ContraceptionPhase 3NCT00206583
Efficacy and Safety Study of an Oral Contraceptive in Healthy Females
A Phase 3 study testing EV/DNG (Qlaira, BAY86-5027, SH T00658ID) in people with Contraception, run by Bayer at 29 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether the study drug is safe and effective in the prevention of pregnancies in a large group of volunteers. 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
- Contraception
- What is being tested?
- EV/DNG (Qlaira, BAY86-5027, SH T00658ID)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 499 participants
- Where
- 29 sitesin 2 countries
- Study dates
- Mar 2005to Jul 2007
- 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
- Healthy women between the ages of 18 and 35 years requiring contraception
Who cannot join
- Pregnancy, lactation, and contraindication of combined oral contraceptive
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States20 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Clinical Trial Center of Colorado
Castle Rock, Colorado, 80108
Physicians Research Group
Indianapolis, Indiana, 46250
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, 68510
Women and Children's Hospital, Los Angeles
Los Angeles, California, 90033
OB/GYN Health Center
Medford, Oregon, 97504
New Age Medical Research Corp.
Miami, Florida, 33186
Women's Care Source
Morristown, New Jersey, 07960
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Visions Clinical Research
Palm Springs, Florida, 33461
Lifespan Research
Palo Alto, California, 94301
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, 15213-2582
Oregon Health and Science University
Portland, Oregon, 97239
Genesis Center for Clinical Research
San Diego, California, 92103
Medical Center for Clinical Research
San Diego, California, 92108
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, 98105
Insignia Care for Women, P.A.
Tampa, Florida, 33607
Harbor - UCLA Medical Center
Torrance, California, 90509
Comprehensive Clinical Trials
West Palm Beach, Florida, 33409
Canada9 sites
Rhodin Recherche Clinique
Drummondville, Quebec, J2B 1H8
Total Concept Health Care Inc.
Kitchener, Ontario, N2C 2N9
Centre d'étude clinique de Montréal Inc.
Montreal, Quebec, H1T 1P6
Les Gynecologues Associes
Montreal, Quebec, H2X 1N8
Clinique Recherche en Sante des Femmes Inc.
Québec, Quebec, G1S 2L6
Clinique de Gynecologie
Shawinigan, Quebec, G9N 2H6
Diex Recherche Inc.
Sherbrooke, Quebec, J1H 1Z1
Clinique Médicale des Campus
Ste-Foy, Quebec, G1V 4X7
Temple Green Clinic
Waterloo, Ontario, N2L 6H6
About this study
Official title: A Multicenter, Open-label Uncontrolled Study to Investigate the Efficacy and Safety of a 4-phasic Oral Contraceptive SH T0065 in a 28-day Regimen for 13 Cycles in Healthy Female Subjects
The purpose of this study is to determine whether the study drug is safe and effective in the prevention of pregnancies in a large group of volunteers.
Read the detailed description
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals Inc.. Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the trial.
- Conditions
- Contraception
- Being tested
- EV/DNG (Qlaira, BAY86-5027, SH T00658ID)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV/DNG (Qlaira, BAY86-5027, SH T00658ID)Drug
GA: Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) Tablet, p.o. (oral)
| Study group | Role | What they receive |
|---|---|---|
| EV/DNG (Qlaira, BAY86-5027) | Experimental | Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) Receives: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of unintended pregnancies after 1 year
Measured: Throughout 1 year of treatment
Secondary outcomes (1)
Bleeding pattern and cycle control parameters after 1 year
Measured: Throughout 1 year of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionJun 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206583
- Sponsor's protocol ID
- 90959
- Other IDs
- 304742
- Status last verified
- Sep 2014
- First submitted
- 12 Sep 2005
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Uncontrolled Study to Investigate the Efficacy and Safety of a 4-phasic Oral Contraceptive SH T0065 in a 28-day Regimen for 13 Cycles in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT00206583
- Acronym / sponsor ID
- 90959
- Conditions
- Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 21 Sep 2005 (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.
The purpose of this study is to determine whether the study drug is safe and effective in the prevention of pregnancies in a large group of volunteers.
Detailed description
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals Inc.. Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EV/DNG (Qlaira, BAY86-5027) | Experimental | Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy women between the ages of 18 and 35 years requiring contraception
Key exclusion criteria (1 listed)
- Pregnancy, lactation, and contraindication of combined oral contraceptive
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 |
|---|---|---|
| EV/DNG (Qlaira, BAY86-5027, SH T00658ID)GA: Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) Tablet, p.o. (oral) | Drug | EV/DNG (Qlaira, BAY86-5027) |
Primary outcome
Number of unintended pregnancies after 1 year
Time frame: Throughout 1 year of treatment
1 secondary outcome
Bleeding pattern and cycle control parameters after 1 year
Time frame: Throughout 1 year of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
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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.
Bayer Study Director study director
Bayer
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EV/DNG (Qlaira, BAY86-5027, SH T00658ID) in people with Contraception, run by Bayer at 29 sites in 2 countries.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of unintended pregnancies after 1 year (time frame: Throughout 1 year of treatment). 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 1 Oct 2014.