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

Phase 3

Withdrawn

• Conditions: Metrorrhagia
• Interventions: Drug: barrier methods

• Registration Number: NCT01557023
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-03
• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-03-16
• Study First Posted: 2012-03-19
• Study Start: 2013-07-01
• Primary Completion: 2014-12-01
• Study Completion: 2014-12-01
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dienogest 2 mg/ethynilestradiol 30 mcg;	barrier methods	-
Yasmin®	barrier methods	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Percentage of women with intracyclic bleeding during treatment cycles 2 to 7	2 and 7 cycles (each cycle is 21 days)

Trial Locations

Locations (1)

Instituto de Saúde e Bem Estar da Mulher; 🇧🇷 Sao Paulo, Brazil