ContraceptionPhase 3NCT00220324
Pearl Index Study With Low Dose Combined Oral Contraceptive
A Phase 3 study testing Minisiston (SH D00342A) in people with Contraception, run by Bayer at 25 sites in Germany.
Trial summary
The purpose of this study is to investigate the contraceptive efficacy, bleeding pattern, and safety of SH D00342A. Subjects participating in the study will be treated with an oral contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel. 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
- Contraception
- What is being tested?
- Minisiston (SH D00342A)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 25 sitesGermany
- Study dates
- Feb 2004to Nov 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 women requiring contraception
Who cannot join
- Pregnant or lactating women, history or suspicion of hormone dependent tumor or any other conditions which forbid the participation.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Germany25 sites
Study site
Aschersleben, Saxony-Anhalt, 06449
Study site
Berlin, State of Berlin, 10179
Study site
Berlin, State of Berlin, 10247
Study site
Berlin, State of Berlin, 10409
Study site
Berlin, State of Berlin, 12435
Study site
Berlin, State of Berlin, 13507
Study site
Burg, Saxony-Anhalt, 39288
Study site
Dresden, Saxony, 01067
Study site
Dresden, Saxony, 01099
Study site
Dresden, Saxony, 01108
Study site
Dresden, Saxony, 01324
Study site
Egeln, Saxony-Anhalt, 39435
Study site
Großpösna, Saxony, 04463
Study site
Halberstadt, Saxony-Anhalt, 38820
Study site
Halberstadt, Saxony-Anhalt, 38821
Study site
Hanover, Lower Saxony, 30159
Study site
Jessen, Saxony-Anhalt, 06917
Study site
Leipzig, Saxony, 04207
Study site
Leipzig, Saxony, 04277
Study site
Leipzig, Saxony, 04279
Study site
Magdeburg, Saxony-Anhalt, 39112
Study site
Magdeburg, Saxony-Anhalt, 39120
Study site
Magdeburg, Saxony-Anhalt, 39126
Study site
Suhl, Thuringia, 98527
Study site
Weida, Thuringia, 07579
About this study
Official title: Prospective, Multicenter, Open-label, Uncontrolled Study to Investigate the Contraceptive Efficacy, Bleeding Patterns, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 0.125 mg Levonorgestrel (SH D00342A) Applied for 13 Cycles to Healthy Female Volunteers
The purpose of this study is to investigate the contraceptive efficacy, bleeding pattern, and safety of SH D00342A. Subjects participating in the study will be treated with an oral contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel.
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
- Minisiston (SH D00342A)
- Keywords
- Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minisiston (SH D00342A)Drug
Daily oral administration in 21 days per cycle, followed by a 7-day pill-free interval
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Minisiston (SH D00342A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unadjusted Pearl Index
Measured: After 13 cycles of intake
Secondary outcomes (4)
Adjusted Pearl Index
Measured: After 13 cycles of intake
Cumulative pregnancy rate
Measured: After 13 cycles of intake
Bleeding pattern
Measured: After 13 cycles of intake
Cycle control
Measured: After 13 cycles of intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startFeb 2004
- Study completionNov 2005
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
- 840 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
- NCT00220324
- Sponsor's protocol ID
- 91313
- Other IDs
- 307987
- Status last verified
- Apr 2015
- First submitted
- 16 Sep 2005
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Open-label, Uncontrolled Study to Investigate the Contraceptive Efficacy, Bleeding Patterns, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 0.125 mg Levonorgestrel (SH D00342A) Applied for 13 Cycles to Healthy Female Volunteers
- ClinicalTrials.gov ID
- NCT00220324
- Acronym / sponsor ID
- 91313
- Conditions
- Contraception
- Keywords
- Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Study completion
- Nov 2005 (actual)
- First posted
- 22 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 investigate the contraceptive efficacy, bleeding pattern, and safety of SH D00342A. Subjects participating in the study will be treated with an oral contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Minisiston (SH D00342A) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy women requiring contraception
Key exclusion criteria (1 listed)
- Pregnant or lactating women, history or suspicion of hormone dependent tumor or any other conditions which forbid the participation.
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 |
|---|---|---|
| Minisiston (SH D00342A)Daily oral administration in 21 days per cycle, followed by a 7-day pill-free interval | Drug | Arm 1 |
Primary outcome
Unadjusted Pearl Index
Time frame: After 13 cycles of intake
4 secondary outcomes
Adjusted Pearl Index
Time frame: After 13 cycles of intake
Cumulative pregnancy rate
Time frame: After 13 cycles of intake
Bleeding pattern
Time frame: After 13 cycles of intake
Cycle control
Time frame: After 13 cycles of intake
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 3 Apr 2015.
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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
25 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 Minisiston (SH D00342A) in people with Contraception, run by Bayer at 25 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 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 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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. 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?
Unadjusted Pearl Index (time frame: After 13 cycles of intake). 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 3 Apr 2015.