Oral ContraceptivePhase 3NCT00302666
Bleeding Pattern Study
A Phase 3 study testing Valette (Dienogest/EE30, BAY86-5038) in people with Oral Contraceptive, run by Bayer at 48 sites in Germany.
Trial summary
The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy and safety of this oral contraceptive in two different regimens of intake. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oral Contraceptive
- What is being tested?
- Valette (Dienogest/EE30, BAY86-5038)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,315 participants
- Where
- 48 sitesGermany
- Study dates
- Jun 2003to Feb 2005
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female volunteers aged between 18 and 40 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
48 sites in 1 country.
48 sites in 1 country
Germany48 sites
Study site
Berlin, State of Berlin, 10117
Study site
Berlin, State of Berlin, 10247
Study site
Berlin, State of Berlin, 12587
Study site
Berlin, State of Berlin, 13086
Study site
Berlin, State of Berlin, 13187
Study site
Bernburg, Saxony-Anhalt, 06406
Study site
Blankenburg, Saxony-Anhalt, 38889
Study site
Dietzenbach, Hesse, 63128
Study site
Döbeln, Saxony, 04720
Study site
Dresden, Saxony, 01169
Study site
Dresden, Saxony, 01187
Study site
Eberbach, Baden-Wurttemberg, 69412
Study site
Eisenberg, Thuringia, 07607
Study site
Frankfurt am Main, Hesse, 60322
Study site
Frankfurt am Main, Hesse, 60596
Study site
Frankfurt am Main, Hesse, 65936
Study site
Fulda, Hesse, 36037
Study site
Gera, Thuringia, 07545
Study site
Gevelsberg, North Rhine-Westphalia, 58285
Study site
Gütersloh, North Rhine-Westphalia, 33330
Study site
Hamburg, Free and Hanseatic City of Hamburg, 21073
Study site
Hamburg, Free and Hanseatic City of Hamburg, 22041
Study site
Hanover, Lower Saxony, 30159
Study site
Hanover, Lower Saxony, 30459
Study site
Höchstadt A. D. Aisch, Bavaria, 91315
Study site
Jena, Thuringia, 07747
Study site
Jessen, Saxony-Anhalt, 06917
Study site
Kahla, Thuringia, 07768
Study site
Kelkheim, Hesse, 65779
Study site
Kirchheimbolanden, Rhineland-Palatinate, 67292
Study site
Krumbach, Bavaria, 86381
Study site
Langen, Hesse, 63225
Study site
Leipzig, Saxony, 04207
Study site
Leipzig, Saxony, 04299
Study site
Leipzig, Saxony, 04315
Study site
Magdeburg, Saxony-Anhalt, 39104
Study site
Magdeburg, Saxony-Anhalt, 39108
Study site
Magdeburg, Saxony-Anhalt, 39118
Study site
Magdeburg, Saxony-Anhalt, 39126
Study site
Magdeburg, Saxony-Anhalt, 39130
Study site
Mühlheim am Main, Hesse, 63165
Study site
Neubiberg, Bavaria, 85579
Study site
Neustrelitz, Mecklenburg-Vorpommern, 17235
Study site
Nuremberg, Bavaria, 90491
Study site
Ronnenberg, Lower Saxony, 30952
Study site
Saalfeld, Thuringia, 07318
Study site
Speyer, Rhineland-Palatinate, 67346
Study site
Wurzen, Saxony, 04808
About this study
Official title: Comparative, Prospective, Multi-Center, Open, Randomized Study to Investigate Bleeding Patterns, Metabolic Effects, Contraceptive Efficacy, Acceptance, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 2 mg Dienogest, in Two Different Regimens of Intake (Four Extended Cycles of 84 Days Each Versus the Conventional Regimen of 21 Days) in Healthy Volunteers
The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy and safety of this oral contraceptive in two different regimens of intake.
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
- Oral Contraceptive
- Being tested
- Valette (Dienogest/EE30, BAY86-5038)
- Keywords
- Contraception, Bleeding pattern
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valette (Dienogest/EE30, BAY86-5038)Drug
Oral contraceptive extended cycles
Valette (Dienogest/EE30, BAY86-5038)Drug
Oral contraceptive conventional cycles
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Sham comparator | Not described Receives: Drug: Valette (Dienogest/EE30, BAY86-5038) |
| Arm 2 | Sham comparator | Not described Receives: Drug: Valette (Dienogest/EE30, BAY86-5038) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding pattern
Secondary outcomes (1)
Safety, contraceptive efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startJun 2003
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral ContraceptiveStudies 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
- None (open label)
- Enrolment
- 1,315 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
- NCT00302666
- Sponsor's protocol ID
- 91227
- Other IDs
- 306903
- Status last verified
- May 2009
- First submitted
- 23 Feb 2006
- Last updated
- 18 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Prospective, Multi-Center, Open, Randomized Study to Investigate Bleeding Patterns, Metabolic Effects, Contraceptive Efficacy, Acceptance, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 2 mg Dienogest, in Two Different Regimens of Intake (Four Extended Cycles of 84 Days Each Versus the Conventional Regimen of 21 Days) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00302666
- Acronym / sponsor ID
- 91227
- Conditions
- Oral Contraceptive
- Keywords
- Contraception, Bleeding pattern
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,315 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Feb 2005 (actual)
- First posted
- 14 Mar 2006 (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, contraceptive efficacy and safety of this oral contraceptive in two different regimens of intake.
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
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Sham comparator | Drug: Valette (Dienogest/EE30, BAY86-5038) |
| Arm 2 | Sham comparator | Drug: Valette (Dienogest/EE30, BAY86-5038) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy female volunteers aged between 18 and 40 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 |
|---|---|---|
| Valette (Dienogest/EE30, BAY86-5038)Oral contraceptive extended cycles | Drug | Arm 1 |
| Valette (Dienogest/EE30, BAY86-5038)Oral contraceptive conventional cycles | Drug | Arm 2 |
Primary outcome
Bleeding pattern
1 secondary outcome
Safety, contraceptive efficacy
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 18 May 2009.
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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
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valette (Dienogest/EE30, BAY86-5038) in people with Oral Contraceptive, run by Bayer at 48 sites in Germany.
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 18 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Germany. 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. Some participants in this study may receive a placebo. 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. 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 18 May 2009; AzTrials last refreshed its copy on 27 Oct 2026.