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Clinical trial with Nestorone subdermal contraceptive implants
S Díaz1, V Schiappacasse, M Pavez
1Instituto Chileno de Medicina Reproductiva, Santiago, Chile.
Contraception
|January 1, 1995
Summary
A Nestorone subdermal implant provides effective two-year contraception. This study found no pregnancies and well-tolerated implants, with irregular bleeding as the main side effect.
Area of Science:
- Reproductive Medicine
- Endocrinology
- Contraception
Background:
- Subdermal implants offer long-acting reversible contraception.
- Nestorone is a progestin with potential contraceptive applications.
Purpose of the Study:
- To evaluate the clinical performance and in vivo release rate of a Nestorone subdermal implant.
- To compare implants manufactured by two different procedures.
- To assess contraceptive efficacy and safety over a 24-month period.
Main Methods:
- A clinical trial involving 70 healthy women of proven fertility.
- Blood sampling for hormone level analysis (Nestorone, progesterone).
- Monitoring for pregnancy, ovulation, and clinical chemistry parameters.
Main Results:
- No pregnancies occurred in 1570 woman-months of use.
- Nestorone plasma levels declined over 24 months, with effective ovulation suppression.
- Implants were well-tolerated, with irregular bleeding being the most common complaint.
Conclusions:
- A single Nestorone subdermal implant provides efficient contraceptive protection for two years.
- The in vivo release rate was estimated at 45-50 micrograms/day.
- Nestorone implants demonstrated a favorable safety and efficacy profile.