ContraceptionNCT01948882
Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women
A study testing ESS505 (BAY1454033) in people with Contraception, run by Bayer at 22 sites in 4 countries.
Trial summary
The Essure System is indicated for women who desire non-incisional permanent birth control (female sterilization) by occlusion of the fallopian tubes. The objective of the study is to evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent birth control in preventing pregnancy. Read more about this study
- Who is it for?
- Ages 21 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- ESS505 (BAY1454033)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 30 Sep 2013to 12 Sep 2024
- Phase
- Interventional
- 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 21 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, 21 to 44 years of age, inclusive
- Body weight within range of 90-300 lbs (40 - 136 kg)
- Sexually active (minimum of 4 coital acts per cycle)
- Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
- Medical history indicates bilateral viable and patent fallopian tubes
- Agrees to fulfill local requirements for counseling and consent to contraception and sterilization, including any required waiting periods
Who cannot join
- Post-menopausal woman
- Suspected or confirmed pregnancy
- Post-partum or pregnancy termination ≤6 weeks of scheduled insert placement
- Past fallopian tube sterilization procedure and/or total or partial salpingectomies
- Diagnosis of any of the following: tubal, endometrial, or myometrial pathology (which may prevent fallopian tube ostia access), proximal tubal occlusion in either fallopian tube, unicornuate uterus, active or recent upper or lower pelvic infection, gynecologic malignancy
- Currently taking corticosteroids
Show all 9Show fewer
- Known allergy to all contrast media available for use in hysterosalpingogram
- Scheduled to undergo concomitant intrauterine procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure)
- Any general health condition or systemic disease that may represent, in the opinion of the physician, a potential increased risk associated with device use or pregnancy
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
United States17 sites
Study site
Asheville, North Carolina, 28801
Study site
Aurora, Colorado, 80045
Study site
Cincinnati, Ohio, 45242
Study site
Columbia, Ohio, 60004
Study site
Dallas, Texas, 75208
Study site
Denver, Colorado, 80231
Study site
Fort Wayne, Indiana, 46825
Study site
Houston, Texas, 77074
Study site
Irving, Texas, 75062
Study site
New York, New York, 10032
Study site
Newburgh, Indiana, 47630
Study site
Norfolk, Virginia, 23507
Study site
Rochester, Minnesota, 55905
Study site
Saginaw, Michigan, 48604
Study site
Spokane, Washington, 99204
Study site
The Bronx, New York, 10467
Study site
Wellington, Florida, 33414
Canada2 sites
Study site
Hamilton, Ontario, L8L 2X2
Study site
Regina, Saskatchewan, S4S 6X3
Spain2 sites
Study site
Córdoba, 14004
Study site
L'Hospitalet de Llobregat, Barcelona, 08906
About this study
Official title: A Multi-Center, Multi-National Clinical Study to Evaluate the Safety and Effectiveness of the Essure® (Model ESS505) Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception
The Essure System is indicated for women who desire non-incisional permanent birth control (female sterilization) by occlusion of the fallopian tubes. The objective of the study is to evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent birth control in preventing pregnancy. The Essure ESS505 System includes a design modification that will be studied to determine if it provides immediate birth control, thereby removing the three months waiting period required for the commercially available Essure System Model 305 to be effective.
- Conditions
- Contraception
- Being tested
- ESS505 (BAY1454033)
- Keywords
- Birth control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESS505 (BAY1454033)Device
| Study group | Role | What they receive |
|---|---|---|
| ESS505 | Experimental | All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure. Receives: Device: ESS505 (BAY1454033) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of confirmed pregnancies at 1 year among subjects told to rely on ESS505 for contraception
Evaluated after 6000 women-months of reliance have been accumulated
Measured: 1 year
Reliance rate, defined as number of subjects told to rely on ESS505 after the Essure confirmation test divided by the number of subjects who had insert placement attempted
Evaluated after 3000 women-months of reliance have been accumulated (expected at the same time most subjects with implants have completed their 3 month follow-up visit)
Measured: 3 months
Secondary outcomes (3)
Number of confirmed pregnancies at 10 years among subjects told to rely on ESS505 for contraception
Measured: 10 years
Safety of the ESS505 placement procedure defined as number of subjects who experience an AE assessed as related to the ESS505 placement procedure divided by the number of subjects in who at least one ESS505 was introduced into the fallopian tube
Measured: On day of placement procedure
Safety of subsequent wearing of the insert defined as number of subjects who experience an AE assessed as related to wearing of ESS505 divided by the number of subjects in whom the presence of an AE could be assessed
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study start30 Sep 2013
- Primary completion16 Sep 2015
- Study completion12 Sep 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 660 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
- NCT01948882
- Sponsor's protocol ID
- 16973
- Status last verified
- Oct 2024
- First submitted
- 19 Sep 2013
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Multi-National Clinical Study to Evaluate the Safety and Effectiveness of the Essure® (Model ESS505) Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception
- ClinicalTrials.gov ID
- NCT01948882
- Acronym / sponsor ID
- 16973
- Conditions
- Contraception
- Keywords
- Birth control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2013 (actual)
- Primary completion
- 16 Sep 2015 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 24 Sep 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.
The Essure System is indicated for women who desire non-incisional permanent birth control (female sterilization) by occlusion of the fallopian tubes. The objective of the study is to evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent birth control in preventing pregnancy. The Essure ESS505 System includes a design modification that will be studied to determine if it provides immediate birth control, thereby removing the three months waiting period required for the commercially available Essure System Model 305 to be effective.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESS505 | Experimental | Device: ESS505 (BAY1454033)All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure. |
Who may qualify
- Ages
- 21 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female, 21 to 44 years of age, inclusive
- Body weight within range of 90-300 lbs (40 - 136 kg)
- Sexually active (minimum of 4 coital acts per cycle)
- Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
- Medical history indicates bilateral viable and patent fallopian tubes
Key exclusion criteria (9 listed)
- Post-menopausal woman
- Suspected or confirmed pregnancy
- Post-partum or pregnancy termination ≤6 weeks of scheduled insert placement
- Past fallopian tube sterilization procedure and/or total or partial salpingectomies
- Diagnosis of any of the following: tubal, endometrial, or myometrial pathology (which may prevent fallopian tube ostia access), proximal tubal occlusion in either fallopian tube, unicornuate uterus, active or recent upper or lower pelvic infection, gynecologic malignancy
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 |
|---|---|---|
| ESS505 (BAY1454033) | Device | ESS505 |
Primary outcome
Number of confirmed pregnancies at 1 year among subjects told to rely on ESS505 for contraception
Time frame: 1 year
Evaluated after 6000 women-months of reliance have been accumulated
Reliance rate, defined as number of subjects told to rely on ESS505 after the Essure confirmation test divided by the number of subjects who had insert placement attempted
Time frame: 3 months
Evaluated after 3000 women-months of reliance have been accumulated (expected at the same time most subjects with implants have completed their 3 month follow-up visit)
3 secondary outcomes
Number of confirmed pregnancies at 10 years among subjects told to rely on ESS505 for contraception
Time frame: 10 years
Safety of the ESS505 placement procedure defined as number of subjects who experience an AE assessed as related to the ESS505 placement procedure divided by the number of subjects in who at least one ESS505 was introduced into the fallopian tube
Time frame: On day of placement procedure
Safety of subsequent wearing of the insert defined as number of subjects who experience an AE assessed as related to wearing of ESS505 divided by the number of subjects in whom the presence of an AE could be assessed
Time frame: Up to 10 years
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 17 Oct 2024.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESS505 (BAY1454033) in people with Contraception, run by Bayer at 22 sites in 4 countries.
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 6 inclusion and 9 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 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada, Spain, Netherlands. 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?
Number of confirmed pregnancies at 1 year among subjects told to rely on ESS505 for contraception (time frame: 1 year). 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?
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 17 Oct 2024.