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PubMed1989

Study design for the Triphasic Randomized Clinical Trial.

The Triphasic Randomized Clinical Trial was a multicenter, open-label, controlled, 6-month study to determine the influence of three currently marketed triphasic oral contraceptives on lipid and carbohydrate metabolism, cyclic bleeding profiles, and other adverse drug experiences. The study protocol mandated four clinic visits: an initial visit during which study eligibility was determined, a second visit during which baselines were obtained for lipid and carbohydrate parameters, and visits at 3 and 6 months while taking the study drug. The study enrolled healthy women between the ages of 18 and 35 years who were within 20% of their ideal body weight and who had a history of normal and regular menstrual cycles. Patients were randomly assigned to one of three treatment groups: 51 patients to Tri-Levlen, 50 patients to Ortho-Novum 7/7/7, and 56 patients to Tri-Norinyl. The control group consisted of 49 patients using nonhormonal forms of birth control. Eighty-eight percent (181/206) of the patients completed all four visits and were considered evaluable for subsequent analyses.

Adolescent↗
PubMed1976

A new oral contraceptive based on the normophasic method.

62 women were treated for 554 cycles with normophasic oral contraceptive Fisioquens. A treatment cycle consists of 7 tablets of 0.05 mg ethinyloestradiol, followed by 15 tablets with a combination of 0.05 mg ethinyl-oestradiol and 1 mg lynestrenol. No pregnancies occurred. Both tolerance of the preparation and cycle control were good. Irregular bleeding occurred sporadically. Various side-effects diminished during treatment and even disappeared completely. Fisioquens appears to be a reliable contraceptive with a minimum of side-effects.

Adult↗
PubMed1986

Endometrial morphology during a normophasic and a triphasic regimen: a comparison.

It is expected that cycle control during oral contraceptive regimens may be correlated with the pattern of gradual endometrial maturation. Therefore the objective of the present study was to investigate the endometrial histology during a normophasic and a triphasic preparation. Biopsies were obtained at different intervals in the second treatment cycle from 21 women taking a triphasic pill and from 21 women taking a normophasic pill. The morphology of the endometria during the two regimens was evaluated and compared, as well as with the normal cycle histology. The study showed an early progestational effect and a rather hypoplastic growth during the triphasic regimen. The normophasic preparation was characterised by a better development and a more balanced glandular growth in proportion to the stroma, imitating the normal physiological mucosal changes very closely. From these observations it is concluded that a more reliable cycle control may be achieved by the use of this normophasic oral contraceptive as compared with the triphasic pill.

Adult↗
PubMed1993

The relationship between mood and sexuality in women using an oral contraceptive as a treatment for premenstrual symptoms.

This study investigated the effects of a triphasic oral contraceptive (OC) on mood and on sexual interest in a group of 45 women with premenstrual complaints. Subjects made daily ratings of mood and sexual interest for one baseline cycle and were then randomly assigned to receive either placebo or OC for 3 mo. Women who received the OC reported decreased sexual interest during the menstrual and postmenstrual phases of the cycle. The predominant effect of both the OC and the placebo on mood was one of improvement, particularly during the premenstrual phase. There was little evidence of co-variation of mood and sexual interest in either group. Although the mechanism for the adverse effects of the OC on levels of sexual interest in unknown, it is clear that this effect was not simply a consequence of pill-induced negative mood change. The findings provide evidence that mood and sexual desire are dissociable and suggest that OCs can have direct effects on women's sexuality.

Adolescent↗
PubMed1979

A new and sensitive method for quantifying and comparing the biological potency of varius estrogens in man.

The serum level of an estrogen-inducible plasma protein was followed by a radioimmunoassay in groups of women during treatment with various estrogens. After an initial increase, the mean value for the serum concentration was stable. The plateau level after six months of treatment was taken as a parameter of estrogenic potency. Eleven different hormonal preparations were compared and an estrogen index was constructed.

Contraceptives, Oral, Sequential↗
PubMed1981

[Hypophyseal reaction state during oral contraceptiva (author's transl)].

In 5 normocyclic women, firstly taking a conventional oral contraceptive, Neogynon (50 mcg EE + 250 mcg levo-norgestrel) for 6 months, the levels of LH, 17 beta-E2 and progesterone did not rise after changeover to a dose-reduced pill, Microgynon 30 (30 mcg EE + 150 mcg levo-norgestrel). This fact indicates maintained central suppression. Examination of the hypothalamic-hypophyseal axis by the Gn-RH test (50 mcg) with Microgynon 30 showed negative results during the first treatment cycle in 13 out of 18 women. In the 6th treatment cycle only 7 Gn-RH non-reactive women were observed and after stimulation with 100 mcg Gn-RH only 5 women remained with negative Gn-RH tests. Of the 20 women who took conventional oral contraceptives over a period of 6 months to 6 years (7 took Eugynon: 50 mcg EE + 500 mcg D,L-norgestrel, 5 Lyndiol: 75 mcg mestranol + 2.5 mg lynoestrenol, 8 Neogynon, only one from the Neogynon group showed a positive result. On the other hand there was a positive reaction in 4 out of 7 women using the two step dose-reduced preparation Sequilar (11 tablets of 50 mcg EE + 50 mct levo-norgestrel and 10 tablets of 50 mcg EE + 125 mcg levo-norgestrel).

Adult↗
PubMed1994

Efficacy and safety of a monophasic and a triphasic oral contraceptive containing norgestimate.

Both monophasic and triphasic formulations of ethinyl estradiol plus norgestimate, a progestin with marked progesterone-receptor affinity and minimal androgen-receptor affinity, have been evaluated in numerous clinical studies designed to determine if norgestimate's receptor-binding profile provides enhanced safety without a reduction in efficacy. To date clinical trials have shown that both formulations of ethinyl estradiol/norgestimate offer contraceptive efficacy equivalent to that of other oral contraceptives. Monophasic ethinyl estradiol/norgestimate was associated with an incidence of breakthrough bleeding and spotting similar to that of monophasic ethinyl estradiol/norgestrel and an incidence of amenorrhea less than that of ethinyl estradiol/norgestrel. Cycle control with triphasic ethinyl estradiol/norgestimate was similar to that with monophasic ethinyl estradiol/norgestimate. Weight gain and elevated blood pressure were insignificant in clinical trials with both fixed-dose and phasic ethinyl estradiol/norgestimate formulations. Perhaps of greatest importance, both monophasic and triphasic ethinyl estradiol/norgestimate formulations consistently showed favorable impact on metabolic parameters, including elevations in serum high-density lipoprotein cholesterol, and reductions in the low-density lipoprotein/high-density lipoprotein ratio, the parameter considered most sensitive for atherosclerotic risk. Both monophasic and triphasic ethinyl estradiol/norgestimate formulations were associated with minimal and clinically neutral effects on carbohydrate metabolism.

Contraceptives, Oral, Combined↗
PubMed1985

A randomized cross-over comparison of two low-dose oral contraceptives upon hormonal and metabolic parameters: I. Effects upon sexual hormone levels.

The effect of a low-dose triphasic oral contraceptive (OC) containing ethinyl estradiol and levonorgestrel (EE/NG) upon serum levels of endogenous sexual hormones was compared to that of a preparation containing EE and desogestrel (EE/DG). Blood samples were taken on Day 6, 11, 21, and 28 of a control cycle and of the third cycle of treatment with either the EE/NG or EE/DG preparation (11 volunteers each). After a washout period of 3 months, the contraceptives were changed in a cross-over fashion. Blood samples were again taken on Day 6, 11, 21, and 28 of the third washout cycle and the third treatment cycle. There was no significant suppression of serum LH and FSH during treatment with EE/NG and EE/DG except on Day 21, while estradiol levels were significantly lowered. Similar to the gonadotropin concentrations, the estrogen levels showed great individual variations; although they were depressed in the majority of the women, there was a considerable stimulation of follicular activity in 36% of the women under EE/NG and 18% under EE/DG. Both EE/NG and EE/DG suppressed significantly serum progesterone, testosterone, and DHEA-S, while prolactin was unaffected. In three cases an escape ovulation seemed to have occurred, but no pregnancy was observed. The spottings (8/22 women) and breakthrough bleedings (6/22 women) did not correlate with the serum levels of estradiol. The results indicate that the suppression of gonadotropin secretion during treatment with low-dose OC is a time-dependent process which in some women may be at or below the threshold of safe ovulation inhibition.

Adult↗
PubMed1991

Single and multiple administration of a new triphasic oral contraceptive to women: pharmacokinetics of ethinyl estradiol and free and total testosterone levels in serum.

Ethinyl estradiol is part of almost every combined oral contraceptive, and its pharmacokinetic characteristics have been thoroughly investigated in numerous studies. However, little is known about its pharmacokinetics during long-term administration, as compared with single-dose administration. In this study 10 women received a triphasic formulation that contained ethinyl estradiol together with the progestin gestodene over one treatment cycle. Mean area under the curve values of ethinyl estradiol were significantly higher on the last treatment day, as compared with the corresponding values obtained from the same women after single-dose administration. However, the observed increase in area under the curve was within the range of pharmacokinetic accumulation, to be expected on the basis of dosing interval and terminal half-life. Another point of interest was the effect of the triphasic preparation on testosterone concentrations in serum. Both total and free testosterone levels were suppressed by about 60% as compared with pretreatment values, and there was no correlation with corresponding sex hormone-binding globulin levels in the serum.

Adult↗
PubMed1987

Effects of three low-dose oral contraceptive formulations on lipid metabolism.

Three oral contraceptive preparations were studied in 60 healthy women. This randomized, comparative, baseline controlled study was designed to investigate the effects of the preparations on plasma lipids and lipoproteins. The following formulations were studied: a monophasic preparation containing ethinylestradiol and desogestrel (M-DSG) and two triphasic formulations containing ethinylestradiol and gestodene or levonorgestrel respectively (T-GSD and T-LNG). These preparations were studied for six treatment cycles. Total cholesterol and apoprotein B did not change in any group. Low density lipoprotein (LDL) cholesterol was significantly decreased in the groups of women treated with M-DSG and T-GSD respectively. No changes were observed in the T-LNG group. With M-DSG, significant increases were observed in high-density lipoprotein (HDL) cholesterol and HDL3 cholesterol, whilst HDL2 cholesterol did not change. With both T-GSD and T-LNG, no changes were observed in HDL cholesterol, whilst a significant increase in HDL3 cholesterol together with a trend to decrease in HDL2 cholesterol were observed. Apolipoprotein AI increased with the following ranking M-DSG greater than T-GSD greater than T-LNG. The LDL/HDL cholesterol ratio significantly decreased with both M-DSG and T-GSD. In the T-LNG group there was no change in this ratio. Triglycerides increased to the same extent in all treatment groups. As far as concerns the risk of arterial diseases, these three oral contraceptive formulations mostly induced negligible and/or partly favorable changes in plasma lipids and lipoproteins; however, the lipoprotein pattern during M-DSG treatment resulted better than during T-GSD, and the latter turned out to be better than during T-LNG.

Adolescent↗
PubMed1989

Lipid and lipoprotein changes in women taking low-dose, triphasic oral contraceptives: a controlled, comparative, 12-month clinical trial.

Effects on lipid/lipoprotein metabolism of two triphasic oral contraceptives, Triphasil (ethinyl estradiol/levonorgestrel) and Ortho-Novum 7/7/7 (ethinyl estradiol/norethindrone) were compared in a 12-month controlled, prospective clinical trial. The data indicate that use of both estrogen-progestin preparations were accompanied by increases in cholesterol, low-density lipoprotein and high-density lipoprotein3 cholesterol, apolipoproteins A1 and B, and triglycerides. Also observed were a decline in high-density lipoprotein cholesterol and greater decreases in high-density lipoprotein2 cholesterol levels; the latter were below the lower limits of laboratory's reference range. All other changes remained within clinically acceptable limits. There were no statistically significant differences between the test preparations, suggesting that the impact on lipid metabolism of the triphasic preparations Triphasil and Ortho-Novum 7/7/7 are similar and, given the dynamic balance between the various fractions, are unlikely to impart an adverse cardiovascular risk.

Adult↗