ContraceptionPhase 3NCT00185367
Comparative Cycle Control Europe
A Phase 3 study testing EV/DNG (Qlaira, BAY86-5027, SH T00658K) and SH D 593 B (Miranova) in people with Contraception, run by Bayer at 34 sites in 3 countries.
Trial summary
The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- EV/DNG (Qlaira, BAY86-5027, SH T00658K) and SH D 593 B (Miranova)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 798 participants
- Where
- 34 sitesin 3 countries
- Study dates
- Mar 2005to Sep 2006
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female volunteers aged between 18 and 50 years requiring contraception
Who cannot join
- Pregnancy or lactation
- Any conditions that might interfere with the outcome as well as all contraindications for OC use
Trial locations and contacts
34 sites in 3 countries.
34 sites in 3 countries
Germany19 sites
Frauenarztpraxis Hr. Dr. H. Lindecke
Berlin, State of Berlin, 10247
Praxis Fr. Dr. B. Heuberger
Berlin, State of Berlin, 12587
Praxis Hr. Dr. Karl-Heinz Belling
Berlin, State of Berlin, 13086
Frauenarztpraxis Hr. Dr. B. Hamann
Berlin, State of Berlin, 13187
Frauenarztpraxis Dr. Wetzel
Blankenburg, Saxony-Anhalt, 38889
Frauenarztpraxis Dipl. med. Michael Stellmacher
Burg, Saxony-Anhalt, 39288
Praxis Fr. Dr. A. Münzberger
Döbeln, Saxony, 04720
Praxis Fr. Dr. K. Kopprasch
Dresden, Saxony, 01169
Praxis Fr. R. Hellmich
Dresden, Saxony, 01187
Praxis Dr. Larbig
Fulda, Hesse, 36037
Praxis Hr. R. Wähnert
Gera, Thuringia, 07545
Praxis Fr. Dr. J. Schmidt-Pich
Hanover, Lower Saxony, 30159
Praxis Fr. Dr. A.Mönch-Hering
Kahla, Thuringia, 07768
Frauenarztpraxis Dr. Bernd Pittner
Leipzig, Saxony, 04207
Praxis Fr. Dr. C. Burgkhardt
Leipzig, Saxony, 04299
Praxis Fr. Dr. A. Braune
Magdeburg, Saxony-Anhalt, 39104
Praxis Hr. Prof. Dr. H.-J. Ahrendt
Magdeburg, Saxony-Anhalt, 39126
Frauenarztpraxis Dr. Buchberger
Neubiberg, Bavaria, 85579
Praxis Hr. Dr. R. Kuett
Nuremberg, Bavaria, 90491
France10 sites
Dr. Jocelyne Nataf-Maurin
Brignoles, 83170
Dr. Marie-Helene Malbranche-Aupecle
Dijon, 21000
Centre Hospitalier de l Estuaire
Honfleur, 14601
Dr. Annette Mercier
Morlaix, 29600
Clinique d Occitanie
Muret, 31600
Centre Medical du Val de Loire
Nevers, 58000
Dr. Anne-Isabelle Richet
Paris, 75007
Cabinet medical
Quetigny, 21800
Dr. Gwendoline Servan
Tarare, 69170
Dr. Aliette Siboni-Frisch
Toulouse, 31000
Czechia5 sites
Soukroma gynekologicka ambulance
Fulnek, 74245
Soukroma gynekologicka ambulance
Pilsen, 30708
Provozorna Gynekologicka ordinace Dr. Tesar
Prague, 109 00
Femina Sana s.r.o
Prague, 13000
Soukroma gynekologicka ambulance
Zábřeh nad Odrou, 70400
About this study
Official title: A Multi-center, Double-blind, Double-dummy, Controlled, Randomized Study to Evaluate Cycle Control and Safety of a Four Phasic Oral Contraceptive (SH T00658ID) in Comparison to an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D 593 B) in Healthy Female Volunteers Aged Between 18 and 50 Years.
The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.
Read the detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
- Conditions
- Contraception
- Being tested
- EV/DNG (Qlaira, BAY86-5027, SH T00658K), SH D 593 B (Miranova)
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 T00658K)Drug
7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-2: 3.0 mg EV; Day 3-7: 2.0 mg EV + 2.0 mg DNG; Day 8-24: 2.0 mg EV + 3.0 mg DNG; Day 25-26: 1.0 mg EV; Day 27-28: placebo;In addition SH D 593 B (Miranova) matching placebo
SH D 593 B (Miranova)Drug
7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-21: 0.02 mg EE + 0.10 mg LNG; Day 22-28: placebo; In addition EV/DNG (Qlaira, BAY86-5027, SH T00658K) matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K) |
| Arm 2 | Active comparator | Not described Receives: Drug: SH D 593 B (Miranova) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding pattern
Measured: 7 treatment cycles each consisting of 28 days
Number of unintended pregnancies
Measured: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days
Secondary outcomes (1)
Adverse event collection
Measured: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 798 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185367
- Sponsor's protocol ID
- 90883
- Other IDs
- EudraCT: 2004-001613-34, 304004
- Status last verified
- Jul 2011
- First submitted
- 13 Sep 2005
- Last updated
- 15 Jul 2011
- Results posted
- No
Publications
Ahrendt HJ, Makalova D, Parke S, Mellinger U, Mansour D. Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel. Contraception. 2009 Nov;80(5):436-44. doi: 10.1016/j.contraception.2009.03.018. Epub 2009 May 13.
PubMed 19835717
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Double-dummy, Controlled, Randomized Study to Evaluate Cycle Control and Safety of a Four Phasic Oral Contraceptive (SH T00658ID) in Comparison to an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D 593 B) in Healthy Female Volunteers Aged Between 18 and 50 Years.
- ClinicalTrials.gov ID
- NCT00185367
- Acronym / sponsor ID
- 90883
- Conditions
- Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 798 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Sep 2006 (actual)
- First posted
- 16 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 aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K) |
| Arm 2 | Active comparator | Drug: SH D 593 B (Miranova) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy female volunteers aged between 18 and 50 years requiring contraception
Key exclusion criteria (2 listed)
- Pregnancy or lactation
- Any conditions that might interfere with the outcome as well as all contraindications for OC use
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 T00658K)7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-2: 3.0 mg EV; Day 3-7: 2.0 mg EV + 2.0 mg DNG; Day 8-24: 2.0 mg EV + 3.0 mg DNG; Day 25-26: 1.0 mg EV; Day 27-28: placebo;In addition SH D 593 B (Miranova) matching placebo | Drug | Arm 1 |
| SH D 593 B (Miranova)7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-21: 0.02 mg EE + 0.10 mg LNG; Day 22-28: placebo; In addition EV/DNG (Qlaira, BAY86-5027, SH T00658K) matching placebo | Drug | Arm 2 |
Primary outcome
Bleeding pattern
Time frame: 7 treatment cycles each consisting of 28 days
Number of unintended pregnancies
Time frame: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days
1 secondary outcome
Adverse event collection
Time frame: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days
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 15 Jul 2011.
- Derived from this study: PubMed 19835717Ahrendt HJ, Makalova D, Parke S, Mellinger U, Mansour D. Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel. Contraception. 2009 Nov;80(5):436-44. doi: 10.1016/j.contraception.2009.03.018. Epub 2009 May 13.
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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
34 sites in 3 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 T00658K) and SH D 593 B (Miranova) in people with Contraception, run by Bayer at 34 sites in 3 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 2 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 15 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Germany, France, Czechia. 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?
Bleeding pattern (time frame: 7 treatment cycles each consisting of 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00185367, which also lists 1 linked publication.
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 15 Jul 2011.