Evaluation Of The Product Ciclo® 21 Pharmacodynamics (Levonorgestrel + Ethinyl Estradiol), Marketed By União Química Farmacêutica Nacional S / A, Compared To Nordette® Product To The Lab Wyeth Pharmaceutical Industries Ltd.

This study is not yet open for participant recruitment.
Verified March 2013 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Sponsor:
Information provided by (Responsible Party):
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01480778
First received: November 25, 2011
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Pregnancy Prevention
Control of Menstrual Irregularities
Drug: Ciclo 21 (LNG + EE2); União Química Farmacêutcia Nacional S/A
Drug: Nordette (LNG + EE2); Laboratory Wyeth Pharmaceutical Ltda
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

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Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test
Ciclo 21 (LNG + EE2; União Química Farmacêutcia Nacional S/A
Drug: Ciclo 21 (LNG + EE2); União Química Farmacêutcia Nacional S/A
Ciclo 21: Levonorgestrel (0.15 mg) + ethinyl estradiol (0.03 mg) - 21 doses
Active Comparator: Comparator
Nordette (LNG + EE2); Laboratory Wyeth Pharmaceutical Ltda
Drug: Nordette (LNG + EE2); Laboratory Wyeth Pharmaceutical Ltda
Nodette: Levonorgestrel (0.15 mg) + ethinyl estradiol (0.03 mg) - 21 doses

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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480778

Contacts
Contact: Alexandre Frederico, phsycian 55 19 3871-6399 alexandre@lalclinica.com.br

Locations
Brazil
LAL Clínica Pesquisa e Desenvolvimento Ltda Not yet recruiting
Valinhos, São Paulo, Brazil
Contact: Alexandre Frederico, phsycian    55 19 3871-6399    alexandre@lalclinica.com.br   
Principal Investigator: Alexandre Frederico, phsician         
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier: NCT01480778     History of Changes
Other Study ID Numbers: LEEUNI0811, Version 01
Study First Received: November 25, 2011
Last Updated: March 13, 2013
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Ethinyl Estradiol
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Ethinyl Estradiol-Norgestrel Combination
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptives, Oral, Combined
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital

ClinicalTrials.gov processed this record on April 17, 2014