MetrorrhagiaPhase 3NCT01557023
Clinical Trial With Combination of Dienogest/Ethytnilestradiol and Drosperidona/Ethyniestradiol
A Phase 3 study testing barrier methods in people with Metrorrhagia, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metrorrhagia
- What is being tested?
- barrier methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2013to 1 Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- barrier methods
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
barrier methodsDrug
barrier methodsDrug
| Study group | Role | What they receive |
|---|---|---|
| dienogest 2 mg/ethynilestradiol 30 mcg; | Experimental | Not described Receives: Drug: barrier methods |
| Yasmin® | Active comparator | Not described Receives: Drug: barrier methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of intracyclic bleeding and/or spotting during the cycles 2 and 3 of treatment
Measured: 2 and 3 cycles (each cycle is 21 days)
Secondary outcomes (1)
Percentage of women with intracyclic bleeding during treatment cycles 2 to 7
Measured: 2 and 7 cycles (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study start1 Jul 2013 (estimated)
- Primary completion1 Dec 2014 (estimated)
- Study completion1 Dec 2014 (estimated)
Why it stopped: Change Company strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetrorrhagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557023
- Sponsor's protocol ID
- EF 124 NINA
- Status last verified
- Mar 2012
- First submitted
- 8 Mar 2012
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial With Combination of Dienogest/Ethytnilestradiol and Drosperidona/Ethyniestradiol
- ClinicalTrials.gov ID
- NCT01557023
- Acronym / sponsor ID
- EF 124 NINA
- Conditions
- Metrorrhagia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change Company strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2013 (estimated)
- Primary completion
- 1 Dec 2014 (estimated)
- Study completion
- 1 Dec 2014 (estimated)
- First posted
- 19 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dienogest 2 mg/ethynilestradiol 30 mcg; | Experimental | Drug: barrier methods |
| Yasmin® | Active comparator | Drug: barrier methods |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| barrier methods | Drug | dienogest 2 mg/ethynilestradiol 30 mcg; |
| barrier methods | Drug | Yasmin® |
Primary outcome
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)
1 secondary outcome
Percentage of women with intracyclic bleeding during treatment cycles 2 to 7
Time frame: 2 and 7 cycles (each cycle is 21 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing barrier methods in people with Metrorrhagia, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2017.