ContraceptionPhase 4NCT00498784
HR-QoL and Sexuality in Mirena Inserted Contraception Users
A Phase 4 study testing Mirena in people with Contraception, run by Bayer at 1 site in France.
Trial summary
The purpose of this study is to evaluate the changes in the quality of life, as well as in the sexual activity, in women inserted with MIRENA, a hormonal contraceptive intra-uterine system, over the first 12 months of use. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Mirena
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2005to Oct 2007
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy woman willing to, or having to switch from her OC to another contraceptive method
Who cannot join
- Any contraindication to Mirena insertion/use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open Labelled, Uncontrolled, Phase IV Clinical Study to Evaluate the Health-related Quality of Life and Sexual Well-being in Young (18-35) Healthy Mirena Users Switching From OC, Over the First Year Post-insertion.
The purpose of this study is to evaluate the changes in the quality of life, as well as in the sexual activity, in women inserted with MIRENA, a hormonal contraceptive intra-uterine system, over the first 12 months of use. Patients switching from oral contraception to an intrauterine contraceptive device (here: MIRENA) will be observed in the first year post MIRENA insertion.
- Conditions
- Contraception
- Being tested
- Mirena
- Keywords
- Intra-uterine contraception, Intrauterine Devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirenaDrug
Mirena 52mg during 1 year
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Mirena |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related QoL score
Measured: 1 year
Secondary outcomes (1)
Sexuality Index, treatment satisfaction, usual safety outcomes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2007 (estimated)
- Study startNov 2005
- Primary completionOct 2007
- Study completionOct 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 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
- NCT00498784
- Sponsor's protocol ID
- 91458
- Other IDs
- 2005-002955-42, 309663, 2005
- Status last verified
- Jan 2013
- First submitted
- 9 Jul 2007
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Labelled, Uncontrolled, Phase IV Clinical Study to Evaluate the Health-related Quality of Life and Sexual Well-being in Young (18-35) Healthy Mirena Users Switching From OC, Over the First Year Post-insertion.
- ClinicalTrials.gov ID
- NCT00498784
- Acronym / sponsor ID
- 91458
- Conditions
- Contraception
- Keywords
- Intra-uterine contraception, Intrauterine Devices
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 10 Jul 2007 (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 changes in the quality of life, as well as in the sexual activity, in women inserted with MIRENA, a hormonal contraceptive intra-uterine system, over the first 12 months of use. Patients switching from oral contraception to an intrauterine contraceptive device (here: MIRENA) will be observed in the first year post MIRENA insertion.
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: Mirena |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy woman willing to, or having to switch from her OC to another contraceptive method
Key exclusion criteria (1 listed)
- Any contraindication to Mirena insertion/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 |
|---|---|---|
| MirenaMirena 52mg during 1 year | Drug | Arm 1 |
Primary outcome
Health-related QoL score
Time frame: 1 year
1 secondary outcome
Sexuality Index, treatment satisfaction, usual safety outcomes
Time frame: 1 year
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 23 Jan 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirena in people with Contraception, run by Bayer at 1 site in France.
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 23 Jan 2013. 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 France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Health-related QoL score (time frame: 1 year). 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 23 Jan 2013.