Abstract
This Memorandum reviews the results of research undertaken in animals and human subjects on once-a-month injectable contraceptives containing a progestogen and an estrogen, in particular the products Cyclofem and Mesigyna. Results from clinical trials, including effectiveness and side-effects, are evaluated and issues arising from health service research are discussed. The Memorandum concludes with a statement regarding the use of Cyclofem and Mesigyna as options for potential contraceptive users.
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- Aedo A. R., Landgren B. M., Johannisson E., Diczfalusy E. Pharmacokinetic and pharmacodynamic investigations with monthly injectable contraceptive preparations. Contraception. 1985 May;31(5):453–469. doi: 10.1016/0010-7824(85)90081-2. [DOI] [PubMed] [Google Scholar]
- Belsey E. M., Farley T. M. The analysis of menstrual bleeding patterns: a review. Contraception. 1988 Aug;38(2):129–156. doi: 10.1016/0010-7824(88)90035-2. [DOI] [PubMed] [Google Scholar]
- Benagiano G., Primiero F. M. Long acting contraceptives. Present status. Drugs. 1983 Jun;25(6):570–609. doi: 10.2165/00003495-198325060-00003. [DOI] [PubMed] [Google Scholar]
- Coutinho E. M., Carlos de Souza J. Conception control by monthly injections of medroxyprogesterone suspension and long-acting oestrogen. J Reprod Fertil. 1968 Mar;15(2):209–214. doi: 10.1530/jrf.0.0150209. [DOI] [PubMed] [Google Scholar]
- Fotherby K., Benagiano G., Toppozada H. K., Abdel-Rahman A., Navaroli F., Arce B., Ramos-Cordero R., Gual C., Landgren B. M., Johannisson E. A preliminary pharmacological trial of the monthly injectable contraceptive cycloprovera. Contraception. 1982 Mar;25(3):261–272. doi: 10.1016/0010-7824(82)90049-x. [DOI] [PubMed] [Google Scholar]
- Garza-Flores J., Alba V. M., Cravioto M. C., Hernandez L., Perez-Palacios G., Alvarado G., Rivera R., Recio R., Bassol S. Estrogen-progestogen once-a-month injectable contraceptives and serum prolactin. Contraception. 1989 May;39(5):519–529. doi: 10.1016/0010-7824(89)90107-8. [DOI] [PubMed] [Google Scholar]
- Garza-Flores J., Fatinikun T., Hernandez L., Ramos I., Cardenas M., Menjivar M. A pilot study on the assessment of a progesterone/estradiol sustained release as once-a-month-injectable contraceptive. Contraception. 1991 Jul;44(1):45–59. doi: 10.1016/0010-7824(91)90105-o. [DOI] [PubMed] [Google Scholar]
- Haiba N. A., el-Habashy M. A., Said S. A., Darwish E. A., Abdel-Sayed W. S., Nayel S. E. Clinical evaluation of two monthly injectable contraceptives and their effects on some metabolic parameters. Contraception. 1989 Jun;39(6):619–632. doi: 10.1016/0010-7824(89)90037-1. [DOI] [PubMed] [Google Scholar]
- Herzog G. M., Soule S. D. Control of fertility by monthly injection of estrogen-progestogen. Obstet Gynecol. 1968 Jul;32(1):111–115. [PubMed] [Google Scholar]
- Jordan A. FDA requirements for nonclinical testing of contraceptive steroids. Contraception. 1992 Dec;46(6):499–509. doi: 10.1016/0010-7824(92)90114-9. [DOI] [PubMed] [Google Scholar]
- Keifer W. S., Lee A. F., Scott J. C. A clinical evaluation of a monthly injection for conception control. Am J Obstet Gynecol. 1970 Jun 1;107(3):400–410. doi: 10.1016/0002-9378(70)90566-1. [DOI] [PubMed] [Google Scholar]
- Koetsawang S., Nukulkarn P., Fotherby K., Shrimanker K., Mangalam M., Towobola K. Transfer of contraceptive steroids in milk of women using long-acting gestagens. Contraception. 1982 Apr;25(4):321–331. doi: 10.1016/0010-7824(82)90090-7. [DOI] [PubMed] [Google Scholar]
- Koetsawang S., Srisupandit S., Kiriwat O., Koetsawang A. The monthly injectable contraceptive: a two-year clinical trial. Int J Gynaecol Obstet. 1978;16(1):61–64. doi: 10.1002/j.1879-3479.1978.tb00396.x. [DOI] [PubMed] [Google Scholar]
- Koetsawang S. The effects of contraceptive methods on the quality and quantity of breast milk. Int J Gynaecol Obstet. 1987;25 (Suppl):115–127. doi: 10.1016/0020-7292(87)90401-2. [DOI] [PubMed] [Google Scholar]
- Meng Y. X., Jiang H. Y., Chen A. J., Lu F. Y., Yang H., Zhang M. Y., Shen K. Y., Sun D. L., Shao Q. X., Fotherby K. Hemostatic changes in women using a monthly injectable contraceptive for one year. Contraception. 1990 Oct;42(4):455–466. doi: 10.1016/0010-7824(90)90052-w. [DOI] [PubMed] [Google Scholar]
- Meng Y. X., Jiang H. Y., Lu F. Y. The effects of long-term using once-a-month injectable contraceptive norethisterone enanthate/estradiol valerate on coagulation in the Chinese. Thromb Haemost. 1990 Dec 28;64(4):548–549. [PubMed] [Google Scholar]
- Oriowo M. A., Landgren B. M., Stenström B., Diczfalusy E. A comparison of the pharmacokinetic properties of three estradiol esters. Contraception. 1980 Apr;21(4):415–424. doi: 10.1016/s0010-7824(80)80018-7. [DOI] [PubMed] [Google Scholar]
- Recio R., Garza-Flores J., Schiavon R., Reyes A., Diaz-Sanchez V., Valles V., Luz de la Cruz D., Oropeza G., Perez-Palacios G. Pharmacodynamic assessment of dihydroxyprogesterone acetophenide plus estradiol enanthate as a monthly injectable contraceptive. Contraception. 1986 Jun;33(6):579–589. doi: 10.1016/0010-7824(86)90046-6. [DOI] [PubMed] [Google Scholar]
- SIEGEL I. Conception control by long-acting progestogens: preliminary report. Obstet Gynecol. 1963 Jun;21:666–668. [PubMed] [Google Scholar]
- Schiavon R., Benavides S., Oropeza G., Garza-Flores J., Recio R., Díaz-Sanchez V., Pérez-Palacios G. Serum estrogens and ovulation return in chronic users of a once-a-month injectable contraceptive. Contraception. 1988 Jun;37(6):591–598. doi: 10.1016/0010-7824(88)90005-4. [DOI] [PubMed] [Google Scholar]
- Sheffield W. H., Soule S. D., Herzog G. M. Cyclic endometrial changes in response to monthly injections of an estrogen-progestogen contraceptive drug. A histologic study. Am J Obstet Gynecol. 1969 Mar 15;103(6):828–835. doi: 10.1016/0002-9378(69)90582-1. [DOI] [PubMed] [Google Scholar]
- TAYMOR M. L., PLANCK S., YAHIA C. OVULATION INHIBITION WITH A LONG-ACTING PARENTERAL PROGESTOGEN-ESTROGEN COMBINATION. Fertil Steril. 1964 Nov-Dec;15:653–660. doi: 10.1016/s0015-0282(16)35411-5. [DOI] [PubMed] [Google Scholar]
- Toppozada M. The clinical use of monthly injectable contraceptive preparations. Obstet Gynecol Surv. 1977 Jun;32(6):335–347. doi: 10.1097/00006254-197706000-00001. [DOI] [PubMed] [Google Scholar]
- Treloar A. E., Boynton R. E., Behn B. G., Brown B. W. Variation of the human menstrual cycle through reproductive life. Int J Fertil. 1967 Jan-Mar;12(1 Pt 2):77–126. [PubMed] [Google Scholar]
- Wiemeyer J. C., Sagasta C. L., Roncales Mateo J. M., Lavarello A. C., Angel de Toro L. A., Salas Diaz R. Multicentred clinical study of the metabolic effect of the monthly injectable contraceptive containing dihydroxyprogesterone acetophenide 150 mg + estradiol enanthate 10 mg. Contraception. 1990 Jul;42(1):13–28. doi: 10.1016/0010-7824(90)90088-d. [DOI] [PubMed] [Google Scholar]
- Yussman M. A., Taymor M. L. Ovulation inhibition with a long-acting injectable contraceptive. IV. Return of reproductive function after discontinuation. Am J Obstet Gynecol. 1970 Nov 15;108(6):901–907. doi: 10.1016/0002-9378(70)90332-7. [DOI] [PubMed] [Google Scholar]
- von Kesserü E., Aydinlik S., Etchepareborda J. J., Kaufmann J. A multicentred, two-year, phase III clinical trial of norethisterone enanthate 50 mg plus estradiol valerate 5 mg as a monthly injectable contraceptive. Contraception. 1991 Dec;44(6):589–598. doi: 10.1016/0010-7824(91)90079-u. [DOI] [PubMed] [Google Scholar]