Evaluation of Ciclo 21® Effect (Levonorgestrel + Ethinyl Estradiol) Compared to Nordette®.

This study has been completed.
Sponsor:
Collaborator:
União Química Farmacêutica Nacional S.A.
Information provided by (Responsible Party):
Azidus Brasil
ClinicalTrials.gov Identifier:
NCT01480778
First received: November 25, 2011
Last updated: March 2, 2016
Last verified: March 2016
  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
Irregular Periods
Drug: LNG+EE2
Drug: Nordette
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Azidus Brasil:

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 ]

Enrollment: 62
Study Start Date: July 2014
Study Completion Date: June 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LNG+EE2
pill test contained levonorgestrel 0,15 mg and ethynil estradiol 0,03 mg per day over 21 days
Drug: LNG+EE2
Administration of one pill contained 0.15 mg of levonosgestrel and 0.03 mg of ethynil estradiol per day over 21 days.
Other Name: Ciclo 21
Active Comparator: Nordette
pill comparator contained levonorgestrel 0,15 mg and ethynil estradiol 0,03 mg per day over 21 days
Drug: Nordette
Administration of one pill contained 0.15 mg of levonosgestrel and 0.03 mg of ethynil estradiol per day over 21 days.
Other Name: LNG+EE2

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Brazil
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil
Sponsors and Collaborators
Azidus Brasil
União Química Farmacêutica Nacional S.A.
Investigators
Principal Investigator: Alexandre Frederico, PI LAL Clinica Pesquisa e Desenvolvimento Ltda
  More Information

Publications:
Responsible Party: Azidus Brasil
ClinicalTrials.gov Identifier: NCT01480778     History of Changes
Other Study ID Numbers: LEEUNI0811 
Study First Received: November 25, 2011
Last Updated: March 2, 2016
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Azidus Brasil:
hormonal response, levonorgestrel, ethinyl estradiol

Additional relevant MeSH terms:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Ethinyl estradiol, levonorgestrel drug combination
Levonorgestrel
Polyestradiol phosphate
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Contraceptives, Oral, Synthetic
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 26, 2016