Journal Article

The Effect of Age, Parity and Body Mass Index on the Efficacy, Safety, Placement and User Satisfaction Associated With Two Low-Dose Levonorgestrel Intrauterine Contraceptive Systems: Subgroup Analyses of Data From a Phase III Trial

Rosen, Kimberly, Apter, Dan, Rybowski, Sarah, Gemzell-Danielsson, Kristina, Nelson, Anita, Hauck, Brian, Schmelter, Thomas

2015

Overview

Two low-dose levonorgestrel intrauterine contraceptive systems (LNG-IUSs; total content 13.5 mg [average approx. 8 μg/24 hours over the first year; LNG-IUS 8] and total content 19.5 mg [average approx. 13 μg/24 hours over the first year; LNG-IUS 13]) have previously been shown to be highly effective (3-year Pearl Indices: 0.33 and 0.31, respectively), safe and well tolerated. The present subgroup analyses evaluated whether or not outcomes were affected by parity, age (18-25 vs 26-35 years), or body mass index (BMI, <30 vs ≥30 kg/m2). Nulliparous and parous women aged 18‒35 years with regular menstrual cycles (21‒35 days) requesting contraception were randomized to 3 years of LNG-IUS 8 or LNG-IUS 13 use. In the LNG-IUS 8 and LNG-IUS 13 groups, 1432 and 1452 women, respectively, had a placement attempted and were included in the full analysis set; 39.2%, 39.2% and 17.1% were 18-25 years old, nulliparous and had a BMI ≥30 kg/m2, respectively. Both systems were similarly effective regardless of age, parity or BMI; the subgroup Pearl Indices had widely overlapping 95% confidence intervals. Placement of LNG-IUS 8 and LNG-IUS 13 was easier (p < 0.0001) and less painful (p < 0.0001) in women who had delivered vaginally than in women who had not. The complete/partial expulsion rate was 2.2-4.2% across all age and parity subgroups and higher in parous than in nulliparous women (p = 0.004). The incidence of pelvic inflammatory disease was 0.1-0.6% across all age and parity subgroups: nulliparous and younger women were not at higher risk than parous and older women, respectively. The ectopic pregnancy rate was 0.3-0.4% across all age and parity subgroups. Across all age and parity subgroups, the 3-year completion rate was 50.9-61.3% for LNG-IUS 8 and 57.9-61.1% for LNG-IUS 13, and was higher (p = 0.0001) among older than younger women in the LNG-IUS 8 group only. LNG-IUS 8 and LNG-IUS 13 were highly effective, safe and well tolerated regardless of age or parity. Clinical trials.gov NCT00528112.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Adolescent / Adult / Age / Age Factors / Analysis / Birth control / Body mass / Body Mass Index / Body size / Clinical trials / Confidence intervals / Consumer Behavior - statistics & numerical data / Contraception / Contraceptive Agents, Female - administration & dosage / Contraceptive Agents, Female - adverse effects / Contraceptive Agents, Female - pharmacology / Contraceptive drug implants / Data processing / Dosage and administration / Dose-Response Relationship, Drug / Ectopic pregnancy / Expulsion / FDA approval / Female / Gynecology / Health care / Humans / Intrauterine devices / Intrauterine Devices, Medicated - adverse effects / Intrauterine Devices, Medicated - statistics & numerical data / IUD / Levonorgestrel / Levonorgestrel - administration & dosage / Levonorgestrel - adverse effects / Levonorgestrel - pharmacology / Liquefied natural gas / Medical research / Menstruation / Obstetrics / Pain / Pain - etiology / Parity / Pelvic inflammatory disease / Pharmaceuticals / Placement / Pregnancy / Pregnancy complications / Product development / Safety / Sexually transmitted diseases / STD / Studies / Subgroups / System effectiveness / Ultrasonic imaging / User satisfaction / Womens health / Young Adult