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

NCT01480778 | Completed Phase 3 DMC

• 1 other identifier: LEEUNI0811
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Conditions

Irregular Periods

Keywords

hormonal response, levonorgestrel, ethinyl estradiol

Outcome Measures

Primary Outcomes (1)

• 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.

  1, 2, 4, 7, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 24 and 28 days

Secondary Outcomes (1)

• 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.

  PK: 1 (0, 1, 2, 3, 4, 5, 6, 12 e 18 hours after administration), 2, 7, 14, 21 and 28 days

Study Arms (2)

LNG+EE2

EXPERIMENTAL

pill test contained levonorgestrel 0,15 mg and ethynil estradiol 0,03 mg per day over 21 days

Drug: LNG+EE2

Nordette

ACTIVE COMPARATOR

pill comparator contained levonorgestrel 0,15 mg and ethynil estradiol 0,03 mg per day over 21 days

Drug: Nordette

Interventions

LNG+EE2 DRUG

Administration of one pill contained 0.15 mg of levonosgestrel and 0.03 mg of ethynil estradiol per day over 21 days.

Also known as: Ciclo 21

LNG+EE2

Nordette DRUG

Administration of one pill contained 0.15 mg of levonosgestrel and 0.03 mg of ethynil estradiol per day over 21 days.

Also known as: LNG+EE2

Nordette

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Comply with all study procedures, sign, initial and date back, of their own free will, the IC;
• Women aged between 18 and 35 years, regardless of race and class;
• 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;
• Examination of Beta-HCG negative;
• with regular menstrual cycles every 24 to 32 days, at least the last three months;
• present normal Pap test (current or during the past 02 years);
• Present or vaginal examination found that the changes do not interfere in the study;
• present levels of FSH, LH, estradiol and TT for the normal menstrual cycle, as well as normal transvaginal sonographic reports.

You may not qualify if:

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

Sponsors & Collaborators

• Azidus Brasil: lead
• União Química Farmacêutica Nacional S/A: collaborator

Study Sites (1)

LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Location

Related Publications (7)

• Twaddle NC, Churchwell MI, Newbold RR, Delclos KB, Doerge DR. Determination using liquid-chromatography-electrospray tandem mass spectroscopy of ethinylestradiol serum pharmacokinetics in adult Sprague-Dawley rats. J Chromatogr B Analyt Technol Biomed Life Sci. 2003 Aug 15;793(2):309-15. doi: 10.1016/s1570-0232(03)00331-3.

  PMID: 12906905 RESULT

• 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.

  PMID: 19936155 RESULT

• Crosignani PG, Testa G, Vegetti W, Parazzini F. Ovarian activity during regular oral contraceptive use. Contraception. 1996 Nov;54(5):271-3. doi: 10.1016/s0010-7824(96)00178-3.

  PMID: 8934059 RESULT

• 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.

  PMID: 10457868 RESULT

• Rossmanith WG, Steffens D, Schramm G. A comparative randomized trial on the impact of two low-dose oral contraceptives on ovarian activity, cervical permeability, and endometrial receptivity. Contraception. 1997 Jul;56(1):23-30. doi: 10.1016/s0010-7824(97)00070-x.

  PMID: 9306028 RESULT

• 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.

  PMID: 8345046 RESULT

• 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.

  PMID: 20004272 RESULT

MeSH Terms

Conditions

Menstruation Disturbances

Interventions

Ethinyl Estradiol-Norgestrel Combination

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethinyl Estradiol; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norgestrel; Norpregnenes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Alexandre Frederico, PI

  LAL Clinica Pesquisa e Desenvolvimento Ltda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2011
• First Posted: November 29, 2011
• Study Start: July 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 3, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)