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WithdrawnNCT01557023Updated Sep 21, 2017

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

A Phase 3 interventional study of barrier methods and barrier methods in Metrorrhagia, sponsored by Eurofarma Laboratorios S.A.. Withdrawn at 1 site in Brazil. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-21.

Sponsored by Eurofarma Laboratorios S.A. · Phase 3, Interventional, and Treatment

Why this study was withdrawn
Change Company strategy
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Metrorrhagia

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03

In context

Metrorrhagia

95 studies on the registry are indexed under Metrorrhagia; 24 are open to participants now.

Browse Metrorrhagia studies →

Lead sponsor

Eurofarma Laboratorios S.A. is the lead sponsor of 64 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    dienogest 2 mg/ethynilestradiol 30 mcg;

    Drug: barrier methods

  • Active comparator
    Yasmin®

    Drug: barrier methods

Interventions

  • Drugbarrier methods
  • Drugbarrier methods
06

What researchers measure

Primary outcomes

  1. 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 outcomes

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

    Time frame: 2 and 7 cycles (each cycle is 21 days)

07

Study locations

1 site
  • Instituto de Saúde e Bem Estar da Mulher
    Sao Paulo, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01557023
Lead sponsor
Eurofarma Laboratorios S.A.
Responsible party
Sponsor
First posted
Mar 19, 2012
Start date
Jul 1, 2013 (estimated)
Primary completion
Dec 1, 2014 (estimated)
Completion
Dec 1, 2014 (estimated)
Last update
Sep 21, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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