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

Sponsor
Eurofarma Laboratorios S.A. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01557023
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
17
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: barrier methods
  • Drug: barrier methods
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Anticipated Study Start Date :
Jul 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2014
Anticipated Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: dienogest 2 mg/ethynilestradiol 30 mcg;

Drug: barrier methods
Active Comparator: Yasmin®

Drug: barrier methods

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. Percentage of women with intracyclic bleeding during treatment cycles 2 to 7 [2 and 7 cycles (each cycle is 21 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Instituto de Saúde e Bem Estar da Mulher Sao Paulo Brazil

Sponsors and Collaborators

  • Eurofarma Laboratorios S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01557023
Other Study ID Numbers:
  • EF 124 NINA
First Posted:
Mar 19, 2012
Last Update Posted:
Sep 21, 2017
Last Verified:
Mar 1, 2012
Additional relevant MeSH terms:
Metrorrhagia

Study Results

No Results Posted as of Sep 21, 2017