Levonorgestrel called the next great IUD

But when will it reach the United States?

What if you could offer your patients a proven form of birth control that’s not only long-lasting, but is therapeutic for dysfunctional bleeding, as well?

More than 300,000 women worldwide are enjoying the benefits of just such a contraceptive: the levonorgestrel intrauterine device (LNg IUD). Since it was first introduced in 1990, it has been hailed as perhaps the best reversible contraceptive ever devised. It combines the benefits of a progesterone-containing IUD for decreased menstrual flow and less dysmenorrhea with the high effectiveness and long lifespan of a copper-containing IUD. (See enclosed information sheet.)

Sound great? There’s just one catch: It is not available in the United States, and a host of obstacles preclude any forecast of its arrival.

"There are no immediate plans for it entering the United States," confirms Sandra Waldman, spokeswoman for the New York City-based Population Council. The Council, a nonprofit research organization, worked in cooperation with Leiras Oy, a Finnish pharmaceutical company, in developing the device.

Despite that announcement, U.S. family planning clinicians say they would relish adding the LNg IUD to their contraceptive list.

"It definitely would be helpful to my patients," says Susan Roque, MD, a Statesville, NC, private physician. "The efficacy is tremendous when you compare it to any of the other birth control options that are out there."

Low pregnancy rates

The cumulative pregnancy rate at seven years for the LNg IUD is less than 0.5 per 100 women,1 compared to 1.7% for the T380A during a comparable period.2

Many contraceptive methods see a rise in pregnancy rates with younger users, since they are more fertile and sexually active. The LNg IUD maintains the same low pregnancy rate in every age group.3 In a five-year study of 338 LNg IUD users under the age of 25, no pregnancies were recorded.4

Fertility quickly returns once the IUD is removed. Ninety percent of women who used either the LNg or T380A IUD became pregnant within the first year of device removal.5 (For a overview of all IUD pregnancy rates, consult IUDs — An Update, a monograph in the continuing Population Reports series published by the Population Information Program at Johns Hopkins School of Public Health in Baltimore. For ordering information, see the resource box, p. 6.)

The LNg IUD consists of a T-shaped polyethylene frame with a steroid reservoir around its vertical arm. It measures slightly less in length in comparison to the T380A IUD. A membrane coating regulates the daily 20 mcg release of levonorgestrel. Containing 52 mg of the hormone, the LNg IUD has been shown to retain 40% of its steroid load after five years,6 which is the current length of approval for the device in countries where it is available.

Levonorgestrel makes the endometrium insensitive to the estrogen that normally stimulates uterine lining growth. This results in less bleeding during menstruation.7

Studies show that the LNg IUD usually reduces or eliminates monthly blood flow, while the T380A tends to increase blood flow by an additional 20 ml.8 With this feature, the LNg IUD may be used as a therapeutic treatment for both excessive and painful bleeding.9

Levonorgestrel helps to thicken the cervical mucus, which serves to block sperm from reaching the eggs. This thick mucus has been associated with protection against pelvic inflammatory disease (PID), but more research is needed before it can be labeled as effective against PID.10

Spotting may be reported for two to three months as the endometrium adjusts to the LNg’s hormonal effects. Persistent follicles, often associated with other progestin contraceptives such as Norplant and Depo-Provera, also have been noted in some LNg users.11

Good perimenopause contraceptive

For women who are facing menopause and are troubled by heavy bleeding, the LNg IUD is ideal, says Amy E. Pollack, MD, president of Access to Voluntary and Safe Contraception International in New York City. Since it is long-lasting, the LNg IUD can carry a woman through the perimenopause with little chance of pregnancy or removal due to cramping.

"I really think it’s the answer to perimenopausal dysfunctional bleeding," Pollack asserts. "And if you’re in a monogamous relationship and you’re an IUD candidate, why would you use one that doesn’t have a therapeutic effect?"

If the LNg IUD is so terrific, why isn’t it available now to American women?

Economics is a chief deterrent, both in terms of obtaining approval from the Food and Drug Administration (FDA) and the device’s increased cost, says Pollack.

The LNg IUD, because of its hormone reservoir, costs about $250 in U.S. dollars in Europe. In contrast, a copper IUD costs approximately $50 in U.S. dollars when purchased overseas.12

Manufacturers who look at bottom-line figures, then add the costs of moving through the FDA regulatory process, may be dissuaded from attempting U.S. distribution, says Pollack.

Moving past the Dalkon Shield legacy

American women may be ready for the IUD, having turned the corner from the firestorm of lawsuits surrounding the Dalkon Shield. (See Contraceptive Technology Update, May 1995, pp. 57-64, for a comprehensive overview of the IUD scene.)

Educators and policy makers concluded following a February 1996 IUD conference that risks are rare with the two currently available IUDs: the copper-containing ParaGard T380A (Ortho Pharmaceutical Corp., Raritan, NJ) and the progesterone-containing Progestasert (Alza Pharmaceuticals, Palo Alto, CA).13

"The reason it’s not here is not because there isn’t an interest in it, or people don’t think it’s safe or effective," says Pollack of the LNg IUD. "It’s just that we’ve created a really difficult marketplace for IUDs. It’s very hard to turn that around."

References

1. Luukkainen T. IUDs: Future directions and research — Therapeutic use of IUDs. Presented at "IUDs: A State-of-the-Art" conference. Bethesda, MD; February 1996.

2. Rowe PJ. Research on Intrauterine Devices. Annual Technical Report 1991. Geneva, Switzerland: Special Programme of Research, Development, and Research Training in Human Reproduction, World Health Organization; 1992.

3. Luukkainen T, Toivonen J. Levonorgestrel-releasing IUD as a method of contraception with therapeutic properties. Contraception 1995; 52:269-76.

4. Luukkainen T. The levonorgestrel-releasing IUD. Br J Fam Plan 1993; 19(3):221-24.

5. Belhadj H, Sivin I, Diaz S, et al. Recovery of fertility after use of the levonorgestrel 20 mcg/d or Copper T380Ag intrauterine device. Contraception 1986; 34(3):261-267.

6. Keller S. LNg IUD offers less bleeding. Network 1996; 16(2):25.

7. Chi I-c, Farr G. The non-contraceptive effects of the levonorgestrel-releasing intrauterine device. Adv Contracept 1994; 10(4):272.

8. Scholten P, van Eykeren M, Christiaens G, et al. Menstrual blood loss with the levonorgestrel intrauterine device Nova T and Multiload CU 250 intrauterine devices. Thesis. Utrecht: University Hospital; 1989.

9. Andersson JK, Rybo G. Levonorgestrel-releasing intrauterine device in the treatment of menorrhagia. Br J Obstet Gynaecol 1990; 97(8):690-94.

10.Toivonen J, Luukkainen T, Allonen H. Protective effect of intrauterine release of levonorgestrel on pelvic infections: three years’ comparative experience of levonorgestrel and copper-releasing intrauterine devices. Obstet Gynecol 1991; 77(2):261-264.

11. Chi I-c. The TCu-380A (AG), MLCu375, and Nova-T IUDs and the IUD daily releasing 20µg Levonorgestrel: Four pillars of IUD contraception for the 90s and beyond? Contraception 1993; 47(4):340.

12. Keller S. LNg IUD offers less bleeding. Network 1996; 16(2):27.

13. A new push for IUDs. Patient Care 30 May 1996; 11.