Metrorrhagia
Conditions
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.
Interventions
DRUGbarrier methods
Sponsors
Eurofarma Laboratorios S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of intracyclic bleeding and/or spotting during the cycles 2 and 3 of treatment | 2 and 3 cycles (each cycle is 21 days) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of women with intracyclic bleeding during treatment cycles 2 to 7 | 2 and 7 cycles (each cycle is 21 days) |
Countries
Brazil
Outcome results
None listed