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Clinical trial with 3-keto-desogestrel subdermal implants
S Díaz1, M Pavez, A J Moo-Young
1Consultorio de Planificación Familiar, Instituto Chileno de Medicina Reproductiva, Santiago.
Contraception
|October 1, 1991
Summary
High-dose 3-keto-desogestrel implants effectively prevent pregnancy by inhibiting ovulation. Doses around 40 micrograms per day offer reliable, long-term contraceptive protection with minimal side effects.
Area of Science:
- Reproductive Endocrinology
- Pharmacology
- Contraception
Background:
- Subdermal implants offer a long-acting reversible contraception option.
- 3-keto-desogestrel is a progestin used in hormonal contraceptives.
- Assessing in vivo steroid release and clinical performance is crucial for contraceptive efficacy.
Purpose of the Study:
- To evaluate the clinical performance of 3-keto-desogestrel subdermal implants.
- To determine the in vivo steroid release rates for different implant doses.
- To assess the contraceptive efficacy and safety of these implants.
Main Methods:
- Clinical trial involving healthy women of proven fertility.
- Administration of 3-keto-desogestrel implants with 5 different progestin doses.
- Regular blood sampling to measure 3-keto-desogestrel and progesterone levels.
- Monitoring for pregnancies, ovulation, and adverse clinical events.
Main Results:
- No pregnancies occurred with implants delivering 30-40 µg/day (514 woman-months).
- Higher 3-keto-desogestrel plasma levels (>0.28 nmol/L) correlated with 97% ovulation inhibition.
- Implants delivering ≤20 µg/day resulted in three pregnancies in 109 woman-months.
- Bleeding irregularities were the primary complaint, especially with lower doses.
Conclusions:
- 3-keto-desogestrel implants releasing approximately 40 µg/day provide efficient contraceptive protection.
- Achieving plasma levels around 0.28 nmol/L is associated with effective ovulation inhibition.
- Longer implants (4 cm) showed more consistent drug delivery than shorter ones (4.4 cm).