Essure Clinical Study Designs

Two clinical trials (Phase II and Pivotal, including the extended 5-year follow-up results) demonstrated the efficacy and safety of Essure® permanent birth control. A post-approval study evaluated Essure placement using the current Essure (ESS305) delivery system. The most recent clinical trial (ESSTVU study) evaluated the effectiveness of the Essure procedure when using the TVU/HSG Confirmation Test Algorithm. All clinical trials prior to the ESSTVU study used only the modified HSG as the Essure Confirmation Test. Insert placement was attempted in each fallopian tube. Participants used alternative contraception for 3 months following the procedure.

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Phase II Study with Modified HSG Confirmation Testing
  • The Phase II study was a prospective, multicenter, single-arm, non-randomized international study of women seeking permanent birth control. Study objectives included:
    • Patient tolerance of, and recovery from, the insert placement procedure
    • Safety of the insert placement procedure
    • Patient tolerance of the implanted inserts
    • Long-term safety and stability of implanted inserts
    • Effectiveness of the inserts in preventing pregnancy
  • In this study and the Pivotal study, an Essure Confirmation Test (modified hysterosalpingogram [HSG]) was performed 3 months post-insert placement to evaluate insert location and fallopian tube occlusion. If bilateral location and occlusion were satisfactory, then the patient was instructed to discontinue use of alternative contraception and rely on the Essure inserts for prevention of pregnancy

Population

The Phase II and Pivotal trials combined consisted of 664 participants in whom bilateral insert placement was achieved after one or more attempts (200, Phase II study; 264, Pivotal). Participants were between 21 and 45 years of age and seeking permanent contraception. All participants had at least one live birth, regular menstrual cycles, and were willing to use alternative contraception for the three months following the procedure.

Methods

All study participants were screened for eligibility. Medical history, physical examination and required laboratory tests were performed.

Insert placement was attempted in each fallopian tube. In the Phase II/Pivotal trial, pelvic X-rays were performed within 24 hours of placement to serve as a baseline evaluation of insert location. Participants used alternative contraception for 3 months following the procedure.

A modified HSG was performed 3 months post procedure to evaluate insert location and fallopian tube occlusion. If bilateral placement and occlusion were satisfactory, participants discontinued alternative contraception and relied on the inserts for contraception.

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Pivotal Study with Modified HSG Confirmation Testing
  • The Pivotal study was a prospective, multicenter, single-arm, non-randomized international study of women seeking permanent birth control. The primary end points included:
    • Prevention of pregnancy
    • Safety of insert placement procedure
    • Safety of insert wearing
  • The secondary end points included:
    • Patient satisfaction with insert placement procedure
    • Patient satisfaction with insert wearing
    • Bilateral insert placement rate
    • Profile development for appropriate procedure candidates
  • In this study and the Phase II study, an Essure Confirmation Test (modified hysterosalpingogram [HSG]) was performed 3 months post-insert placement to evaluate insert location and fallopian tube occlusion. If bilateral location and occlusion were satisfactory, then the patient was instructed to discontinue use of alternative contraception and rely on the Essure inserts for prevention of pregnancy

Population

The Phase II and Pivotal trials combined consisted of 664 participants in whom bilateral insert placement was achieved after one or more attempts (200, Phase II study; 264, Pivotal). Participants were between 21 and 45 years of age and seeking permanent contraception. All participants had at least one live birth, regular menstrual cycles, and were willing to use alternative contraception for the three months following the procedure.

Methods

All study participants were screened for eligibility. Medical history, physical examination and required laboratory tests were performed.

Insert placement was attempted in each fallopian tube. In the Phase II/Pivotal trial, pelvic X-rays were performed within 24 hours of placement to serve as a baseline evaluation of insert location. Participants used alternative contraception for 3 months following the procedure.

A modified HSG was performed 3 months post procedure to evaluate insert location and fallopian tube occlusion. If bilateral placement and occlusion were satisfactory, participants discontinued alternative contraception and relied on the inserts for contraception.

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5-Year Extended Follow-up Results of the Pivotal Study
  • The prospective 5-year follow-up study followed the initial cohort of women in the Pivotal clinical trial that led to the approval of Essure® by the US Food and Drug Administration in 2002. This pivotal trial was a multicenter, single-arm, non-randomized international study

Population

The study enrolled previously fertile women 21 to 40 years of age who were seeking permanent contraception, were engaged in a monogamous relationship, and were willing to use a temporary contraceptive method for the first 3 months following Essure insert placement.

Methods

Follow-up via telephone was scheduled for 3, 6, and 18 months post-HSG, soliciting information such as reliance on the Essure inserts, any changes in their partner’s fertility status, and any adverse events or unusual symptoms.

Office visits were scheduled annually at years 1 through 5. Visits at years 1, 2, and 5 included a pelvic exam, pregnancy test, and x-ray verification of Essure insert retention.

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Post-approval Study with Modified HSG Confirmation Testing
  • This study was a prospective, multicenter, single-arm, non-randomized US study intended to document the bilateral placement rate using the current Essure (ESS305) delivery system
  • The primary end point was successful bilateral placement rate at first attempt

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ESSTVU Pivotal Trial with TVU/HSG Confirmation Test Algorithm
  • The ESSTVU Study was a prospective, multi-center, single-arm, non-randomized international study to evaluate the effectiveness of the Essure procedure when the TVU/HSG Confirmation Test Algorithm is used for confirmation testing. The study included the following primary endpoints:
    • Occurrence of confirmed pregnancy at 1 year among subjects relying on Essure inserts for birth control on the basis of the Essure TVU/HSG Confirmation Test Algorithm.
    • Intent-to-treat reliance rate 3 months following Essure TVU/HSG Confirmation Test Algorithm.
  • Population

    The study population of the ESSTVU Study consisted of 597 women in whom insert placement was attempted. Subjects were enrolled at 20 sites (12 in the US and 8 outside of the US). All study participants were between 21 and 44 years of age and were seeking permanent contraception prior to enrollment.

    Methods

    All study participants were screened for eligibility. Medical history, physical examination and required laboratory tests were performed. Insert placement was attempted in each fallopian tube. Participants used alternative contraception for 3 months following the procedure.

    In the ESSTVU study, TVU, modified HSG, or both were utilized in the Essure TVU/HSG Confirmation Test Algorithm in accordance with the current labeling. For TVU confirmation tests done in this study, endovaginal ultrasound probes with center frequencies from 5.8 to 6.5 MHz were utilized.

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