#Grand Rounds

Phase 3 Trial: IUD Efficacy and Safety at 5 Years

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

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

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

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