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CompletedNCT01480778Updated Mar 3, 2016

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

A Phase 3 interventional study of LNG+EE2 and Nordette in Irregular Periods, sponsored by Azidus Brasil. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-03.

Sponsored by Azidus Brasil · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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

Read the 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.
02

Conditions studied

  • Irregular Periods

Keywords

  • hormonal response, levonorgestrel, ethinyl estradiol
03

In context

Menstruation Disturbances

89 studies on the registry are indexed under Menstruation Disturbances; 21 are open to participants now.

This study's enrollment of 62 is close to the median of 60 across 54 interventional studies indexed under Menstruation Disturbances.

Browse Menstruation Disturbances studies →

Lead sponsor

Azidus Brasil is the lead sponsor of 80 studies on the registry; 5 are open to participants now.

Browse Azidus Brasil studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    LNG+EE2

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

    Drug: LNG+EE2

  • Active comparator
    Nordette

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

    Drug: Nordette

Interventions

  • DrugLNG+EE2

    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

  • DrugNordette

    Drug page: Ethinyl Estradiol-Norgestrel Combination

    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

06

What researchers measure

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.

    Time frame: 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.

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

07

Study locations

1 site
  • LAL Clínica Pesquisa e Desenvolvimento Ltda
    Valinhos, São Paulo, Brazil
08

References and documents

Publications

  • 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. PubMed 12906905 ↗
  • 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. PubMed 19936155 ↗
  • 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. PubMed 8934059 ↗
  • 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. PubMed 10457868 ↗
  • 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. PubMed 9306028 ↗
  • 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. PubMed 8345046 ↗
  • 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. PubMed 20004272 ↗

Individual participant data

Plan to share: Yes — The study data will be maked available after journal's approbation. The manuscript contained all of data it has been submitted.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01480778
Lead sponsor
Azidus Brasil
Collaborators
União Química Farmacêutica Nacional S/A
Responsible party
Sponsor
First posted
Nov 29, 2011
Start date
Jul 2014
Primary completion
Apr 2015
Completion
Jun 2015
Last update
Mar 3, 2016

Study contacts

Alexandre Frederico, PI
principal investigator · LAL Clinica Pesquisa e Desenvolvimento Ltda

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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