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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Eurofarma Laboratorios S.A..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01557023
First received: March 8, 2012
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Metrorrhagia
Drug: barrier methods
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)

Resource links provided by NLM:


Further study details as provided by Eurofarma Laboratorios S.A.:

Primary Outcome Measures:
  • Occurrence of intracyclic bleeding and/or spotting during the cycles 2 and 3 of treatment

Secondary Outcome Measures:
  • Percentage of women with intracyclic bleeding during treatment cycles 2 to 7

Estimated Enrollment: 656
Arms Assigned Interventions
Experimental: dienogest 2 mg/ethynilestradiol 30 mcg; Drug: barrier methods
Active Comparator: Yasmin® Drug: barrier methods

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 treatment for 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 study enrollment or be willing to repeat the screening visit test, which result must also be normal;
  • Be willing to use one of the study drugs

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 tubal ligation;
  • Smoke over 10 cigarettes a day;
  • Have any severe comorbidities (at the investigator's criteria), including bowel inflammatory 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 with other 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 surgery in 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557023

Contacts
Contact: Cesar Fernandes, master 551141449681

Locations
Brazil
Instituto de Saúde e Bem Estar da Mulher Not yet recruiting
Sao Paulo, Brazil
Contact: Cesar Fernandes, Master         
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
  More Information

No publications provided

Responsible Party: Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier: NCT01557023     History of Changes
Other Study ID Numbers: EF 124 NINA
Study First Received: March 8, 2012
Last Updated: March 16, 2012
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Metrorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes
Dienogest
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents, Male

ClinicalTrials.gov processed this record on April 23, 2014