New intrauterine device now is in research
An experimental levonorgestrel 20 mcg intrauterine device (LNG20 IUD) is under development by Medicines360, a San Francisco-based nonprofit pharmaceutical company. The company recently entered into a partnership with Actavis (formerly Watson Pharmaceuticals), a Parsippany, NJ-based pharmaceutical company, with an eye to allow Medicines360 to make the IUD available at a low price to U.S. public sector clinics. Should the device be approved by the Food and Drug Administration, the IUD could be launched in the United States as early as 2014.
The Phase 3 clinical trial of the Medicines360 IUD began in 2009. Its enrollment is complete; however the study is ongoing and is projected to conclude in 2018, says Victoria Hale, PhD, founder and president of Medicines 360. A total of 27 sites are participating in the study, which is designed as a randomized, multi-center, open-label study comparing the Medicines360 20 mcg levonorgestrel-releasing intrauterine system and the currently available Mirena IUD (Bayer HealthCare Pharmaceuticals, Wayne, NJ) for long-term, reversible contraception up to five years.
As part of its agreement with Medicines360, Actavis has licensed the U.S. commercial rights for the LNG20 IUD, while Medicines360 retains rights to market the product in the U.S. public sector, including family planning clinics that provide services to low-income women.
Take a closer look
Originally developed by Uteron Pharma Operations of Liege, Belgium, the LNG20 IUD consists of a T-shaped polyethylene frame with a steroid reservoir around its vertical stem. Its steroid reservoir is covered with a polydimethylsiloxane membrane that controls the release rate of levonorgestrel from the reservoir, and a polypropylene monofilament blue thread is attached to the end of its vertical stem. The device’s reservoir contains 52 mg levonorgestrel, which provides a daily release rate of 20 mcg.
European researchers compared the safety and efficacy of the LNG20 and the Mirena IUDs in a 12-month study for treatment of menorrhagia. A total of 280 women with menorrhagia were recruited at 15 European sites to conduct the study. Women with a mean blood loss per cycle of at least 80 ml over three baseline cycles were randomized in a one-to-one ratio to LNG20 or Mirena. Patients were seen at weeks one, two, four, 13, 24, 38, and 52.
Mean change in blood loss for each individual from baseline was 150 ±85 ml for LNG20 users (n=108) and 152±105 ml for Mirena users (n=100), for a ratio of 0.99. Continuation rates were 88.7% (125/141) for LNG20 and 87.1% (121/139) for Mirena (p=.7). Expulsion rates were 4.3% (6/141) and 3.6% (5/139), respectively (p=.8). One pregnancy, after device expulsion, occurred in the LNG20 group, and no pregnancies occurred in the Mirena group. The incidence of adverse events was similar between groups. Only one reported serious adverse event (bilateral ovarian cysts), reported in a LNG20 subject, was considered possibly related to device use. The two devices have similar safety and efficacy profiles when used for treatment of menorrhagia, researchers conclude.1
In a planned substudy of the menorrhagia trial, the LNG20 and Mirena produced equivalent plasma levonorgestrel levels in women with menorrhagia over the first six months of use.2 A study that compared the in vitro release rates of LNG20 and the Mirena also was performed. Scientists looked at the release rate performance of seven LNG20 and seven Mirena devices, each with a reservoir length of 20 mm surrounded by a release rate controlling membrane, in an in vitro diffusion test in sink conditions for approximately three years. The in vitro release rates were found to be similar over three years, data indicates.3
Meeting a need
Intrauterine devices in general have been shown to be a very effective contraceptive, but they have been too expensive for most women, says Hale. Medicines360’s motivation is to provide access to effective birth control options regardless of a person’s income, Hale said in a press statement announcing the corporate partnership.
"Actavis shares our vision of a world in which a woman’s access to birth control is not compromised by lack of education, product availability or price," Hale stated. "Having control over if and when she becomes pregnant empowers a woman to make choices that positively impact her life and the lives of others."
By leveraging Actavis’ expertise in development, distribution, and manufacturing, Medicines360 is better prepared to address a primary unmet healthcare need for many American women, Hale noted.
If more women could switch to long-acting reversible contraceptives (LARCs), such as intrauterine contraception, impact could be made on unintended pregnancy, according to a recently published study. It evaluated the total costs of unintended pregnancy in the United States from a third-party healthcare payer perspective. If 10% of U.S. women ages 20-29 switched from oral contraception to LARCs, total costs would be reduced by $288 million per year, the study found.4
- Gordenne V, Wijzen F, Foidart J-M, et al. Comparison of LNG20, a new levonorgestrel intrauterine system, and Mirena for treatment for menorrhagia. Contraception 2010; 82:213.
- Gordenne V, Wijzen F, Foidart J-M, et al. Comparison of LNG20, a new levonorgestrel intrauterine system, and Mirena for treatment for menorrhagia. Contraception 2010; 82:193.
- Wijzen F. Levonorgestrel release rates with LNG20, a new levonorgestrel intrauterine system, and Mirena. Contraception 2010; 82:193.
- Trussell J, Henry N, Hassan F, et al. Burden of unintended pregnancy in the United States: potential savings with increased use of long-acting reversible contraception. Contraception 2013; 87:154-161.