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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01557023
Recruitment Status : Withdrawn (Change Company strategy)
First Posted : March 19, 2012
Last Update Posted : September 21, 2017
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.

Brief 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.

Condition or disease Intervention/treatment Phase
Metrorrhagia Drug: barrier methods Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Anticipated Study Start Date : July 1, 2013
Estimated Primary Completion Date : December 1, 2014
Estimated Study Completion Date : December 1, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Dienogest
U.S. FDA Resources

Arm Intervention/treatment
Experimental: dienogest 2 mg/ethynilestradiol 30 mcg; Drug: barrier methods
Active Comparator: Yasmin® Drug: barrier methods

Primary Outcome Measures :
  1. Occurrence of intracyclic bleeding and/or spotting during the cycles 2 and 3 of treatment [ Time Frame: 2 and 3 cycles (each cycle is 21 days) ]

Secondary Outcome Measures :
  1. Percentage of women with intracyclic bleeding during treatment cycles 2 to 7 [ Time Frame: 2 and 7 cycles (each cycle is 21 days) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01557023

Instituto de Saúde e Bem Estar da Mulher
Sao Paulo, Brazil
Sponsors and Collaborators
Eurofarma Laboratorios S.A.

Responsible Party: Eurofarma Laboratorios S.A. Identifier: NCT01557023     History of Changes
Other Study ID Numbers: EF 124 NINA
First Posted: March 19, 2012    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: March 2012

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