HealthyPhase 3NCT00367276
Study to Evaluate the Effect of Six Cycles of Treatment With a Combined Oral Contraceptive (EE 0.30 mg/DRSP 3 mg) on Quality of Life.
A Phase 3 study testing Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131) in people with Healthy, run by Bayer.
Trial summary
The purpose of this study is to evaluate the effects on the quality of life and BMI of new contraceptives. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Healthy
- What is being tested?
- Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to May 2004
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Female requiring contraceptives.
- Aged 18 to 35 if a non-smoker, aged 18 to 30 if a smoker.
- Regular menstrual cycle (defined as duration of 28 +/- 5 days).
Who cannot join
- No Contraindication for OC use
About this study
Official title: A Multicentre, Open, Uncontrolled Study to Assess Quality of Life During Six Cycles (24 Weeks) of Treatment With an Oral Contraceptive Containing 30 µg of Ethinylestradiol and 3 mg of Drospirenone (Yasmin).
The purpose of this study is to evaluate the effects on the quality of life and BMI of new contraceptives.
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
- Healthy
- Being tested
- Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)
- Keywords
- Females requiring contraceptives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)Drug
Yasmin, SH T 470 FA; 30 µg ethinylestradiol and 3 mg drospirenone, oral administration over 6 treatment cycles, one tablet per day for 21 days followed by a 7 day pill-free interval.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Psychological General Well Being Questionnaire score
Measured: pretreatment cycle to cycle 6
Secondary outcomes (3)
Changes in body composition (evaluated by Multifrequency Bioelectrical Impedance Analysis)
Measured: pretreatment to cycle 6
Subject satisfaction with treatment at final visit
Measured: at final visit
Subject evaluation of changes in greasy skin and greasy hair
Measured: baseline to cycle 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startDec 2002
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 221 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
- NCT00367276
- Sponsor's protocol ID
- 91070
- Other IDs
- 305545
- Status last verified
- Oct 2013
- First submitted
- 11 Aug 2006
- Last updated
- 11 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open, Uncontrolled Study to Assess Quality of Life During Six Cycles (24 Weeks) of Treatment With an Oral Contraceptive Containing 30 µg of Ethinylestradiol and 3 mg of Drospirenone (Yasmin).
- ClinicalTrials.gov ID
- NCT00367276
- Acronym / sponsor ID
- 91070
- Conditions
- Healthy
- Keywords
- Females requiring contraceptives
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Study completion
- May 2004 (actual)
- First posted
- 22 Aug 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 purpose of this study is to evaluate the effects on the quality of life and BMI of new contraceptives.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female requiring contraceptives.
- Aged 18 to 35 if a non-smoker, aged 18 to 30 if a smoker.
- Regular menstrual cycle (defined as duration of 28 +/- 5 days).
Key exclusion criteria (1 listed)
- No Contraindication 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 |
|---|---|---|
| Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)Yasmin, SH T 470 FA; 30 µg ethinylestradiol and 3 mg drospirenone, oral administration over 6 treatment cycles, one tablet per day for 21 days followed by a 7 day pill-free interval. | Drug | Arm 1 |
Primary outcome
Change of Psychological General Well Being Questionnaire score
Time frame: pretreatment cycle to cycle 6
3 secondary outcomes
Changes in body composition (evaluated by Multifrequency Bioelectrical Impedance Analysis)
Time frame: pretreatment to cycle 6
Subject satisfaction with treatment at final visit
Time frame: at final visit
Subject evaluation of changes in greasy skin and greasy hair
Time frame: baseline to cycle 6
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 11 Oct 2013.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131) in people with Healthy, run by Bayer.
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 3 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 11 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Change of Psychological General Well Being Questionnaire score (time frame: pretreatment cycle to cycle 6). 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 11 Oct 2013.