First year clinical experience with six levonorgestrel rods as subdermal contraception

Area of Science:

• Reproductive Medicine
• Contraception
• Pharmacology

Background:

• Levonorgestrel subdermal implants are effective contraceptives.
• Previous formulations (capsules) had high rates of bleeding disturbances.
• Higher steroid release rates were hypothesized to reduce bleeding.

Purpose of the Study:

• To evaluate the clinical performance of 6 levonorgestrel subdermal rods.
• To compare bleeding patterns and contraceptive outcomes with levonorgestrel capsules.

Main Methods:

• A study involving 50 volunteers using 6 levonorgestrel subdermal rods.
• Comparison with a prior study of 100 volunteers using 6 levonorgestrel capsules.
• Standardized inclusion criteria for both study groups.

Main Results:

• Increased bleeding incidence was halved with rods compared to capsules.
• Amenorrhea incidence doubled, and hypomenorrhea incidence quadrupled with rods.
• No pregnancies occurred in the rod user group.
• Medical discontinuation rates were similar between rods and capsules.

Conclusions:

• Levonorgestrel subdermal rods offer effective contraception with reduced heavy bleeding.
• Altered bleeding patterns (amenorrhea, hypomenorrhea) are more common with rods.
• Rods represent a viable alternative to capsules, with comparable safety profiles.