Clinical trial NCT01557023: Clinical Trial With Combination of Dienogest/Ethytnilestradiol and Drosperidona/Ethyniestradiol
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Metrorrhagia
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2012-03-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Occurrence of intracyclic bleeding and/or spotting during the cycles 2 and 3 of treatment
timeFrame: 2 and 3 cycles (each cycle is 21 days)
Secondary outcomes:
measure: Percentage of women with intracyclic bleeding during treatment cycles 2 to 7
timeFrame: 2 and 7 cycles (each cycle is 21 days)
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto de Saúde e Bem Estar da Mulher
Study officials:
References: