Instituto de Salud Publica o...

Teva to Initiate Third Phase III Trial of Oral Laquinimod for the Treatment of Relapsing ...

The clinical trial protocol has been granted a Special Protocol Assessment agreement by the Food and Drug Administration

Prediction of successful labor induction by evaluation of maternal symptoms at an early stage of the misoprostol induction protocol.

Abstract Objective: This prospective observational study evaluated maternal symptoms and characteristics that predict successful labor induction with oral misoprostol. Methods: A total of 244 consecut...

Luteal blood flow in patients undergoing GnRH agonist long protocol.

ABSTRACT: BACKGROUND: Blood flow in the corpus luteum (CL) is closely related to luteal function. It is unclear how luteal blood flow is regulated. Standardized ovarian-stimulation protocol with a gon...

Phosphorylation-state-dependent regulation of NMDA receptor short-term plasticity modifies hippocampal dendritic Ca2+ transients.

N-methyl-D-aspartate (NMDA) receptor-mediated currents are enhanced by phosphorylation. We have investigated effects of phosphorylation-dependent short-term plasticity of NMDA receptor-mediated EPSCs...

Risk factors for development of sterile haemorrhagic cystitis in canine lymphoma patients receiving oral cyclophosphamide: a case-control study.

Sterile haemorrhagic cystitis (SHC) is a known risk of cyclophosphamide treatment; however, most canine reports are case series. This case-control study examined risk factors for SHC in dogs with lymp...

A pre-validation transferability study of the GreenScreen HC GADD45a-GFP assay with a metabolic activation system (S9).

A new protocol has recently been developed and validated for the GreenScreen HC GADD45a-GFP genotoxicity reporter assay, enabling the incorporation of an S9 metabolic activation system into the assay....