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

NCT ID: NCT01557023

Last Updated: 2017-09-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-01
• Study Completion Date: 2014-12-01

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.

Conditions

Metrorrhagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

dienogest 2 mg/ethynilestradiol 30 mcg;

Group Type: EXPERIMENTAL

barrier methods

Intervention Type: DRUG

Yasmin®

Group Type: ACTIVE_COMPARATOR

barrier methods

Intervention Type: DRUG

Interventions

barrier methods

Intervention Type: DRUG

barrier methods

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Instituto de Saúde e Bem Estar da Mulher

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

EF 124 NINA

Identifier Type: -

Identifier Source: org_study_id