ContraceptionNCT00335257
International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC)
An observational study of Contraception, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
Trial summary
The study compares the short- and long-term risks of a 24-day regimen of a drospirenone-containing oral contraceptive with the risks of established oral contraceptives in a study population that is representative for the actual users of the individual preparations. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- How many people
- 85,109 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2005to Mar 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women using oral contraceptives
Who may be able to join
- First-ever OC users ("starters")
- Women switching OC use without a pill intake break ("switchers")
- Recurrent users with a pill intake break ("recurrent users")
- Women willing to participate in the active surveillance
Who cannot join
- Women who do not agree to participate
- Long-term users
Trial locations and contacts
1 site in 1 country.
About this study
Official title: International Active Surveillance Study of Women Taking Oral Contraceptives (INAS OC)
The study compares the short- and long-term risks of a 24-day regimen of a drospirenone-containing oral contraceptive with the risks of established oral contraceptives in a study population that is representative for the actual users of the individual preparations.
Read the detailed description
Drospirenone is a novel progestogen with antiandrogenic and antimineralocorticoid properties. A large active post-marketing surveillance study has demonstrated that a 21-day regimen of 3mg drospirenone and 30mcg ethinylestradiol can be used safely for oral contraception. This study investigates the risks of short and long-term use of a 24-day regimen of drospirenone/ethinylestradiol in comparison to established OCs in a study population that is representative of the actual users of the individual preparations.
INAS-OC is a prospective, controlled, non-interventional cohort study with two study arms: OCs containing drospirenone and OCs containing any other progestogen. The study was started in the USA in April 2005 and was extended to several European countries in September 2008 based on the launch status of the 24-day regimen. New users of an OC (starters, switchers without a pill intake break and recurrent users with a pill intake break [same or different OC]) are accrued by a network of prescribing physicians. Baseline and follow-up information are collected via a self-administered questionnaire. Data analysis will be based on life-table methods comparing the cohorts. All analyses will make allowance for confounding, using methods that will include multivariate techniques such as Cox regression.
- Conditions
- Contraception
- Keywords
- Drospirenone, Safety, INAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Users of OCs containing DRSP | |
| 2 | Users of OCs containing other progestins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs
Venous thromboembolism (VTE) hazard ratio for oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP.
Measured: Within 60 months
Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs
Arterial thromboembolism (ATE) in women using oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP. Cox regression analysis was not carried out. In accordance to the analysis plan, hazard ratios were only to be calculated if a minimum of 5 confirmed events were available in each of the comparison groups.
Measured: Within 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2006 (estimated)
- Study startAug 2005
- Primary completionJan 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- 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
- 85,109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Epidemiology and Health Research, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
- Investigators
- Juergen C Dinger, MD, PhD, Principal investigator, Center for Epidemiology and Health Research, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335257
- Sponsor's protocol ID
- ZEG 2005-2
- Status last verified
- Aug 2019
- First submitted
- 8 Jun 2006
- Last updated
- 7 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dinger J, Bardenheuer K, Heinemann K. Cardiovascular and general safety of a 24-day regimen of drospirenone-containing combined oral contraceptives: final results from the International Active Surveillance Study of Women Taking Oral Contraceptives. Contraception. 2014 Apr;89(4):253-63. doi: 10.1016/j.contraception.2014.01.023. Epub 2014 Feb 4.
PubMed 24576793Dinger J, Do Minh T, Buttmann N, Bardenheuer K. Effectiveness of oral contraceptive pills in a large U.S. cohort comparing progestogen and regimen. Obstet Gynecol. 2011 Jan;117(1):33-40. doi: 10.1097/AOG.0b013e31820095a2.
PubMed 21213475
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Active Surveillance Study of Women Taking Oral Contraceptives (INAS OC)
- ClinicalTrials.gov ID
- NCT00335257
- Acronym / sponsor ID
- ZEG 2005-2
- Conditions
- Contraception
- Keywords
- Drospirenone, Safety, INAS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85,109 participants (actual)
- Lead sponsor
- Center for Epidemiology and Health Research, GermanyUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Aug 2005
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 9 Jun 2006 (estimated)
- Results
- Posted 18 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study compares the short- and long-term risks of a 24-day regimen of a drospirenone-containing oral contraceptive with the risks of established oral contraceptives in a study population that is representative for the actual users of the individual preparations.
Detailed description
Drospirenone is a novel progestogen with antiandrogenic and antimineralocorticoid properties. A large active post-marketing surveillance study has demonstrated that a 21-day regimen of 3mg drospirenone and 30mcg ethinylestradiol can be used safely for oral contraception. This study investigates the risks of short and long-term use of a 24-day regimen of drospirenone/ethinylestradiol in comparison to established OCs in a study population that is representative of the actual users of the individual preparations.
INAS-OC is a prospective, controlled, non-interventional cohort study with two study arms: OCs containing drospirenone and OCs containing any other progestogen. The study was started in the USA in April 2005 and was extended to several European countries in September 2008 based on the launch status of the 24-day regimen. New users of an OC (starters, switchers without a pill intake break and recurrent users with a pill intake break [same or different OC]) are accrued by a network of prescribing physicians. Baseline and follow-up information are collected via a self-administered questionnaire. Data analysis will be based on life-table methods comparing the cohorts. All analyses will make allowance for confounding, using methods that will include multivariate techniques such as Cox regression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Users of OCs containing DRSP |
| 2 | – | –Users of OCs containing other progestins |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women using oral contraceptives
Key inclusion criteria (4 listed)
- First-ever OC users ("starters")
- Women switching OC use without a pill intake break ("switchers")
- Recurrent users with a pill intake break ("recurrent users")
- Women willing to participate in the active surveillance
Key exclusion criteria (2 listed)
- Women who do not agree to participate
- Long-term users
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs
Time frame: Within 60 months
Venous thromboembolism (VTE) hazard ratio for oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP.
Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs
Time frame: Within 60 months
Arterial thromboembolism (ATE) in women using oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP. Cox regression analysis was not carried out. In accordance to the analysis plan, hazard ratios were only to be calculated if a minimum of 5 confirmed events were available in each of the comparison groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24576793Dinger J, Bardenheuer K, Heinemann K. Cardiovascular and general safety of a 24-day regimen of drospirenone-containing combined oral contraceptives: final results from the International Active Surveillance Study of Women Taking Oral Contraceptives. Contraception. 2014 Apr;89(4):253-63. doi: 10.1016/j.contraception.2014.01.023. Epub 2014 Feb 4.
- Derived from this study: PubMed 21213475Dinger J, Do Minh T, Buttmann N, Bardenheuer K. Effectiveness of oral contraceptive pills in a large U.S. cohort comparing progestogen and regimen. Obstet Gynecol. 2011 Jan;117(1):33-40. doi: 10.1097/AOG.0b013e31820095a2.
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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.
Juergen C Dinger, MD, PhD principal investigator
Center for Epidemiology and Health Research, Berlin, Germany
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 Center for Epidemiology and Health Research, Germany at 1 site in Germany.
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 7 Aug 2019. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 18 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs (time frame: Within 60 months). The study lists 2 primary outcomes in all. 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 NCT00335257, which also lists 2 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 7 Aug 2019.