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

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.

Study Overview

• Status: Withdrawn
• Conditions: Metrorrhagia
• Intervention / Treatment: Drug: barrier methods

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Instituto de Saúde e Bem Estar da Mulher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dienogest 2 mg/ethynilestradiol 30 mcg;	Drug: barrier methods
Active Comparator: Yasmin®	Drug: barrier methods

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2013
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: March 8, 2012
• First Submitted That Met QC Criteria: March 16, 2012
• First Posted (Estimate): March 19, 2012

Study Record Updates

• Last Update Posted (Actual): September 21, 2017
• Last Update Submitted That Met QC Criteria: September 19, 2017
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Uterine Hemorrhage; Metrorrhagia
• Other Study ID Numbers: EF 124 NINA