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

NCT01557023 | Withdrawn Phase 3 DMC

• 1 other identifier: EF 124 NINA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Metrorrhagia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of women with intracyclic bleeding during treatment cycles 2 to 7

  2 and 7 cycles (each cycle is 21 days)

Study Arms (2)

dienogest 2 mg/ethynilestradiol 30 mcg;

EXPERIMENTAL

Drug: barrier methods

Yasmin®

ACTIVE COMPARATOR

Drug: barrier methods

Interventions

barrier methods DRUG

dienogest 2 mg/ethynilestradiol 30 mcg;

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

Instituto de Saúde e Bem Estar da Mulher

São Paulo, Brazil

Location

MeSH Terms

Conditions

Metrorrhagia

Interventions

Contraception, Barrier

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Contraception; Reproductive Techniques; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 19, 2012
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 21, 2017

Record last verified: 2012-03

Locations

BR (1)