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

Eurofarma

Status and phase

Withdrawn

Phase 3

Conditions

Metrorrhagia

Treatments

Drug: barrier methods

Study type

Interventional

Funder types

Industry

Identifiers

NCT01557023

EF 124 NINA

Details and patient eligibility

About

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.

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.