Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, MirenaPhase 2MiMiNCT01931657
Pretreatment With Mifepristone Prior to Mirena Insertion
A Phase 2 study testing Mifepristone prior to Mirena in people with Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, Mirena, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Hypothesis: Pretreatment with mifeprsitone prior to Mirena placement will induce amenorrhea and reduce bleeding irrregularities during the initial months of Mirena use. 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
- Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, Mirena
- What is being tested?
- Mifepristone prior to Mirena
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2013to Dec 2015
- Phase
- Phase 2
- 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
Who may be able to join
- Pre-menopausal women, >/= 18 years of age.
- Desire of Mirena for contraception
- Good general health (as judged by; general physical examination
- Willing and able to participate after giving informed consent
Who cannot join
- Any hormonal treatment or IUD use within 2 months prior to study start
- History of malignant disorder of the breast
- Any contraindication to mifepristone
- Pregnancy or breast feeding within 2 months prior to study start
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-treatment With Mifepristone in Patients With Mirena for Optimizing Bleeding Pattern in Pre-menopausal Women
Hypothesis: Pretreatment with mifeprsitone prior to Mirena placement will induce amenorrhea and reduce bleeding irrregularities during the initial months of Mirena use.
Read the detailed description
The levonorgestrel releasing intrauterine system (IUS), Mirena, represents a highly effective contraceptive method that is cost-effective and requires limited patient effort. Furthermore Mirena offers numerous noncontraceptive benefits and addresses different medical needs for women in reproductive and non reproductive age. Side effects such as menstrual abnormalities are important reasons for early discontinuation of a contraceptive method. Irregular bleeding pattern and spotting represents a well known adverse effect during the first months of use with Mirena and corresponds to the most important factor that negatively influences the acceptability of the IUS. Up to today no standard treatment has been suggested to resolve this issue.
By inducing amenorrhea within a short period of treatment with an anti-progesterone, mifepristone, prior to insertion of Mirena, the bleeding irregularities during the first months of use might be reduced and could therefore represent an important strategy for increasing acceptability of this contraceptive system.
The purpose of the present study is to evaluate the bleeding pattern during the first months of use of Mirena in patients treated with mifepristone compared to placebo in women using Mirena for contraception. The study will also address the effect of mifepristone on endometrial morphology and breast tissue.
- Being tested
- Mifepristone prior to Mirena, Placebo prior to Mirena insertion
- Keywords
- LNG-IUS, Mirena, Contraception, Bleeding, Hormonal effects in the breast
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone prior to MirenaDrug
Also called Mifepristone
Placebo prior to Mirena insertionDrug
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone prior to Mirena | Experimental | Pretreatment with mifepristone prior to Mirena insertion Receives: Drug: Mifepristone prior to Mirena |
| Placebo prior to Mirena | Placebo comparator | Pretreatment with placebo prior to Mirena insertion Receives: Drug: Placebo prior to Mirena insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days with bleeding and spotting
To study the effect of pre-treatment with mifepristone on the initial bleeding pattern in women using LNG-IUS (Mirena)
Measured: During the first 3 months of Mirena use
Secondary outcomes (2)
Endometrial changes
To study the effect of mifepristone pre treatment on the endometrium in women before and during treatment with Mirena with special regard to progesteron receptor modulator associated endometrial changes observed following continuos treatment with mifeprsitone (PAEC).
Measured: 3 months post Mirena insertion
Effects on breast tissue
Breast biopsies are obtained at baseline and following 2 months treatment with mifepristone
Measured: Evaluated at end of mifeprsitone treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, MirenaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Gemzell Danielsson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931657
- Sponsor's protocol ID
- W2009M
- Acronym
- MiMi
- Status last verified
- Feb 2016
- First submitted
- 25 Aug 2013
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-treatment With Mifepristone in Patients With Mirena for Optimizing Bleeding Pattern in Pre-menopausal Women
- ClinicalTrials.gov ID
- NCT01931657
- Acronym / sponsor ID
- MiMi / W2009M
- Keywords
- LNG-IUS, Mirena, Contraception, Bleeding, Hormonal effects in the breast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Aug 2013 (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.
Hypothesis: Pretreatment with mifeprsitone prior to Mirena placement will induce amenorrhea and reduce bleeding irrregularities during the initial months of Mirena use.
Detailed description
The levonorgestrel releasing intrauterine system (IUS), Mirena, represents a highly effective contraceptive method that is cost-effective and requires limited patient effort. Furthermore Mirena offers numerous noncontraceptive benefits and addresses different medical needs for women in reproductive and non reproductive age. Side effects such as menstrual abnormalities are important reasons for early discontinuation of a contraceptive method. Irregular bleeding pattern and spotting represents a well known adverse effect during the first months of use with Mirena and corresponds to the most important factor that negatively influences the acceptability of the IUS. Up to today no standard treatment has been suggested to resolve this issue.
By inducing amenorrhea within a short period of treatment with an anti-progesterone, mifepristone, prior to insertion of Mirena, the bleeding irregularities during the first months of use might be reduced and could therefore represent an important strategy for increasing acceptability of this contraceptive system.
The purpose of the present study is to evaluate the bleeding pattern during the first months of use of Mirena in patients treated with mifepristone compared to placebo in women using Mirena for contraception. The study will also address the effect of mifepristone on endometrial morphology and breast tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone prior to Mirena | Experimental | Drug: Mifepristone prior to MirenaPretreatment with mifepristone prior to Mirena insertion |
| Placebo prior to Mirena | Placebo comparator | Drug: Placebo prior to Mirena insertionPretreatment with placebo prior to Mirena insertion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pre-menopausal women, >/= 18 years of age.
- Desire of Mirena for contraception
- Good general health (as judged by; general physical examination
- Willing and able to participate after giving informed consent
Key exclusion criteria (4 listed)
- Any hormonal treatment or IUD use within 2 months prior to study start
- History of malignant disorder of the breast
- Any contraindication to mifepristone
- Pregnancy or breast feeding within 2 months prior to study start
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 |
|---|---|---|
| Mifepristone prior to MirenaAlso: Mifepristone | Drug | Mifepristone prior to Mirena |
| Placebo prior to Mirena insertion | Drug | Placebo prior to Mirena |
Primary outcome
Days with bleeding and spotting
Time frame: During the first 3 months of Mirena use
To study the effect of pre-treatment with mifepristone on the initial bleeding pattern in women using LNG-IUS (Mirena)
2 secondary outcomes
Endometrial changes
Time frame: 3 months post Mirena insertion
Effects on breast tissue
Time frame: Evaluated at end of mifeprsitone treatment
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 25 Feb 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mifepristone prior to Mirena in people with Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, Mirena, run by Karolinska Institutet 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 4 inclusion and 4 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 25 Feb 2016. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Days with bleeding and spotting (time frame: During the first 3 months of Mirena use). 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 25 Feb 2016.