ContraceptionDIUQoLNCT01731132
DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.
An observational study of Contraception, run by Bayer at 1 site in Spain.
Trial summary
Knowledge about the impact on quality of life of women initiating IUD in the Spanish population at baseline and after 12 months of use. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Levonorgestrel IUD or Copper IUD
- How many people
- 207 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2012to Jul 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 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who starts contraception with an IUD.
Who may be able to join
- 18-49 years old female.
- Women who is visited by a gynecology or primary care physician and starts contraception with an IUD/IUS.
- Women that has not used hormonal contraception in any form in the last 3 months.
- Women who have no problems listening, reading or writing.
- Women who gives their written consent to participate in the study.
Who cannot join
- Women who have contraindications to use IUDs.
- Women with previous experience with IUDs.
- Women who initiates the use of IUDs for other purposes other than contraception.
- Woman who is participating in a clinical trial at the time of initiating the study.
Trial locations and contacts
1 site in 1 country.
About this study
Knowledge about the impact on quality of life of women initiating IUD in the Spanish population at baseline and after 12 months of use.
- Conditions
- Contraception
- Being tested
- Levonorgestrel IUD or Copper IUD
- Keywords
- HRQoL, IUD, Contraception, SEC-QoL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel IUD or Copper IUDDrug
Women who initiate the use of an IUD at the time of the study.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Levonorgestrel IUD or Copper IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire.
Measured: After 12 months
Secondary outcomes (1)
Demographic Data (Age, Place of Birth, Level of Education, Employment status, Personal marital situation, etc.) assessed by questionnaire.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionFeb 2014
- Study completionJul 2014
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 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
- NCT01731132
- Sponsor's protocol ID
- 16341
- Other IDs
- MA1213ES, BAY-DIU-2011-01
- Acronym
- DIUQoL
- Status last verified
- Jul 2015
- First submitted
- 17 Sep 2012
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.
- ClinicalTrials.gov ID
- NCT01731132
- Acronym / sponsor ID
- DIUQoL / 16341
- Conditions
- Contraception
- Keywords
- HRQoL, IUD, Contraception, SEC-QoL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 Nov 2012 (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.
Knowledge about the impact on quality of life of women initiating IUD in the Spanish population at baseline and after 12 months of use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Levonorgestrel IUD or Copper IUD |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who starts contraception with an IUD.
Key inclusion criteria (5 listed)
- 18-49 years old female.
- Women who is visited by a gynecology or primary care physician and starts contraception with an IUD/IUS.
- Women that has not used hormonal contraception in any form in the last 3 months.
- Women who have no problems listening, reading or writing.
- Women who gives their written consent to participate in the study.
Key exclusion criteria (4 listed)
- Women who have contraindications to use IUDs.
- Women with previous experience with IUDs.
- Women who initiates the use of IUDs for other purposes other than contraception.
- Woman who is participating in a clinical trial at the time of initiating the study.
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 IUD or Copper IUDWomen who initiate the use of an IUD at the time of the study. | Drug | Group 1 |
Primary outcome
Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire.
Time frame: After 12 months
1 secondary outcome
Demographic Data (Age, Place of Birth, Level of Education, Employment status, Personal marital situation, etc.) assessed by questionnaire.
Time frame: Baseline
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 Jul 2015.
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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 Spain.
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 5 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 16 Jul 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 Spain. 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?
Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire. (time frame: After 12 months). 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 16 Jul 2015.