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Gestoden, an innovative progestogen.

G Hoppe1

  • 1Far East Scientific Office-Clinical Research Centre Schering AG, Manila, Philippines.

Contraception
|May 1, 1988
PubMed
Summary
This summary is machine-generated.

New oral contraceptives with gestoden and ethinylestradiol (EE) offer reliable contraception and improved cycle control. Gestoden

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Area of Science:

  • Endocrinology
  • Pharmacology
  • Cardiovascular Medicine

Background:

  • Ethinylestradiol (EE) is a widely used estrogen in oral contraceptives (OCs), known for potent liver metabolism effects.
  • EE may induce metabolic and hemostatic changes, with some studies linking OCs to rare cardiovascular events (thromboembolic, hypertensive).
  • Potential EE-induced adverse effects on coagulation, fibrinolysis, and the renin-angiotensin-aldosterone system are significant.

Purpose of the Study:

  • To evaluate a new synthetic progestogen, gestoden, for its anti-estrogenic and aldosterone-antagonistic properties.
  • To assess the contraceptive efficacy, cycle control, and tolerance of a low-dose OC formulation containing gestoden and EE.
  • To investigate the impact of the gestoden-EE combination on blood pressure in women with pre-existing hypertension.

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Main Methods:

  • Multicentric clinical trials involving 1,095 women over 14,281 treatment cycles.
  • Administration of an oral contraceptive containing 75 mcg gestoden and 30 mcg ethinylestradiol (EE).
  • Monitoring of contraceptive efficacy, cycle control, tolerance, and blood pressure changes.

Main Results:

  • The gestoden-EE combination demonstrated reliable contraceptive efficacy and excellent cycle control.
  • The formulation was well-tolerated by the study participants.
  • Blood pressure normalized in approximately 60% of women with elevated blood pressure prior to treatment.

Conclusions:

  • Gestoden possesses significant anti-estrogenic and unique aldosterone-antagonistic effects, counteracting potential EE-induced adverse changes.
  • Low-dose oral contraceptives containing gestoden and EE provide effective contraception with favorable cycle control and blood pressure management.
  • Gestoden represents a valuable progestogen for OC formulations, offering enhanced safety and efficacy profiles.