Hortolandia

Researchers are evaluating the efficacy and safety of an experimental drug called CDE100 for treating menstrual cramp pain in females diagnosed with primary dysmenorrhea. This Phase III study compares CDE100 with an active comparator, Buscopan Composto, to better understand its effects on menstrual pain relief. Participants will receive either CDE100 or Buscopan Composto in a randomized, double-blind, double-dummy, crossover design where each participant receives both treatments in sequence during the study. The treatments are given during menstrual cycles, and the study carefully monitors pain relief following dosing. During the study, participants will be assessed for pain relief over the first 4 hours after taking the medication, with the main measure being the total pain relief sum during that period. Safety and efficacy data will be collected throughout, and participants will be closely monitored to evaluate the treatments' effects on menstrual cramp pain. The study includes females aged 16 to 35 years with a history of primary dysmenorrhea and regular menstrual cycles.

Researchers are evaluating the effectiveness and safety of the Madalena association in treating type 2 diabetes mellitus. This Phase III clinical trial compares Madalena association with metformin and empagliflozin plus linagliptin treatments, including placebo controls, to assess their impacts on blood sugar control. Participants will receive coated tablets of Madalena association, metformin extended-release, or empagliflozin plus linagliptin, or their matching placebos. The study is randomized, double-blind, and uses a triple-dummy design to ensure unbiased results assessing these treatments for type 2 diabetes. During the 120-day treatment period, researchers will monitor changes in glycated hemoglobin (HbA1c) from baseline to evaluate blood sugar control. Participants will undergo regular assessments to ensure safety and treatment adherence throughout the study duration.

Researchers are evaluating the efficacy and safety of the Piemonte association in treating type 2 diabetes mellitus. This phase III clinical trial aims to study how well this treatment works and its safety profile in adults who have type II diabetes and have not achieved their blood sugar goals with diet, exercise, or stable previous therapies. Participants will receive different treatments including Piemonte association tablets, empagliflozin tablets, pioglitazone tablets, or their respective placebos. Each medication or placebo is taken once daily as a coated tablet. The study design is randomized, double-blind, and triple-dummy to ensure unbiased results. During the study, researchers will monitor glycated hemoglobin (HbA1c) levels at 120 days to assess blood sugar control. Participants will be closely observed for safety and treatment effects throughout the trial. The total participation time and follow-up details are organized to track outcomes and any side effects.