A Phase 3, Randomized, Multi-Center, open-Label Study of a Levonorgestrel-Releasing Intrauterine System (20 mcg/day) (LNG20) and Mirena for Long-Term, Reversible contraception up to Five Years
This is a Phase 3, randomized, open-label, multicenter evaluation of the efficacy of a levonorgestrel-releasing intrauterine system (LnG20). a marketed levonorgestrel-releasing intrauterine system (Mirena) will be included to act as an infomartive comparator.
eligible subjects 16-35 years of age will be randomized to one of two iuS arms to include approximately 1900 subjects using LnG20 and 400 subjects using Mirena. The randomization will be performed in an approximate 4:1 ratio. an additional 150 eligible females 36-45 years of age will receive LnG20 as part of a non-randomized cohort. We plan to consent 75 women age 18-45 years at uT Southwestern in order to have 60 subjects who will participate in the protocol.
Th non-randomized cohort for LnG20 for ages 36-45 and the Mirena cohort aare now completed and close to enrollment.
Subjects must fulfill all of the following criteria to be eligible for study entry:
1) Signed informed consent
2) Healthy females 18-45 years of age, inclusive, at the time of enrollment
3) Regularly sexually active and in a mutually monogamous relationship for
at least 6 months at study entry
4) Willing to rely on the study IUS as the primary method of contraception
during study participation
5) History of regular menstrual cycles defined as occurring every 21-35
days when not using hormones and with a variation of typical cycle
length of no more than 5 days
6) Willing to comply with study visit schedule and assessments, including
diary completion requirements
7) Planning to reside within a reasonable driving distance of a study
research site (approximately 150 miles) for at least 2 years