Back to resultsClinical Trial With Combination of Dienogest/Ethytnilestradiol and Drosperidona/Ethyniestradiol
Primary Purpose
Metrorrhagia
Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
barrier methods
barrier methods
Sponsored by
About this trial
This is an interventional treatment trial for Metrorrhagia
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.
Sites / Locations
- Instituto de Saúde e Bem Estar da Mulher
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
dienogest 2 mg/ethynilestradiol 30 mcg;
Yasmin®
Arm Description
Outcomes
Primary Outcome Measures
Occurrence of intracyclic bleeding and/or spotting during the cycles 2 and 3 of treatment
Secondary Outcome Measures
Percentage of women with intracyclic bleeding during treatment cycles 2 to 7
Full Information
NCT ID
NCT01557023
First Posted
March 8, 2012
Last Updated
September 19, 2017
Sponsor
Eurofarma Laboratorios S.A.
1. Study Identification
Unique Protocol Identification Number
NCT01557023
Brief Title
Clinical Trial With Combination of Dienogest/Ethytnilestradiol and Drosperidona/Ethyniestradiol
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Change Company strategy
Study Start Date
July 1, 2013 (Anticipated)
Primary Completion Date
December 1, 2014 (Anticipated)
Study Completion Date
December 1, 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eurofarma Laboratorios S.A.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metrorrhagia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dienogest 2 mg/ethynilestradiol 30 mcg;
Arm Type
Experimental
Arm Title
Yasmin®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
barrier methods
Intervention Type
Drug
Intervention Name(s)
barrier methods
Primary Outcome Measure Information:
Title
Occurrence of intracyclic bleeding and/or spotting during the cycles 2 and 3 of treatment
Time Frame
2 and 3 cycles (each cycle is 21 days)
Secondary Outcome Measure Information:
Title
Percentage of women with intracyclic bleeding during treatment cycles 2 to 7
Time Frame
2 and 7 cycles (each cycle is 21 days)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Instituto de Saúde e Bem Estar da Mulher
City
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial With Combination of Dienogest/Ethytnilestradiol and Drosperidona/Ethyniestradiol
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