Skip to main content
SpringerLink
Log in

Dihydroxyprogesterone acetophenide 150 mg + estradiol enantate 10 mg as monthly injectable contraceptives

  • Published:
Advances in Contraception

Abstract

A survey among users and health personnel participating in the Salvadorian Social Security Institute (ISSS) Family Planning Program revealed interest in including a monthly preparation for injection as a contraceptive method offered by this Institution. The formulation containing dihydroxyprogesterone acetophenide (DHPA) 150 mg + estradiol enantate (E2EN) 10 mg was chosen for conducting an open and prospective study of efficacy and tolerability. Between January 1992 and March 1994, 7054 women were treated with this product for a total of 60010 months.

A sample composed of 4505 women treated at this Institution confirmed that average users are young, have one or two children, do not show a particular geographical distribution and choose the monthly injection instead of oral contraceptives as the first contraceptive method or for the puerperium.

The study formulation showed a high efficacy (Pearl Index: 0.018) and tolerability (general withdrawal rate throughout the study: 27.09%). The most frequent adverse events included bleeding disorders, headache and mastalgia; their incidence decreased spontaneously from the sixth month (3.9%), reaching 0% after two years. Treatment was discontinued due to adverse events in 3.47% of women. No significant bodyweight or systolic and diastolic blood pressure alterations were observed. Based on these results, the monthly injectable contraceptive was included in the basic product list at ISSS.

Résumé

Une enquête auprès des utilisatrices et du personnel de santé participant au programme de planning familial ISSS a fait ressortir l'intérêt que suscitait l'inclusion d'une préparation administrée par injection une fois par mois en tant que méthode contraceptive offerte par cette institut. Le produit contenant 150 mg d'acétophénide de dihydroxyprogestérone (DHPA)+10 mg d'énanthate d'oestradiol (E2EN) a été choisi pour mener une étude ouverte et prospective en vue de déterminer dans quelle mesure il était efficace et tolérable. Entre janvier 1992 et mars 1994, 7.054 femmes ont été traitées avec ce produit, correspondant à un total de 60.010 mois.

Constituées en groupe échantillon, 4.505 femmes ont fréquenté l'institut, nous permettant de confirmer qu'en moyenne les utilisatrices étaient jeunes, avaient un ou deux enfants, ne correspondaient pas à une distribution géographique particulière et choisissaient l'injection mensuelle comme première méthode contraceptive ou après la période puerpérale, de préférence aux contraceptifs oraux.

Le produit étudié s'est avéré hautement efficace (indice de Pearl 0,018) et tolérable (taux de retrait général pendant la durée de l'étude: 27,09%). Les effets négatifs les plus fréquents comprenaient des troubles de saignements, des céphalées et des mastalgies; ces troubles diminuaient spontanément à partir du sixième mois (3,9%), cessant totalement après deux ans. Le traitement a été abandonné par 3,47% des femmes à cause d'effets négatifs. Aucun changement significatif n'a été observé ni dans le poids corporel, ni dans la pression sanguine systolique et diastolique. Sur la base de ces résultats, le contraceptif mensuel injectable a été inclus dans la liste des produits de base de l'ISSS.

Resumen

Un estudio entre usuarias y personal de atención de la salud del Programa de Planificación Familiar ISSS indicó interés en incluir una preparación mensual inyectable como método anticonceptivo ofrecido por dicha institución. La formulación que contenía 150 mg de acetofenida de dihidroxiprogesterona (DHPA) y 10 mg de enantato de estradiol (E2EN) fue elegida para realizar un estudio prospectivo abierto sobre eficacia y tolerabilidad. Entre enero de 1992 y marzo de 1994, se trató a 7.054 mujeres con este producto durante un total de 60.010 meses.

Una muestra compuesta de 4.505 mujeres atendidas en dicho instituto permitió confirmar que las usuarias medias son jóvenes, tienen uno o más hijos, no señalan ninguna distribución geográfica en particular y eligen la inyección mensual en vez de los anticonceptivos orales como primer método anticonceptivo o para el puerperio.

La formulación estudiada registró una alta tasa de eficacia (Indice de Pearl: 0,018) y tolerabilidad (tasa general de interrupción durante el estudio: 27,09%). Los acontecimientos adversos más frecuentes comprendieron perturbaciones de sangrado, dolor de cabeza y mastalgia; su incidencia disminuyó espontáneamente a partir del sexto mes (3,9%), reduciéndose al 0% al cabo de dos años. El tratamiento fue abandonado debido a acontecimientos adversos por el 3,47% de las mujeres. No se observó ningún cambio significativo del peso corporal o de la tensión arterial sistólica o diastólica. En base a estos resultados, el anticonceptivo inyectable mensual se incluyó en la lista básica de productos del ISSS.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. DiczfalusyE. Fertility regulation-the present and the future. Contraception. 1985;32:1–22.

    PubMed  Google Scholar 

  2. DiczfalusyE. New developments in oral, injectable and implantable contraceptives, vaginal rings and intrauterine devices. A review. Contraception. 1986;33:7–22.

    PubMed  Google Scholar 

  3. HallP. Anticonceptivos inyectables de dosis mensual. Boletin Médico de IPFF. 1987;21:1–2.

    Google Scholar 

  4. LernerLJ, BrennanDM, YiacasE et al. Pregnancy maintenance in ovariectomized rat with 16,17-dihydroxyprogesterone derivatives and other progestogens. Endocrinology. 1962;70:283–7.

    PubMed  Google Scholar 

  5. LernerLJ, DePhillipoM, YiacasE et al. Comparison of the acetophenone derivative of 16,17-dihydroxyprogesterone with other progestational steroids for masculinization of the rat fetus. Endocrinology. 1962;71:448–51.

    PubMed  Google Scholar 

  6. ZarrowMX, YochimJM, McCarthyJL. Experimental endocrinology. London: Academic Press; 1964

    Google Scholar 

  7. TaymorML, PlanckS, YahiaC. Ovulation inhibition with a long-acting parenteral progestogen-estrogen combination. Fertil Steril. 1964;15:653–9.

    PubMed  Google Scholar 

  8. ReifensteinEC, PrattTE, HartzelliKA, ShaferWB. Artificial menstrual cycles induced in ovulating women by monthly injection of progestogen-estrogen. Fertil Steril. 1965;16:652–64.

    PubMed  Google Scholar 

  9. RizkallahTH, TaymorML. Ovulation inhibition with a long-acting injectable. II. The cycling effects of varying progestogen-estrogen combinations. Am J Obstet Gynecol. 1966;94:161–4.

    PubMed  Google Scholar 

  10. VecchioTJ. Long-acting injectable contraceptives. In: Advances in Steroid Biochemistry and Pharmacology. Kalamazzoo, MI: Academic Press; 1976;V5:1–64.

    Google Scholar 

  11. BenagianoG. Long-acting systemic contraceptives. In: DiczfalusyE, ed. Regulation of human fertility. Copenhagen: Scriptor; 1977:323–60.

    Google Scholar 

  12. BenagianoG, PrimieroFM. Long-acting steroid contraceptives. Present status. Drugs. 1983;25:570–609.

    PubMed  Google Scholar 

  13. Sammour MB, Ibrahim WN, Shaker A. A three-year study of liver function during long-acting progestogen-estrogen administration. Contraception. 1973.

  14. Roncales MateoJM, Miñano NavarroA, Gomez CalatayudJM. Experiencia clinica con anticonceptivos hormonales administrados por via inyectable. Toko Ginecologia Practica. 1982;41:63–71.

    Google Scholar 

  15. TylerET, LewinM, ElliotJ et al. Present status of injectable contraceptive results of seven-years study. Fertil Steril. 1970;21:469–81.

    PubMed  Google Scholar 

  16. RustrianAA. Investigación clinica sobre diez años de anticoncepción inyectable mensual. Invest Med Int. 1980;7:27–31.

    PubMed  Google Scholar 

  17. SingerFM, JanuszkaJP, TaftA et al. Radioactive distribution of tritium labeled acetophenone derivative of 16,17-dihydroxyprogesterone (30043). Proc Soc Exp Biol Med. 1965;118:1051–4.

    PubMed  Google Scholar 

  18. GualC, Pérez-PalaciosG, PerezAE et al. Metabolic rate of a long-acting injectable estrogenprogestogen contraceptive. Contraception. 1973;7:271–86.

    Google Scholar 

  19. CastañedaA. Vaginal bleeding patterns in women using the once-a-month injectable contraceptive Perlutal. Adv Contracept. 1995;11:40–1.

    Google Scholar 

  20. SchiavonR, BenavidesS, OropezaG et al. Serum estrogens and ovulation return in chronic users of a once-a-month injectable contraceptive. Contraception. 1988;37:591–8.

    PubMed  Google Scholar 

  21. MoguilevskyJA, WiemeyerJCM, SagastaCL et al. Estrogenic activities of estradiol enantate and ethinylestradiol compared at clinical level. Arzneim Forsch/Drug Res. 1986;36:1671–4.

    Google Scholar 

  22. WiemeyerJCM, GuerreiroRB, FernándezM et al. Experimental findings on the estrogenic activity of estradiol enantate. Arz Forsch/Drug Res. 1986;36:1667–70.

    Google Scholar 

  23. WiemeyerJCM, FernándezM, MoguilevskyJA et al. Pharmacokinetic studies of estradiol enantate in menopausic women. Arz Forsch/Drug Res. 1986;36:1674–7.

    Google Scholar 

  24. WiemeyerJCM, SagastaCL, Roncales MateoJM et al. Multicentred clinical study of the metabolic effect of the monthly injectable contraceptive containing dihydroxyprogesterone acetophenide 150 mg + estradiol enanthate 10 mg. Contraception. 1990;42:13–28.

    PubMed  Google Scholar 

  25. Garza-FloresJ, HallPE. Anticonceptivos inyectables mensuales. In: Pérez-Palacios G, Garza-Flores J, Hall PE. Avances recientes en regulación de la fertilidad: Métodos anticonceptivos de acción prolongada. Piensa, Mexico DF. 1987;Vol I:57–73.

    Google Scholar 

  26. Garza-FloresJ, AlbaVM, CraviotoMC et al. Estrogen-progestogen once-a-month injectable contraceptives and serum prolactin. Contraception. 1989;39:519–29.

    PubMed  Google Scholar 

  27. Melo NR, Oliva-Filho M, Freitas SRMS et al. Evaluation of the hemostasis with the administration of estro-progestative association in a monthly injectable form. XIV World Congress on Fertility and Sterility, Caracas, Venezuela, November 1992 (Abstract).

  28. Melo NR, Latrilha MC, Freitas SR. Levels of lipoprotein (a) [Lp(a)] after two different hormonal contraceptive treatments. XIV World Congress of Fertility and Sterility, Caracas, Venezuela, November 22–27, 1992. Venezuelan Society of Obstetrics and Gynaecology. Abstract book.

  29. ThomasDB, MolinaR, Rodriguez CuevasH et al. Monthly injectable steroid contraceptives and cervical carcinoma. Am J Epidemiol. 1989;130:237–47.

    PubMed  Google Scholar 

  30. JarquínJD et al. Dihydroxyprogesterone acetophenide 150 mg + estradiol enantate 10 mg injectable, contraceptive efficacy and side effects. Adv Contracept. 1995;11:58.

    Google Scholar 

  31. ArcherE. Injectable contraceptives. The role of long-acting progestagens in contraception in developing countries. Save the Children Fund, London, 1985.

    Google Scholar 

  32. WHO Task Force on Long-Acting Systemic Agents for Fertility Regulation. A multicentred Phase III comparative study of two hormonal contraceptive preparations given once-a-month by intramuscular injection. II. The comparison of bleeding patterns. Contraception. 1989;40:531–51.

    Google Scholar 

  33. WHO (OMS). Facts about once-a-month injectable contraceptives: Memorandum from a WHO meeting. Bulletin World Health Organization. 1993;71:677–89.

    Google Scholar 

  34. WallachEE, GarciaCR. Contraception with an intramuscular estrogen-progestogen preparation administered monthly. (Experience with 4512 cycles of use). Contraception. 1970;1:185–207.

    Google Scholar 

  35. Bossemeyer R, Bossemeyer D, Barbosa LCR et al. Estudio multicentrico com a associaçao acetofenido de dihidroxiprogesterona/enantato de estradiol injetável como anticoncepcional em dose única mensal. XII Congresso Brasileiro de Reproduçao Humana, Porto Alegre, Brazil, November 23–27, 1986.

Download references

Author information

Authors and Affiliations

  1. Reproductive Health and Child Care Program, ISSS, San Salvador, El Salvador, Central America

    J. D. Jarquín González

  2. Family Planning Program, ISSS, San Salvador, El Salvador, Central America

    L. Elda de Aguirre

  3. Reproductive Health and Child Care Program, ISSS, San Salvador, El Salvador, Central America

    C. Rodríguez

  4. Reproductive Health Program, Zacamil Health Center, San Salvador, El Salvador, Central America

    M. Abrego de Aguilar

  5. Reproductive Health Program, Atlacatl Health Center, San Salvador, El Salvador, Central America

    F. Carrillo

  6. Reproductive Health Program, Hospital 1° de Mayo, Health Center, San Salvador, El Salvador, Central America

    D. A. León

  7. Reproductive Health Program, Santa Anita Health Center, San Salvador, El Salvador, Central America

    M. Lima

  8. Reproductive Health Program, Ilopango Health Center, San Salvador, El Salvador, Central America

    S. Trigueros

  9. Reproductive Health Center, San Jacinto Health Center, San Salvador, El Salvador, Central America

    R. Acosta

Authors
  1. J. D. Jarquín González
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. L. Elda de Aguirre
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. C. Rodríguez
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. M. Abrego de Aguilar
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. F. Carrillo
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. D. A. León
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. M. Lima
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. S. Trigueros
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. R. Acosta
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Jarquín González, J.D., Elda de Aguirre, L., Rodríguez, C. et al. Dihydroxyprogesterone acetophenide 150 mg + estradiol enantate 10 mg as monthly injectable contraceptives. Adv Contracept 12, 213–225 (1996). https://doi.org/10.1007/BF01849664

Download citation

  • Received:

  • Accepted:

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF01849664

Keywords

Search

Navigation