NulliparousNCT00798980

Scandinavian Mirena Insertion Nulliparous Trial.

An observational study of Nulliparous, run by Bayer at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

In this non-interventional study we investigate the nulliparous women individual evaluation of the insertion procedure of LNG-IUD and the follow-up period of 3 months post insertion. Read more about this study

Who is it for?: Ages 14 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Nulliparous
What is being tested?: Mirena (BAY86-5028)
How many people: 224 participants
Where: 1 siteSweden
Study dates: Feb 2007to Nov 2009
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 14 years and older
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Primary Care Clinic Patients

Who may be able to join

Nulliparous women Mirena insertion planned as contraceptive method

Who cannot join

Ongoing or suspected pregnancy;
Ongoing or recidivating genital infection;
Cervicitis;
Cervical dysplasia;
Malignancy in uterus or cervix;
Confirmed or suspected hormone sensitive neoplasia including breast cancer

Show all 11Show fewer

Undiagnosed abnormal uterine bleeding;
Uterine anomaly including myoma if the cavity of the uterus is restricted;
Conditions that cause increased risk of infections;
Acute liver disease or liver tumour;
Allergy to the active substance or any component of the IUD

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Study site
Many Locations

Other trials in Sweden

About this study

Official title: Scandinavian Mirena Insertion Nulliparous Trial of an Observational Study.

In this non-interventional study we investigate the nulliparous women individual evaluation of the insertion procedure of LNG-IUD and the follow-up period of 3 months post insertion.

Conditions: Nulliparous
Being tested: Mirena (BAY86-5028)
Keywords: Mirena, Nulliparous, Intrauterine Devices

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mirena (BAY86-5028)Drug
Nulliparous Women

Study groups in NCT00798980
Study group	Role	What they receive
Arm 1		Not described Receives: Drug: Mirena (BAY86-5028)

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of the insertion procedure of Mirena in nulliparous women
Measured: At the insertion time point

Secondary outcomes (4)

Pain
Measured: At the insertion time point
Continuation rate
Measured: 12-16 weeks post insertion
Bleeding Pattern
Measured: 12-16 weeks post insertion
Satisfaction
Measured: 12-16 weeks post insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Nov 2009

First posted27 Nov 2008 (estimated)
Study startFeb 2007
Primary completionJun 2008
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for NulliparousStudies 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: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00798980
Sponsor's protocol ID: 14015
Other IDs: MA0710SE, SCAN 68/06, 2006/0601120
Status last verified: Apr 2015
First submitted: 26 Nov 2008
Last updated: 22 Apr 2015
Results posted: No
Data monitoring committee: No

Publications

Marions L, Lovkvist L, Taube A, Johansson M, Dalvik H, Overlie I. Use of the levonorgestrel releasing-intrauterine system in nulliparous women--a non-interventional study in Sweden. Eur J Contracept Reprod Health Care. 2011 Apr;16(2):126-34. doi: 10.3109/13625187.2011.558222.
PubMed 21417562

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Pelvic Floor Muscle Training During Pregnancy
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Effects of a Multimodal and Multidimensional Intervention on Urinary Incontinence in Young Nulliparous Female Athletes.
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Not yet recruiting
Changes in the Angle of Uterine Flexion as the Bladder Fills
Uterine Anteflexion
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Ripening Approaches for Prompt Induction and Delivery - Sequential Versus Concurrent Dilapan-S and Misoprostol to Achieve Vaginal Delivery (RAPID-DS)
Nulliparous Women Who Scheduled for Labor Induction, Pregnancy
Not yet recruitingObservational study
Prediction of Labor Induction Outcome in Nulliparous Women
Nulliparous Patient With Unfavourable Cervix, Undergoing Labor Induction at Term ≥ 39SA

All Nulliparous trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Scandinavian Mirena Insertion Nulliparous Trial of an Observational Study.
ClinicalTrials.gov ID: NCT00798980
Acronym / sponsor ID: 14015
Conditions: Nulliparous
Keywords: Mirena, Nulliparous, Intrauterine Devices
Study type: Observational
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Jun 2008 (actual)
Study completion: Nov 2009 (actual)
First posted: 27 Nov 2008 (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.

In this non-interventional study we investigate the nulliparous women individual evaluation of the insertion procedure of LNG-IUD and the follow-up period of 3 months post insertion.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Arm 1	–	Drug: Mirena (BAY86-5028)

Who may qualify

Ages: 14 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Primary Care Clinic Patients

Key inclusion criteria (1 listed)

Nulliparous women Mirena insertion planned as contraceptive method

Key exclusion criteria (11 listed)

Ongoing or suspected pregnancy;
Ongoing or recidivating genital infection;
Cervicitis;
Cervical dysplasia;
Malignancy in uterus or cervix;

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
Mirena (BAY86-5028)Nulliparous Women	Drug	Arm 1

Primary outcome

Evaluation of the insertion procedure of Mirena in nulliparous women
Time frame: At the insertion time point

4 secondary outcomes

Pain
Time frame: At the insertion time point
Continuation rate
Time frame: 12-16 weeks post insertion
Bleeding Pattern
Time frame: 12-16 weeks post insertion
Satisfaction
Time frame: 12-16 weeks post insertion

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 22 Apr 2015.
Results publication: PubMed 21417562Marions L, Lovkvist L, Taube A, Johansson M, Dalvik H, Overlie I. Use of the levonorgestrel releasing-intrauterine system in nulliparous women--a non-interventional study in Sweden. Eur J Contracept Reprod Health Care. 2011 Apr;16(2):126-34. doi: 10.3109/13625187.2011.558222.

Related trials for Nulliparous

Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Recruiting
Effects of a Multimodal and Multidimensional Intervention on Urinary Incontinence in Young Nulliparous Female Athletes.
Urinary Incontinence
Not yet recruiting
Changes in the Angle of Uterine Flexion as the Bladder Fills
Uterine Anteflexion
Recruiting
Ripening Approaches for Prompt Induction and Delivery - Sequential Versus Concurrent Dilapan-S and Misoprostol to Achieve Vaginal Delivery (RAPID-DS)
Nulliparous Women Who Scheduled for Labor Induction, Pregnancy
Not yet recruitingObservational study
Prediction of Labor Induction Outcome in Nulliparous Women
Nulliparous Patient With Unfavourable Cervix, Undergoing Labor Induction at Term ≥ 39SA

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 Nulliparous, run by Bayer at 1 site in Sweden.

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 11 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 22 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 1 site in Sweden. 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?

Evaluation of the insertion procedure of Mirena in nulliparous women (time frame: At the insertion time point). 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 NCT00798980, which also lists 1 linked publication.

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 22 Apr 2015.