Clinical Trial With Combination of Dienogest/Ethytnilestradiol and Drosperidona/Ethyniestradiol

Last updated: September 19, 2017
Sponsor: Eurofarma Laboratorios S.A.
Overall Status: Trial Not Available

Phase

3

Condition

Menstrual Disorders

Female Hormonal Deficiencies/abnormalities

Dysfunctional Uterine Bleeding

Treatment

N/A

Clinical Study ID

NCT01557023
EF 124 NINA
  • Ages 18-35
  • Female
  • Accepts Healthy Volunteers

Study Summary

This trial will study the percentage of women with at least one occurrence of intracyclic bleeding (bleeding and/or spotting) during the cycles 2 and 3 of treatment with test or reference drug.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Sign, initial and date the informed consent form;

  • Female patients, with child bearing potential, aged 18 to 35 years;

  • Have indication to receive progesterone and estrogen-based low oral hormone treatmentfor at least 7 cycles (approximately 7 months) for birth control;

  • Be able to comply with the study protocol;

  • Show normal result in cervical-vaginal cytology conducted up to 3 months before studyenrollment or be willing to repeat the screening visit test, which result must also benormal;

  • Be willing to use one of the study drugs

Exclusion

Exclusion Criteria:

  • Is pregnant or breastfeeding, suspecting to be or planning to get pregnant;

  • Patients currently using oral contraceptives with drospirenone 3 mg/ ethynilestradiol 30 mcg or dianogest 2 mg/ ethynilestradiol 30 mcg.

  • Have history of gynecologic surgery such as hysterectomy, total oophorectomy or tuballigation;

  • Smoke over 10 cigarettes a day;

  • Have any severe comorbidities (at the investigator's criteria), including bowelinflammatory disease

  • Have hypertension, showing at least one of the following conditions: Systolic pressure >140 mm Hg or diastolic pressure >90 mm Hg in sitting position;

  • Current use of pharmacological treatment for hypertension;

  • Show history or currently have venous or arterial thromboembolism;

  • History of breast or genital cancer;

  • Have obesity (BMI >30 kg/m2);

  • Have liver disease or changed lab values;

  • Currently have dysplasia or malignancy in cervical-vaginal cytology;

  • Concomitantly use CYP3A4 metabolizing drugs or drugs causing drug interaction withother study drugs;

  • History of abortion one (1) month before study enrollment;

  • History of childbirth or breastfeeding 3 months before study enrollment;

  • Have hypersensitivity to any of the study drug components;

  • Patients with long-term disability, who have undergone a major surgery or any surgeryin legs or major traumatism in the last 6 months;

  • Have current diagnosis of sexually transmitted disease;

  • Have used injectable hormones 3 months before study enrollment;

  • Have used hormone implant 6 months before study enrollment;

  • Have participated in another clinical trial in the last 12 months.

Study Design

Study Start date:
July 01, 2013
Estimated Completion Date:
December 01, 2014

Connect with a study center

  • Instituto de Saúde e Bem Estar da Mulher

    Sao Paulo,
    Brazil

    Site Not Available

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