Get ObGFirst Guideline Alerts Direct to Your Phone | Learn More Here » X

#Grand Rounds

Phase 3 Trial: IUD Efficacy and Safety at 5 Years 

FavoriteLoading

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 >>

FavoriteLoading

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?

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