Clinical trial NCT01480778: Evaluation of Ciclo 21® Effect (Levonorgestrel + Ethinyl Estradiol) Compared to Nordette®.
Official title: Pharmacodynamic Assessment to Drug Ciclo 21 (Levonorgestrel + Ethinyl Estradiol) Market by União Química Farmacêutica Nacional S/A Compared to Drug Nordette of Wieth Indústria Farmacêutica Ltda.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irregular Periods
Keywords: hormonal response, levonorgestrel, ethinyl estradiol
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
Collaborators: name: União Química Farmacêutica Nacional S/A
First posted: 2011-11-29
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Comply with all study procedures, sign, initial and date back, of their own free will, the IC;
2. Women aged between 18 and 35 years, regardless of race and class;
3. Make use of safe non-hormonal method of contraception such as tubal ligation, non-hormonal IUDs or condoms, or be hysterectomised or be vasectomized sexual partner;
4. Examination of Beta-HCG negative;
5. with regular menstrual cycles every 24 to 32 days, at least the last three months;
6. present normal Pap test (current or during the past 02 years);
7. Present or vaginal examination found that the changes do not interfere in the study;
8. present levels of FSH, LH, estradiol and TT for the normal menstrual cycle, as well as normal transvaginal sonographic reports.

Exclusion Criteria:

1. Provide a contraindication to the use of steroids;
2. Use regular or prediction of drugs that interfere with the metabolism of the investigational products, such as antibiotics, anticonvulsants, anticoagulants and hypoglycemic drugs;
3. smokers or have stopped smoking less than 12 months;
4. Diabetic;
5. Toxic-dependent;
6. BMI \<18 and\> 25;
7. have made use of topical or systemic sex hormone for at least two months before the start of the study;
8. Background and personal or family history of thrombosis or bleeding disorders or vascular disorders or cardiovascular disease;
9. Laboratory tests, gynecological ultrasound or changed, the medical criteria;
10. Individuals with allergies or rheumatic diseases for which is indicated the use of cortico-steroid medication;
11. carry any endocrine changes, especially pituitary and gonadal and / or who are advised to use hormones;
12. with lesions or abnormalities suspected or confirmed in the gonads.
13. personal or family history of breast cancer or other hormone-dependent breast pathology;
14. with hypertension or diabetes mellitus (for drug interactions between the COC and hypoglycemic agents and antihypertensives);

a) History of nausea with oral use of COCs; p) Any condition that may interfere with the discretion of the investigator in the study data as well as being the measurement of the study be deleterious to the patient.

Primary outcomes:
measure: 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.
timeFrame: 1, 2, 4, 7, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 24 and 28 days
Secondary outcomes:
measure: 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.
timeFrame: PK: 1 (0, 1, 2, 3, 4, 5, 6, 12 e 18 hours after administration), 2, 7, 14, 21 and 28 days
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: LAL Clínica Pesquisa e Desenvolvimento Ltda
state: São Paulo
Study officials:
affiliation: LAL Clinica Pesquisa e Desenvolvimento Ltda
name: Alexandre Frederico, PI
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Benagiano G, Carrara S, Filippi V. Safety, efficacy and patient satisfaction with continuous daily administration of levonorgestrel/ethinylestradiol oral contraceptives. Patient Prefer Adherence. 2009 Nov 3;3:131-43. doi: 10.2147/ppa.s3692.
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citation: van Heusden AM, Fauser BC. Activity of the pituitary-ovarian axis in the pill-free interval during use of low-dose combined oral contraceptives. Contraception. 1999 Apr;59(4):237-43. doi: 10.1016/s0010-7824(99)00025-6.
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citation: Hemrika DJ, Slaats EH, Kennedy JC, de Vries Robles-Korsen TJ, Schoemaker J. Pulsatile luteinizing hormone patterns in long term oral contraceptive users. J Clin Endocrinol Metab. 1993 Aug;77(2):420-6. doi: 10.1210/jcem.77.2.8345046.
citation: Kroll R, Reape KZ, Margolis M. The efficacy and safety of a low-dose, 91-day, extended-regimen oral contraceptive with continuous ethinyl estradiol. Contraception. 2010 Jan;81(1):41-8. doi: 10.1016/j.contraception.2009.07.003.