Hortolandia

Researchers are evaluating the efficacy and safety of CDE100 for treating menstrual cramp pain associated with primary dysmenorrhea in females aged 16 to 35 years. This phase III randomized, double-blind, double-dummy crossover study compares CDE100 to Buscopan4 Composto in managing moderate to severe menstrual cramps. The study aims to better understand pain relief over several hours post-dose and monitor safety over an extended period. Participants receive either CDE100 with a placebo of Buscopan4 Composto or Buscopan4 Composto with a placebo of CDE100. They take one pill of the assigned medication as needed for pain, up to three times daily. The crossover design means participants will switch treatments during the study, allowing comparison within the same individual. Treatment periods are closely monitored for pain relief and medication use. During the study, participants will have their pain relief evaluated using specific measures like the Sum of Total Pain Relief TOTPAR over 4 and 8 hours and the Sum of Pain Intensity Difference SPID. Researchers will also track use of rescue medication, patients overall impression of change, and safety for up to 175 days. Participants can expect regular assessments and data collection on their menstrual pain and response to treatments throughout the study period.

Researchers are evaluating the efficacy and safety of the Madalena association in treating adults with type 2 diabetes mellitus who have not achieved their blood sugar goals with diet, exercise, and dual anti-hyperglycemic therapy. This phase III, randomized, double-blind study compares Madalena association with a combination of metformin, empagliflozin, and linagliptin to better understand its impact on blood sugar control. Participants take three tablets once daily according to their assigned group one group receives the Madalena association tablet plus placebos for the other treatments, while the other group takes metformin and empagliflozin plus linagliptin tablets with a Madalena placebo. The study uses a triple-dummy design to keep treatment assignments blinded and monitors outcomes over about 120 to 150 days. During the study, participants will have their glycated hemoglobin HbA1c levels measured after 120 days to assess blood sugar control changes. Safety is monitored by recording any side effects or adverse events over approximately 150 days. Participants will attend regular visits for evaluations, blood tests, and adherence checks to ensure accurate monitoring of treatment effects and safety throughout the trial.

Researchers are evaluating the efficacy and safety of the Piemonte association in treating type 2 diabetes mellitus. This phase III, randomized, double-blind clinical trial aims to compare Piemonte with empagliflozin and pioglitazone. The study includes adult participants who have not achieved their HbA1c targets despite stable doses of diet, exercise, and prior therapies. Participants will be assigned to one of three groups in a triple-dummy design. Each participant takes three tablets daily one active drug and two matching placebos. The groups include Piemonte association, empagliflozin 25 mg, or pioglitazone 30 mg. This approach ensures blinding while assessing the effects of each treatment. During the 120-day treatment period, researchers will monitor the primary outcome of glycated hemoglobin levels. Secondary measures include monitoring adverse events over 150 days. Participants will be evaluated regularly to assess safety and treatment effects. The total involvement spans several months, ensuring thorough assessment of outcomes and safety.