Assessment of the pharmacodynamic profile of the drug Ciclo 21 ®, marketed by União Química Farmacêutica Nacional S / A, compared to the drug Nordette ® Laboratory Wyeth Pharmaceutical Ltda. Through the modulation of hormonal response (inhibition of the pituitary) evidenced by measurement serum LH and FSH for 28 days, as well as by the absence of follicle formation demonstrated by transvaginal ultrasound examinations
secondary objective * Evaluation of the safety aspects of medicines such as type, frequency and intensity of adverse events between groups during the 28 day trial. exploratory objective * Evaluation of the pharmacokinetics of the drug administered through the dosage of serum hormone levonorgestrel and ethinyl estradiol for 28 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
62
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil
The primary efficacy endpoint will be the changes in FSH and LH secretion induced by daily administration of the drug for 21 consecutive days during the 28 days of participation in the trial.
Time frame: 1, 2, 4, 7, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 24 and 28 days
Safety of drugs: type, frequency and intensity of adverse events between groups during the 28 day trial. Exploratory investigation of the pharmacokinetics of the drug administered through the dosage of hormones in serum LNG and EE2 for 28 days.
Time frame: PK: 1 (0, 1, 2, 3, 4, 5, 6, 12 e 18 hours after administration), 2, 7, 14, 21 and 28 days
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