ContraceptionCOSMENCT00988910
Effects of Drospirenone-containing or -Not Containing Combined Oral Contraceptives on General and Sexual Well-being
An observational study of Contraception, run by Bayer at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the symptoms and satisfaction for women taking drospirenone (DRSP)-containing combined oral contraceptives in comparison with women taking other kind of combined oral contraceptives. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- EE30-DRSP (Yasmin, BAY86-5131) and Other combined oral contraceptives
- Type of treatment
- Pill or oral medicine
- How many people
- 632 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2008to Dec 2010
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women using Combined Oral Contraceptive (COC)
Who may be able to join
- According to the label of the prescribed Combined Oral Contraceptive (COC)
- first Combined Oral Contraceptive use or previous Combined Oral Contraceptive use
- intention to use current COC for 1 year at least
Who cannot join
- Contraindications listed in the label of the prescribed Combined Oral Contraceptive (COC)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on the Effects of DRSP-Containing Combined Oral Contraceptives (Yasmin,Yasminelle) and Other Combined Oral Contraceptives on the General and Sexual Well-Being in COC Users
The purpose of this study is to evaluate the symptoms and satisfaction for women taking drospirenone (DRSP)-containing combined oral contraceptives in comparison with women taking other kind of combined oral contraceptives.
- Conditions
- Contraception
- Being tested
- EE30-DRSP (Yasmin, BAY86-5131), Other combined oral contraceptives
- Keywords
- Combined Oral Contraceptives, COC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EE30-DRSP (Yasmin, BAY86-5131)Drug
DRSP-containing combined oral contraceptives according to the normal routine praxis
Other combined oral contraceptivesDrug
Other combined oral contraceptives according to the normal routine praxis
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: EE30-DRSP (Yasmin, BAY86-5131) | |
| Group 2 | Not described Receives: Drug: Other combined oral contraceptives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychophysical well-being evaluated by the Psychological General Well-Being Index (PGWBI)
Measured: at 12 months
Sexual well-being evaluated by the Female Sexual Function Index (FSFI)
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2009
- Study completionDec 2010
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 632 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
- NCT00988910
- Sponsor's protocol ID
- 14182
- Other IDs
- YA0711IT
- Acronym
- COSME
- Status last verified
- Jun 2014
- First submitted
- 1 Oct 2009
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Effects of DRSP-Containing Combined Oral Contraceptives (Yasmin,Yasminelle) and Other Combined Oral Contraceptives on the General and Sexual Well-Being in COC Users
- ClinicalTrials.gov ID
- NCT00988910
- Acronym / sponsor ID
- COSME / 14182
- Conditions
- Contraception
- Keywords
- Combined Oral Contraceptives, COC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 632 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Oct 2009 (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 symptoms and satisfaction for women taking drospirenone (DRSP)-containing combined oral contraceptives in comparison with women taking other kind of combined oral contraceptives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: EE30-DRSP (Yasmin, BAY86-5131) |
| Group 2 | – | Drug: Other combined oral contraceptives |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women using Combined Oral Contraceptive (COC)
Key inclusion criteria (3 listed)
- According to the label of the prescribed Combined Oral Contraceptive (COC)
- first Combined Oral Contraceptive use or previous Combined Oral Contraceptive use
- intention to use current COC for 1 year at least
Key exclusion criteria (1 listed)
- Contraindications listed in the label of the prescribed Combined Oral Contraceptive (COC)
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 |
|---|---|---|
| EE30-DRSP (Yasmin, BAY86-5131)DRSP-containing combined oral contraceptives according to the normal routine praxis | Drug | Group 1 |
| Other combined oral contraceptivesOther combined oral contraceptives according to the normal routine praxis | Drug | Group 2 |
Primary outcome
Psychophysical well-being evaluated by the Psychological General Well-Being Index (PGWBI)
Time frame: at 12 months
Sexual well-being evaluated by the Female Sexual Function Index (FSFI)
Time frame: at 12 months
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 26 Jun 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Bayer at 1 site in Italy.
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 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
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?
Psychophysical well-being evaluated by the Psychological General Well-Being Index (PGWBI) (time frame: at 12 months). 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?
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 26 Jun 2014.