• About Us
    • Contact Us
    • Login
    • ObGFirst
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • GrandRounds
  • My Bookshelf
  • COVID-19
About Us Contact Us Login ObGFirst
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • GrandRounds
  • My Bookshelf
  • COVID-19
Grand Rounds

Phase 3 Trial: IUD Efficacy and Safety at 5 Years 

image_pdfFavoriteLoadingFavorite

BACKGROUND AND PURPOSE:

  • Current IUD on the market
    • Total of 52 mg of levonorgestrel | 18.6 micrograms released per day (Liletta)
    • Developed by a non-profit pharmaceutical company to overcome barriers to use of LARC
  • Teal et al. (Obstetrics & Gynecology, 2018) examined the 5-year contraceptive efficacy as part of an ongoing 10-year phase 3 trial

METHODS:

  • 10-year phase 3 contraceptive trial
  • Both nulliparous and parous females
    • 16- 45 years
    • exposed to LNG 52-mg IUD
  • Follow-up visits
    • 4 times in first year
    • After the first year, every 6 months with phone contact between study visits
  • Primary outcome: Pregnancy rate (Pearl Index) through 60 months
  • Additional outcomes
    • Secondary efficacy: Cumulative Pearl Indices over 5
    • Safety evaluation

RESULTS:

  • 1,751 enrollees
    • Successful IUD placement occurred in 1,714 (97.9%) participants
  • 495 participants finished 5 years
  • 176 had entered year 7
    • 9 pregnancies occurred
    • 6 ectopics
  • The Pearl Index was
    • 15 (95% CI 0.02–0.55) at 1 year (per 100 women-years)
    • 20 (95% CI 0.01–1.13) at 5 years (per 100 women-years)
  • The cumulative life-table pregnancy rate was 0.92% (0.46–1.82%) through 5 years
  • Ages 16–35 years: More likely to report
    • New or worsening acne | Dyspareunia | Pelvic pain | Dysmenorrhea
  • Ages 36–45 years: More likely to report
    • New or worsening weight increase
  • Discontinuation for adverse events occurred in 18.8%
    • Expulsion: 3.8% (most common reason)
    • Bleeding symptoms: 2.2%
  • Pelvic infection was diagnosed in 14 (0.8%) participants

CONCLUSION:

  • The IUD 52-mg was effective for all 5 years with a good safety profile

Learn More – Primary Sources:

Five-Year Contraceptive Efficacy and Safety of a Levonorgestrel 52-mg Intrauterine System

 

Now You Can Get Clinical Research Summaries Direct to Your Email/Text

Learn More >>

image_pdfFavoriteLoadingFavorite

< Previous
All Grand Rounds Posts
Next >

Related ObG Topics:

Emergency Contraception: What’s your Best Option?
ACOG & SMFM Guidance on the Use of IUDs and Contraceptive Implants
Emergency Contraception: What, When and How?

Sections

  • Alerts
  • OB
  • GYN
    • GYN
    • Sexual Health
  • 2T US Atlas
  • The Genome
  • Primary Care
  • Your Practice
  • Grand Rounds
  • My Bookshelf
  • COVID-19

Are you an
ObG Insider?

Get specially curated clinical summaries delivered to your inbox every week for free

  • Site Map/
  • © ObG Project/
  • Terms and Conditions/
  • Privacy/
  • Contact Us/
© ObG Project
SSL Certificate


  • Already an ObGFirst Member?
    Welcome back

    Log In

    Want to sign up?
    Get guideline notifications
    CME Included

    Sign Up

Sign In

Lost your password?

Sign Up for ObGFirst and Stay Ahead

  • - Professional guideline notifications
  • - Daily summary of a clinically relevant
    research paper
  • - Includes 1 hour of CME every month

ObGFirst Free Trial

Already a Member of ObGFirst®?

Please log in to ObGFirst to access the 2T US Atlas

Password Trouble?

Not an ObGFirst® Member Yet?

  • - Access 2T US Atlas
  • - Guideline notifications
  • - Daily research paper summaries
  • - And lots more!
ObGFirst Free Trial

Media - Internet

Computer System Requirements

OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Jointly provided by

NOT ENOUGH CME HOURS

It appears you don't have enough CME Hours to take this Post-Test. Feel free to buy additional CME hours or upgrade your current CME subscription plan

Subscribe

JOIN OBGFIRST AND GET CME/CE CREDITS

One of the benefits of an ObGFirst subscription is the ability to earn CME/CE credits from the ObG entries you read. Tap the button to learn more about ObGFirst

Learn More
Leaving ObG Website

You are now leaving the ObG website and on your way to PRIORITY at UCSF, an independent website. Therefore, we are not responsible for the content or availability of this site