ContraceptionPOSTNCT01958684
Bleeding Pattern Difference Between Levonorgestrel Intrauterine System (LNG-IUS) and Copper Intrauterine Devices (IUDs) Immediately Inserted After Abortion
An observational study of Contraception, run by Bayer at 1 site in China.
Trial summary
To observe the bleeding patterns of post-abortion immediate insertion of IUS compared to Cu-IUD over the first 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Levonorgestrel IUS (Mirena, BAY86-5028) and Copper-IUD
- Type of treatment
- Medical device
- How many people
- 512 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Oct 2014
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All subjects should go through the surgical abortion should meet both inclusion and exclusion criteria. And they are willing to sign an informed consent. And all recruitment should be conducted after the decision of treatment.
Who may be able to join
- Reproductive women in good general health and requesting long-term contraception
- Applied the Cu-IUD or LNG-IUS immediately after first trimester surgical abortion
- History of regular cyclic menstrual periods
- Written ICF was obtained
Who cannot join
- Suspected septic abortion and incomplete abortion, as well as missed abortion
- The contraindications and warnings of the respective Summary of Product Characteristics of Mirena or prescribing information of Cu-IUDs must be followed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-interventional Study to Observe the Bleeding Pattern of LNG-IUS Inserted Immediately After Surgical Abortion Compared With Copper IUD
To observe the bleeding patterns of post-abortion immediate insertion of IUS compared to Cu-IUD over the first 6 months.
- Conditions
- Contraception
- Being tested
- Levonorgestrel IUS (Mirena, BAY86-5028), Copper-IUD
- Keywords
- Bleeding pattern, LNG-IUS, Cu-IUD, postabortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel IUS (Mirena, BAY86-5028)Drug
Also called Mirena Group
LNG-IUS once inserted will be effective for 5 years.
Copper-IUDDevice
Also called Cu-IUD Group
Copper-IUD once inserted will be effective for more than 10 years.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | The MIRENA intrauterine delivery system (initial release rate: 20 μg LNG /24 h) Receives: Drug: Levonorgestrel IUS (Mirena, BAY86-5028) | |
| Group 2 | Copper IUDs with different shape and with or without drugs Receives: Device: Copper-IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of bleeding/spotting days assessed over the second 90-day reference period after induced abortion
The 90-day reference period is recommended by the WHO. Day 1 is defined as the insertion day.
Measured: Months 4 to 6
Secondary outcomes (7)
Menstrual bleeding intensity
It will be captured by patient dairy and measured by subjective scale as below.
- No bleeding
- Light bleeding
- Normal bleeding
- Heavy bleeding
- Very heavy bleeding
Measured: up to 6 months
Abortion related bleeding days
Measured: up to 1 month
Time to the first menstrual bleeding following abortion
This data will be calculated by days
Measured: up to 2 months
Participants continuation rates of Mirena and Cu-IUD
Measured: up to 6 months
Reasons for discontinuation of Mirena and Cu-IUD
It will be calculated by percentage
Measured: Up to 6 months
Participants satisfaction rates of Mirena and Cu-IUD
It will be captured by satisfaction scale as below.
- Very satisfied
- Rather satisfied
- neither satisfied nor dissatisfied
- Rather unsatisfied
- Very unsatisfied
Measured: Up to 6 months
Percentage of participants with adverse events
Adverse events included: Pelvic inflammatory disease, Expulsion and Others.)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionOct 2014
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 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
- 512 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
- NCT01958684
- Sponsor's protocol ID
- 16954
- Other IDs
- MA1310CN
- Acronym
- POST
- Status last verified
- Oct 2015
- First submitted
- 7 Oct 2013
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chen X, Li Q, Wang X, Chen J, Lv W, Shi B, Wang H, Luo J, Li J. Bleeding pattern difference between levonorgestrel intrauterine system and copper intrauterine devices inserted immediately post-abortion: a multicenter, prospective, observational cohort study in Chinese women. Curr Med Res Opin. 2018 May;34(5):873-880. doi: 10.1080/03007995.2017.1421919. Epub 2018 Feb 7.
PubMed 29298525
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study to Observe the Bleeding Pattern of LNG-IUS Inserted Immediately After Surgical Abortion Compared With Copper IUD
- ClinicalTrials.gov ID
- NCT01958684
- Acronym / sponsor ID
- POST / 16954
- Conditions
- Contraception
- Keywords
- Bleeding pattern, LNG-IUS, Cu-IUD, postabortion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 9 Oct 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.
To observe the bleeding patterns of post-abortion immediate insertion of IUS compared to Cu-IUD over the first 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Levonorgestrel IUS (Mirena, BAY86-5028)The MIRENA intrauterine delivery system (initial release rate: 20 μg LNG /24 h) |
| Group 2 | – | Device: Copper-IUDCopper IUDs with different shape and with or without drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects should go through the surgical abortion should meet both inclusion and exclusion criteria. And they are willing to sign an informed consent. And all recruitment should be conducted after the decision of treatment.
Key inclusion criteria (4 listed)
- Reproductive women in good general health and requesting long-term contraception
- Applied the Cu-IUD or LNG-IUS immediately after first trimester surgical abortion
- History of regular cyclic menstrual periods
- Written ICF was obtained
Key exclusion criteria (2 listed)
- Suspected septic abortion and incomplete abortion, as well as missed abortion
- The contraindications and warnings of the respective Summary of Product Characteristics of Mirena or prescribing information of Cu-IUDs must be followed
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 IUS (Mirena, BAY86-5028)Also: Mirena GroupLNG-IUS once inserted will be effective for 5 years. | Drug | Group 1 |
| Copper-IUDAlso: Cu-IUD GroupCopper-IUD once inserted will be effective for more than 10 years. | Device | Group 2 |
Primary outcome
The number of bleeding/spotting days assessed over the second 90-day reference period after induced abortion
Time frame: Months 4 to 6
The 90-day reference period is recommended by the WHO. Day 1 is defined as the insertion day.
7 secondary outcomes
Menstrual bleeding intensity
Time frame: up to 6 months
Abortion related bleeding days
Time frame: up to 1 month
Time to the first menstrual bleeding following abortion
Time frame: up to 2 months
Participants continuation rates of Mirena and Cu-IUD
Time frame: up to 6 months
Reasons for discontinuation of Mirena and Cu-IUD
Time frame: Up to 6 months
Participants satisfaction rates of Mirena and Cu-IUD
Time frame: Up to 6 months
Percentage of participants with adverse events
Time frame: Up to 6 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 16 Oct 2015.
- Derived from this study: PubMed 29298525Chen X, Li Q, Wang X, Chen J, Lv W, Shi B, Wang H, Luo J, Li J. Bleeding pattern difference between levonorgestrel intrauterine system and copper intrauterine devices inserted immediately post-abortion: a multicenter, prospective, observational cohort study in Chinese women. Curr Med Res Opin. 2018 May;34(5):873-880. doi: 10.1080/03007995.2017.1421919. Epub 2018 Feb 7.
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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 China.
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 2 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 16 Oct 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 China. 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?
The number of bleeding/spotting days assessed over the second 90-day reference period after induced abortion (time frame: Months 4 to 6). 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 NCT01958684, 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 16 Oct 2015.