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

Stephanie B. Teal, David K. Turok, Beatrice A. Chen, Thomas Kimble, Andrea I. Olariu, Mitchell D Creinin

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

OBJECTIVE: To assess the 5-year contraceptive efficacy and safety of a levonorgestrel (LNG) 52-mg intrauterine system (IUS) from an ongoing 10-year phase 3 contraceptive trial. METHODS: Study investigators enrolled 1,751 nulliparous and parous females aged 16-45 years and desiring contraception to receive a novel LNG 52-mg IUS at 29 centers in the United States, including reproductive health clinics, private offices, and university centers. Participants had scheduled follow-up visits four times during the first year. After year 1, study visits occurred every 6 months, with phone contact at the 3-month point between visits. We assessed the primary outcome of pregnancy rate (Pearl Index) in females aged 16-35 years at enrollment through 60 months. The safety evaluation included all females for their entire duration of participation. RESULTS: The 1,751 enrollees included 1,600 females aged 16-35 years and 151 aged 36-45 years. Successful IUS placement occurred in 1,714 (97.9%) participants. At the time of the data evaluation, 495 participants finished 5 years and 176 had entered the seventh year of IUS use. Nine pregnancies occurred, six of which were ectopic. The Pearl Indices for years 1 and 5 were 0.15 (95% CI 0.02-0.55) and 0.20 (95% CI 0.01-1.13) pregnancies per 100 women-years, respectively. The cumulative life-table pregnancy rate was 0.92% (0.46-1.82%) through 5 years. Participants aged 16-35 years at enrollment were significantly more likely to report new or worsening acne, dyspareunia, pelvic pain, and dysmenorrhea; participants aged 36-45 years at enrollment were more likely to report new or worsening weight increase. Discontinuation for adverse events occurred in 322 (18.8%) participants, most commonly related to expulsion (n=65 [3.8%]). Only 39 (2.2%) IUS users discontinued as a result of bleeding symptoms. Pelvic infection was diagnosed in 14 (0.8%) participants. CONCLUSION: This LNG 52-mg IUS is highly effective and safe over 5 years of use in U.S. females. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT00995150. FUNDING SOURCE: Medicines360.

Original languageEnglish (US)
Pages (from-to)63-70
Number of pages8
JournalObstetrics and Gynecology
Volume133
Issue number1
DOIs
StatePublished - Jan 1 2019

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Levonorgestrel
Contraceptive Agents
Safety
Pregnancy Rate
Pelvic Infection
Dyspareunia
Pregnancy
Dysmenorrhea
Life Tables
Pelvic Pain
Reproductive Health
Acne Vulgaris
Contraception
Research Personnel
Clinical Trials
Hemorrhage
Weights and Measures

ASJC Scopus subject areas

  • Obstetrics and Gynecology

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Five-Year Contraceptive Efficacy and Safety of a Levonorgestrel 52-mg Intrauterine System. / Teal, Stephanie B.; Turok, David K.; Chen, Beatrice A.; Kimble, Thomas; Olariu, Andrea I.; Creinin, Mitchell D.

In: Obstetrics and Gynecology, Vol. 133, No. 1, 01.01.2019, p. 63-70.

Research output: Contribution to journalArticle

Teal, Stephanie B. ; Turok, David K. ; Chen, Beatrice A. ; Kimble, Thomas ; Olariu, Andrea I. ; Creinin, Mitchell D. / Five-Year Contraceptive Efficacy and Safety of a Levonorgestrel 52-mg Intrauterine System. In: Obstetrics and Gynecology. 2019 ; Vol. 133, No. 1. pp. 63-70.
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N2 - OBJECTIVE: To assess the 5-year contraceptive efficacy and safety of a levonorgestrel (LNG) 52-mg intrauterine system (IUS) from an ongoing 10-year phase 3 contraceptive trial. METHODS: Study investigators enrolled 1,751 nulliparous and parous females aged 16-45 years and desiring contraception to receive a novel LNG 52-mg IUS at 29 centers in the United States, including reproductive health clinics, private offices, and university centers. Participants had scheduled follow-up visits four times during the first year. After year 1, study visits occurred every 6 months, with phone contact at the 3-month point between visits. We assessed the primary outcome of pregnancy rate (Pearl Index) in females aged 16-35 years at enrollment through 60 months. The safety evaluation included all females for their entire duration of participation. RESULTS: The 1,751 enrollees included 1,600 females aged 16-35 years and 151 aged 36-45 years. Successful IUS placement occurred in 1,714 (97.9%) participants. At the time of the data evaluation, 495 participants finished 5 years and 176 had entered the seventh year of IUS use. Nine pregnancies occurred, six of which were ectopic. The Pearl Indices for years 1 and 5 were 0.15 (95% CI 0.02-0.55) and 0.20 (95% CI 0.01-1.13) pregnancies per 100 women-years, respectively. The cumulative life-table pregnancy rate was 0.92% (0.46-1.82%) through 5 years. Participants aged 16-35 years at enrollment were significantly more likely to report new or worsening acne, dyspareunia, pelvic pain, and dysmenorrhea; participants aged 36-45 years at enrollment were more likely to report new or worsening weight increase. Discontinuation for adverse events occurred in 322 (18.8%) participants, most commonly related to expulsion (n=65 [3.8%]). Only 39 (2.2%) IUS users discontinued as a result of bleeding symptoms. Pelvic infection was diagnosed in 14 (0.8%) participants. CONCLUSION: This LNG 52-mg IUS is highly effective and safe over 5 years of use in U.S. females. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT00995150. FUNDING SOURCE: Medicines360.

AB - OBJECTIVE: To assess the 5-year contraceptive efficacy and safety of a levonorgestrel (LNG) 52-mg intrauterine system (IUS) from an ongoing 10-year phase 3 contraceptive trial. METHODS: Study investigators enrolled 1,751 nulliparous and parous females aged 16-45 years and desiring contraception to receive a novel LNG 52-mg IUS at 29 centers in the United States, including reproductive health clinics, private offices, and university centers. Participants had scheduled follow-up visits four times during the first year. After year 1, study visits occurred every 6 months, with phone contact at the 3-month point between visits. We assessed the primary outcome of pregnancy rate (Pearl Index) in females aged 16-35 years at enrollment through 60 months. The safety evaluation included all females for their entire duration of participation. RESULTS: The 1,751 enrollees included 1,600 females aged 16-35 years and 151 aged 36-45 years. Successful IUS placement occurred in 1,714 (97.9%) participants. At the time of the data evaluation, 495 participants finished 5 years and 176 had entered the seventh year of IUS use. Nine pregnancies occurred, six of which were ectopic. The Pearl Indices for years 1 and 5 were 0.15 (95% CI 0.02-0.55) and 0.20 (95% CI 0.01-1.13) pregnancies per 100 women-years, respectively. The cumulative life-table pregnancy rate was 0.92% (0.46-1.82%) through 5 years. Participants aged 16-35 years at enrollment were significantly more likely to report new or worsening acne, dyspareunia, pelvic pain, and dysmenorrhea; participants aged 36-45 years at enrollment were more likely to report new or worsening weight increase. Discontinuation for adverse events occurred in 322 (18.8%) participants, most commonly related to expulsion (n=65 [3.8%]). Only 39 (2.2%) IUS users discontinued as a result of bleeding symptoms. Pelvic infection was diagnosed in 14 (0.8%) participants. CONCLUSION: This LNG 52-mg IUS is highly effective and safe over 5 years of use in U.S. females. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT00995150. FUNDING SOURCE: Medicines360.

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