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

Metrorrhagia Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01557023
• Other study ID #: EF 124 NINA
• Status: Withdrawn
• Phase: Phase 3
• First received: March 8, 2012
• Last updated: September 19, 2017
• Start date: July 1, 2013
• Est. completion date: December 1, 2014

Study information

• Verified date: March 2012
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2014
• Est. primary completion date: December 1, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metrorrhagia

Intervention

Drug:
• barrier methods

• barrier methods

Locations

Country	Name	City	State
Brazil	Instituto de Saúde e Bem Estar da Mulher	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of women with intracyclic bleeding during treatment cycles 2 to 7		2 and 7 cycles (each cycle is 21 days)