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Irregular PeriodsPhase 3NCT01480778

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

A Phase 3 study testing LNG+EE2 and Nordette in people with Irregular Periods, run by Azidus Brasil at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Irregular Periods
What is being tested?
LNG+EE2 and Nordette
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteBrazil
Study dates
Jul 2014to Jun 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 15Show fewer
  • 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);
  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • LAL Clínica Pesquisa e Desenvolvimento Ltda

    Valinhos, São Paulo

Other trials in Brazil

About this study

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.

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.
Being tested
LNG+EE2, Nordette
Keywords
hormonal response, levonorgestrel, ethinyl estradiol
Medical subject headings
Menstruation Disturbances

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LNG+EE2Drug

    Also called Ciclo 21

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

  • NordetteDrug

    Also called LNG+EE2

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

Study groups in NCT01480778
Study groupRoleWhat they receive
LNG+EE2Experimentalpill test contained levonorgestrel 0,15 mg and ethynil estradiol 0,03 mg per day over 21 days
Receives: Drug: LNG+EE2
NordetteActive comparatorpill comparator contained levonorgestrel 0,15 mg and ethynil estradiol 0,03 mg per day over 21 days
Receives: Drug: Nordette

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2011 (estimated)
  2. Study startJul 2014
  3. Primary completionApr 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01480778
Sponsor's protocol ID
LEEUNI0811
Status last verified
Mar 2016
First submitted
25 Nov 2011
Last updated
3 Mar 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: The study data will be maked available after journal's approbation. The manuscript contained all of data it has been submitted.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LNG+EE2 and Nordette in people with Irregular Periods, run by Azidus Brasil at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 1, 2, 4, 7, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 24 and 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01480778, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.

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