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Clinical trial with subdermal implants containing norgestrienone

S Diaz, M Pavez, E Quinteros

    Contraception
    |October 1, 1978
    PubMed
    Summary
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    Norgestrienone implants provide effective contraception, with a 86.7% continuation rate at 12 months. While generally well-tolerated, irregular bleeding and mild androgenic side effects were noted, warranting annual replacement for optimal contraceptive effect.

    Area of Science:

    • Reproductive Medicine
    • Endocrinology
    • Pharmacology

    Background:

    • Contraceptive implants offer long-acting reversible contraception.
    • Norgestrienone is a progestogen used in hormonal contraceptives.

    Purpose of the Study:

    • To evaluate the contraceptive effectiveness and acceptability of norgestrienone implants.
    • To assess the safety and side effect profile of norgestrienone implants.

    Main Methods:

    • Clinical trial involving 145 women using norgestrienone implants (225 microgram/day).
    • Data collected on pregnancies, continuation rates, bleeding patterns, and side effects.
    • Biochemical and hormonal parameters (blood, urine) monitored.

    Main Results:

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  • Five pregnancies occurred over 2259 woman-months, with a 12-month continuation rate of 86.7%.
  • Increased bleeding days/runs in 12% and amenorrhea in 10% observed; four discontinuations due to bleeding changes.
  • Common side effects included headache and mild androgenicity; lowered cholesterolemia noted in some patients.

    • Conclusions:

    • Norgestrienone implants demonstrate good contraceptive efficacy and acceptability.
    • Annual replacement is recommended for maximal contraceptive effect.
    • Further evaluation of long-term use is warranted due to favorable outcomes.