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 Contraceptio
Phase 3
Completed
- Conditions
- contraceptionwomen ages range 21 to 44 years desiring permanent contraceptionbirth control
- Registration Number
- NL-OMON40387
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
females 21-44 years
seeking permanent contraception
body weight 40-136 kg
sexually active
willing accept risk of pregnancy
medical physical history indicating bilateral viable & patient fallopian tubes
able to comply with 10 year FU visits
Exclusion Criteria
known proximal tubal occlusion
ondergone fallopian tube sterilization
diagnosed endometrial or myometrial pathology
post-menopausal
upper or lower pelvic infection
suspected or confirmed pregnancy
gynecologic malignancy
pregnancy termination less then 6 weeks prior insert p0lacement
known allergy to all contrast media for use in HSG
unicornuate uterus
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Rate of confirmed pregnancies at 1 year among subjects told to rely<br /><br>on ESS505 for contraception.<br /><br>• Reliance rate: number of subjects told to rely on ESS505 after the<br /><br>Essure confirmation test divided by the number of subjects who had insert<br /><br>placement attempted.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Occurrence of confirmed pregnancies at 10 years among subjects told to rely<br /><br>on ESS505 for contraception.<br /><br>• Safety of the ESS505 placement procedure defined as number of subjects who<br /><br>experience an adverse event (AE) assessed as related to the<br /><br>ESS505 placement procedure divided by the number of subjects in who at least 1<br /><br>ESS505 was introduced into the fallopian tube.<br /><br>• Safety of subsequent wearing of the insert defined as number of subjects who<br /><br>experience an AE assessed as related to ESS505 wearing divided by the number of<br /><br>subjects in whom the presence of an AE could be assessed.</p><br>