ContraceptionPhase 4NCT00393198
Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia
A Phase 4 study testing Levonorgestrel (Mirena, BAY86-5028) and Cytotec in people with Contraception and Menorrhagia, run by Bayer at 17 sites in 4 countries.
Trial summary
The purpose of this study is to assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use. Read more about this study
- Who is it for?
- Ages 23 to 45 years, women only
- Conditions the study is for
- Contraception, Menorrhagia
- What is being tested?
- Levonorgestrel (Mirena, BAY86-5028) and Cytotec
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 17 sitesin 4 countries
- Study dates
- Oct 2006to Oct 2012
- 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 23 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Woman currently using MIRENA for contraception or menorrhagia with duration use between 4 years 3 months and 4 years 9 months and willingness to continue with the method.
- Normal size uterus at insertion, corresponding to sound measure of 6-10 cm.
- Clinically normal cervical smear result within 12 preceding months or at screening.
- Clinically normal breast examination findings. For patients >/= 40 years at screening, a clinically normal mammography result within 12 preceding months or at screening is required.
Who cannot join
- Menopausal symptoms impairing patient's quality of life or current estrogen therapy for menopausal symptoms.
- Known or suspected pregnancy.
- Any distortion of the uterine cavity, including congenital or acquired uterine anomalies and fibroids distorting the uterine cavity.
- Current or recurrent pelvic inflammatory disease.
- Abnormal uterine bleeding of unknown origin.
- Acute cervicitis or vaginitis not responding to treatment.
- History of, diagnosed or suspected genital or other malignancy (excluding treated squamous cell carcinoma of the skin), and untreated cervical dysplasia.
- Any active acute liver disease or liver tumor.
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
Finland6 sites
Study site
Helsinki, 00100
Study site
Hyvinkää, 05800
Study site
Jyväskylä, 40100
Study site
Kuopio, 70110
Study site
Tampere, 33100
Study site
Turku, 20100
France6 sites
Study site
Brignoles, 83170
Study site
Compiègne, 60204
Study site
Nancy, 54042
Study site
Quetigny, 21800
Study site
Reims, 51100
Study site
Roanne, 42300
Sweden3 sites
Study site
Stockholm, 118 83
Study site
Stockholm, 182 88
Study site
Stockholm, S-171 76
About this study
Official title: Multicenter Study to Investigate the Bleeding Profile and the Insertion Easiness in Women Inserted With a Second Consecutive MIRENA for Contraception or Menorrhagia
The purpose of this study is to assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use.
Read the detailed description
This study has previously been posted by Schering AG, Germany. Schering AG has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
- Conditions
- Contraception, Menorrhagia
- Being tested
- Levonorgestrel (Mirena, BAY86-5028), Cytotec, Placebo
- Keywords
- Intrauterine System, Contraception, Menorrhagia
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel (Mirena, BAY86-5028)Drug
Removal of first MIRENA and insertion of the second MIRENA at entry visit. Removal of MIRENA (in vitro release rate 20 microgram/24h) at year 5 visit.
CytotecDrug
Cytotec, single, sublingual dose of 400 microgram, 3 hours prior to the MIRENA removal and insertion procedure at entry visit
PlaceboDrug
Placebo, single, sublingual dose, 3 hours prior to the MIRENA removal and insertion procedure at entry visit.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Levonorgestrel (Mirena, BAY86-5028) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Cytotec |
| Arm 3 | Active comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy variable will be bleeding profile
Measured: Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5
Secondary outcomes (1)
Secondary efficacy variables will be insertion assessment, continuation rate, pregnancy rate and menstrual comfort and user satisfaction
Measured: Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 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
- NCT00393198
- Sponsor's protocol ID
- 91473
- Other IDs
- 2006-000394-30, 309988
- Status last verified
- Oct 2014
- First submitted
- 26 Oct 2006
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Heikinheimo O, Inki P, Kunz M, Parmhed S, Anttila AM, Olsson SE, Hurskainen R, Gemzell-Danielsson K. Double-blind, randomized, placebo-controlled study on the effect of misoprostol on ease of consecutive insertion of the levonorgestrel-releasing intrauterine system. Contraception. 2010 Jun;81(6):481-6. doi: 10.1016/j.contraception.2010.01.020. Epub 2010 Mar 1.
PubMed 20472114Gemzell-Danielsson K, Inki P, Boubli L, O'Flynn M, Kunz M, Heikinheimo O. Bleeding pattern and safety of consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS)--a multicentre prospective study. Hum Reprod. 2010 Feb;25(2):354-9. doi: 10.1093/humrep/dep426. Epub 2009 Dec 1.
PubMed 19955104Heikinheimo O, Inki P, Kunz M, Gemzell-Danielsson K. Predictors of bleeding and user satisfaction during consecutive use of the levonorgestrel-releasing intrauterine system. Hum Reprod. 2010 Jun;25(6):1423-7. doi: 10.1093/humrep/deq079. Epub 2010 Apr 8.
PubMed 20378611Heikinheimo O, Inki P, Schmelter T, Gemzell-Danielsson K. Bleeding pattern and user satisfaction in second consecutive levonorgestrel-releasing intrauterine system users: results of a prospective 5-year study. Hum Reprod. 2014 Jun;29(6):1182-8. doi: 10.1093/humrep/deu063. Epub 2014 Mar 28.
PubMed 24682613
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study to Investigate the Bleeding Profile and the Insertion Easiness in Women Inserted With a Second Consecutive MIRENA for Contraception or Menorrhagia
- ClinicalTrials.gov ID
- NCT00393198
- Acronym / sponsor ID
- 91473
- Conditions
- Contraception, Menorrhagia
- Keywords
- Intrauterine System, Contraception, Menorrhagia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 27 Oct 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 assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use.
Detailed description
This study has previously been posted by Schering AG, Germany. Schering AG 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
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Levonorgestrel (Mirena, BAY86-5028) |
| Arm 2 | Placebo comparator | Drug: Cytotec |
| Arm 3 | Active comparator | Drug: Placebo |
Who may qualify
- Ages
- 23 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Woman currently using MIRENA for contraception or menorrhagia with duration use between 4 years 3 months and 4 years 9 months and willingness to continue with the method.
- Normal size uterus at insertion, corresponding to sound measure of 6-10 cm.
- Clinically normal cervical smear result within 12 preceding months or at screening.
- Clinically normal breast examination findings. For patients >/= 40 years at screening, a clinically normal mammography result within 12 preceding months or at screening is required.
Key exclusion criteria (8 listed)
- Menopausal symptoms impairing patient's quality of life or current estrogen therapy for menopausal symptoms.
- Known or suspected pregnancy.
- Any distortion of the uterine cavity, including congenital or acquired uterine anomalies and fibroids distorting the uterine cavity.
- Current or recurrent pelvic inflammatory disease.
- Abnormal uterine bleeding of unknown origin.
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 |
|---|---|---|
| Levonorgestrel (Mirena, BAY86-5028)Removal of first MIRENA and insertion of the second MIRENA at entry visit. Removal of MIRENA (in vitro release rate 20 microgram/24h) at year 5 visit. | Drug | Arm 1 |
| CytotecCytotec, single, sublingual dose of 400 microgram, 3 hours prior to the MIRENA removal and insertion procedure at entry visit | Drug | Arm 2 |
| PlaceboPlacebo, single, sublingual dose, 3 hours prior to the MIRENA removal and insertion procedure at entry visit. | Drug | Arm 3 |
Primary outcome
Primary efficacy variable will be bleeding profile
Time frame: Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5
1 secondary outcome
Secondary efficacy variables will be insertion assessment, continuation rate, pregnancy rate and menstrual comfort and user satisfaction
Time frame: Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5
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 Nov 2014.
- Results publication: PubMed 20472114Heikinheimo O, Inki P, Kunz M, Parmhed S, Anttila AM, Olsson SE, Hurskainen R, Gemzell-Danielsson K. Double-blind, randomized, placebo-controlled study on the effect of misoprostol on ease of consecutive insertion of the levonorgestrel-releasing intrauterine system. Contraception. 2010 Jun;81(6):481-6. doi: 10.1016/j.contraception.2010.01.020. Epub 2010 Mar 1.
- Results publication: PubMed 19955104Gemzell-Danielsson K, Inki P, Boubli L, O'Flynn M, Kunz M, Heikinheimo O. Bleeding pattern and safety of consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS)--a multicentre prospective study. Hum Reprod. 2010 Feb;25(2):354-9. doi: 10.1093/humrep/dep426. Epub 2009 Dec 1.
- Results publication: PubMed 20378611Heikinheimo O, Inki P, Kunz M, Gemzell-Danielsson K. Predictors of bleeding and user satisfaction during consecutive use of the levonorgestrel-releasing intrauterine system. Hum Reprod. 2010 Jun;25(6):1423-7. doi: 10.1093/humrep/deq079. Epub 2010 Apr 8.
- Derived from this study: PubMed 24682613Heikinheimo O, Inki P, Schmelter T, Gemzell-Danielsson K. Bleeding pattern and user satisfaction in second consecutive levonorgestrel-releasing intrauterine system users: results of a prospective 5-year study. Hum Reprod. 2014 Jun;29(6):1182-8. doi: 10.1093/humrep/deu063. Epub 2014 Mar 28.
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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
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levonorgestrel (Mirena, BAY86-5028) and Cytotec in people with Contraception and Menorrhagia, run by Bayer at 17 sites in 4 countries.
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 4 inclusion and 8 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 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Finland, France, Sweden, Ireland. 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 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?
Primary efficacy variable will be bleeding profile (time frame: Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00393198, which also lists 4 linked publications.
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 Nov 2014.