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Acta Med Hung. 1986;43(2):97-102.
Clinical and endocrine effects of long-term hormonal contraception.

Balogh A.

Clinical effectiveness and side effects of a biphasic oral hormonal contraceptive preparation (levonorgestrel /LNG/ 10 X 0.05 mg+ + 11 X 0.125 mg, ethinyl oestradiol /EO/ 21 X 0.05 mg) were compared with the effect of a classical high fixed dose combination pill (LNG 21 X 0.25 mg, EO 21 X 0.05 mg). The biphasic pill was used by 121 women during 1844 cycles, while the fixed dose pill was used by 142 women during 1940 cycles. In the comparison with the life table method, termination of pill use for medical reasons and loss to follow up proved to be significantly different in favour of the biphasic pill.

PIP: To collect data on clinical and laboratory effects of the oral contraceptives (OCs) marketed in Hungary, a prospective study was initiated in January 1983. Patient data were collected in regular intervals using standard statistical forms. During the first 2 years of the study, data were collected on 1256 women. A complete segment of the data was selected to be reported in this paper and included 1844 cycles of 121 women using a biphasic OC compared to 1940 cycles of 142 women using a classical formulation pill. The biphasic preparation was characterized by a very low levonorgestrel content with an average ethinyl estradiol dose; the reference preparation was a relatively high dose classical OC. No biologically significant difference was found between hormone and receptor levels. The basis of the comparison of the 2 preparations was the termination of OC use in the 2 groups as a function of time. The primary reasons for stopping administration of these preparations were unwanted pregnancy, medical reasons, critical age above 35, planned pregnancy, and other personal reasons. The difference between the 2 groups proved significant according to the life table method only in the category of medical reasons. Slightly more patients were lost to followup in the higher dose group. In the category of medical reasons, digestive tract complaints like nausea, vomiting, menstrual bleeding anomalies, too frequent bleeding-spotting, episodes of amenorrhea, weight gain, psychic disturbances, headache, breast tenderness, and swelling were prominent. These symptoms were most frequent in the first 3-4 months of OC use. The difference was due to the significantly higher rate of amenorrhea/hypomenorrhea, weight gain, and headache in the high dose monophasic pill group. The biphasic pill group was characterized by a slightly higher rate of gastrointestinal complaints and breast swelling. The overall difference favored the latter preparation. The biphasic OC did not cause a thrombotic change in homeostasis despite the fact that it was estrogen dominated. The basal levels of luteinizing hormone and follicle stimulating hormone were less affected in the biphasic OC users compared to the classical formulation OC users. Estradiol levels did not change significantly. The inhibition of ovulation was about the same with both treatment regimens.

online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=3588164&dopt=Abstract

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J Reprod Med. 1987 Aug;32(8):592-6.
Planned Parenthood experience with triphasil.

Hanson MS, Stewart GK, Bechtel RC, Turan ES.

Planned Parenthood of Minnesota, Minneapolis 55404.

Triphasil, a low-dose combination oral contraceptive containing levonorgestrel and ethinyl estradiol, was tested in four Planned Parenthood clinics on 317 women between 18 and 34 years of age (mean, 23) for a total of 4,692 cycles, or 361 woman-years of usage. Approximately half these volunteers (165) were nulligravidas, and 309 (97.5%) were white. Despite instructions on proper tablet usage, there were 416 cycles (8.9%) in which one or more tablets were missed. Only one pregnancy occurred, in a cycle in which a total of four tablets was missed, for an uncorrected Pearl index of 0.28 pregnancies per 100 woman-years of usage. No pregnancy resulted from method failure, indicating a 100% efficacy rate for Triphasil when taken properly. The mean length of the menstrual cycle with Triphasil was 27.9 days; the mean length of menses, 4.4 days; and the mean latency period, 2.1 days. Menstrual flow was average in 64.1% of the subjects, light in 34.1%, heavy in 1.3% and variable in 0.5%. Amenorrhea during the tablet-free interval occurred in only 0.6% of the 4,692 cycles in which Triphasil was used. Breakthrough bleeding occurred in 6.9% of first cycles and 3.2% of total cycles; spotting, in 10.7% of first cycles and 4.4% of total cycles. Other symptoms that occurred with an incidence of greater than or equal to 1% were acne (1.0%), appetite increase (1.2%), breast discomfort (2.8%), breast enlargement (1.3%), gastrointestinal symptoms (1.7%), simple headache (1.4%) and nausea (1.1%). A total of 44 women (13.9%) discontinued treatment for medical reasons.(ABSTRACT TRUNCATED AT 250 WORDS)

online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=3656299&dopt=Abstract

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Acta Endocrinol (Copenh). 1987 Sep;116(1):145-9.
Urinary melatonin, LH, oestradiol, progesterone excretion during the menstrual cycle or in women taking oral contraceptives.

Brun J, Claustrat B, David M.

Service de Radiopharmacie et Radioanalyse, Centre de Medecine Nucleaire, Hopital Neuro-Cardiologique, B.P. Lyon Montchat, France.

Nocturnal urinary excretion of melatonin, LH, progesterone and oestradiol was measured by radioimmunoassay in nine normal women during a complete cycle. In addition, these hormonal excretions were studied in two women taking an oral contraceptive. A high within-subject coefficient of variation was observed for melatonin excretion in the two groups. In the nine normal cycling women, melatonin excretion was not decreased at the time of ovulation, but was significantly increased during the luteal phase compared with that of the follicular phase (P less than 0.01). These data are consistent with a positive relationship between melatonin and progesterone during the luteal phase. In the two women under an oral contraceptive, melatonin excretion was found within the same range as for the other nine. The results are discussed in terms of pineal investigation in human.

online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=3661054&dopt=Abstract

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