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Advances in Contraception

, Volume 10, Issue 1, pp 19–26 | Cite as

Safety and efficacy of a combined oral contraceptive: Gestodene 75 μg plus ethinyl estradiol 30 μg in Mexican women

  • J. Garza-Flores
  • V. Valles de Bourges
  • M. Martínez
  • L. Vázquez-Estrada
  • S. Bassol
  • R. Recio
  • G. Pérez-Palacios
Article

Abstract

An open prospective clinical trial designed to evaluate the efficacy and safety of the combined hormonal oral contraceptive (OC) containing 75 μg gestodene plus 30 μg ethinyl estradiol was undertaken in a Mexican population. Sixty-nine healthy women of reproductive age took part in the study for a total of 627 woman-months of observation. The combination of gestodene and ethinyl estradiol proved its effectiveness in preventing pregnancy during the study. Side-effects were minimal and regular endometrial bleeding patterns were observed during one year of continuous use of this OC preparation. The discontinuation rate for medical reasons was 11.6% at one year. Among a sample of 10 women, the gestodene/ethinyl estradiol combination did not induce significant changes in the serum concentration of total cholesterol and LDL cholesterol after 12 months of continuous administration. An increase in serum triglycerides and HDL cholesterol was observed; this effect could be atributed to a lack of androgenic and/or the intrinsic estrogenic behavior of gestodene.

It can be concluded that this preparation is highly effective as a combined oral contraceptive; it is well tolerated and might offer some advantages with respect to other oral contraceptive combinations in its short- and medium-term impact on lipid metabolism.

Keywords

Estradiol Ethinyl Estradiol Combine Oral Contraceptive Mexican Woman Gestodene 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Resumé

Dans une population mexicaine, en étude clinique prospective ouverte a été entreprise dans le but d'évaluer l'efficacité et l'absence de danger que présente le contraceptif hormonal oral contenant 75 μg de gestodène et 30 μg d'éthynil oestradiol. Soixante-neuf femmes en bonne santé et en âge de procréer ont pris part à l'étude, représentant un total de 627 mois-femme d'observation. La combinaison gestodène/éthynil oestradiol a prouvé qu'elle permettait avec efficacité d'empêcher la grossesse au cours de la période d'étude. Les effets secondaires étaient minimes et on a observé des épisodes réguliers de microrragies endométriales au cours d'une année utilisation continue de cette préparation. Les taux d'abandon pour des raisons médicales étaient de 11,6% après une année. La combinaison gestodène/éthynil oestradiol n'a pas occasionné de changements significatifs dans la concentration sérique du cholestérol total et du cholestérol LDL après 12 mois d'administration continue. Bien qu'on ait observé une augmentation des triglycérides sériques et du cholestérol HDL, on a pu attribuer cet effet à un faible pouvoir androgène et/ou à l'action oestrogène intrinsèque du gestodène. On peut conclure que cette préparation est très efficace en tant que contraceptif oral combiné: elle est bien tolérée et pourrait offrir certains avantages si on la compare à d'autres préparations contraceptives et à leurs incidences à court et à moyen terme sur le métabolisme des lipides.

Resumen

En una población mexicana se realizó un estudio clínico prospectivo abierto con el objeto de evaluar la eficacia y seguridad del anticonceptivo hormonal oral con 75 μg de gestodén y 30 μg de etini estradiol. Sesenta y nueve mujeres en buen estado de salud y en edad de procrear participaron en el estudio, durante 627 meses-mujer de observación. La combinación gestodén/etinil estradiol demostró su eficacia en la prevención del embarazo en el curso del estudio. Los efectos secundarios fueron mínimos y se observaron episodios regulares de microrragias del endometrio en el curso de un año de utilización continua de esta formulación. Las tasas de abandono por razones médicas fueron del 11,6% al cabo de un año. La combinación gestodén/etinil estradiol no ocasionó cambios significativos en la concentración sérica del colesterol total y del colesterol LDL al cabo de 12 meses de administración continua. A pesar de observarse un aumento de los triglicéridos séricos y del colesterol HDL, se pudo atribuir este efecto a una falta de poder andrógeno y/o a la acción estrógena intrínseca del gestodén.

Cabe concluir que esta formulación es muy eficaz como anticonceptivo oral combinado: es bien tolerada y podría ofrecer ciertas ventajas con respecto a otras formulaciones anticonceptivas en su impacto de corto a mediano plazo sobre el metabolismo de los lípidos.

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Copyright information

© Kluwer Academic Publishers 1994

Authors and Affiliations

  • J. Garza-Flores
    • 1
  • V. Valles de Bourges
    • 1
  • M. Martínez
    • 1
  • L. Vázquez-Estrada
    • 1
  • S. Bassol
    • 2
  • R. Recio
    • 2
  • G. Pérez-Palacios
    • 1
  1. 1.Departments of Reproductive Biology, and Diabetes and Lipid MetabolismNational Institute of Nutrition S. ZubiránMexico CityMexico
  2. 2.Department of Reproductive Biology, School of MedicineUniversity of CoahuilaTorreónMexico

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