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Results for “Oral Contraceptives, Combined”

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At least 19 recordsLinked to original sources
PubMed2000

An open-label, multicenter study to evaluate Yasmin, a low-dose combination oral contraceptive containing drospirenone, a new progestogen.

This open-label, multicenter study evaluated the efficacy, safety, and cycle control of Yasmin, a new low-dose, monophasic oral contraceptive containing the unique progestogen drospirenone (DRSP) 3 mg and ethinyl estradiol (EE) 30 microg. DRSP is a synthetic progestogen that has antiandrogenic and antimineralocorticoid effects. In this study, 326 women were evaluated and 220 (67%) completed all 13 treatment cycles. The corrected Pearl Index was 0. 407. Of the 151 subjects who experienced intermenstrual bleeding at any time during the study, the majority (64%) had bleeding during only one or two pill cycles. Breakthrough bleeding without spotting occurred in 1% of all cycles, spotting without breakthrough bleeding in 9.3% of all cycles, and breakthrough bleeding with spotting in 3% of all cycles. Amenorrhea was observed in 3% of all cycles. In all, 20 subjects (6%) discontinued participation in the study because of adverse events. No serious adverse events related to the study drug were reported. No clinically significant changes in weight, blood pressure, or lipids were reported. The impact of the new progestogen DRSP on the women's self-perception of menstrual health was also evaluated. Subjects reported that symptoms of water retention, negative affect, and increased appetite significantly improved at cycle 6 from baseline. This study demonstrates that Yasmin is an effective oral contraceptive that is safe and well tolerated.

Adolescent↗
PubMed2004

Ex vivo analysis of HIV-1 co-receptors at the endocervical mucosa of women using oral contraceptives.

Combined oral contraceptives may alter the microenvironment of the female genital tract and, thus, influence susceptibility of endocervical cells to HIV-1 transmission. The mechanism for this effect is unknown but might involve combined oral contraceptive up-regulation of chemokine receptors on CD4+ endocervical cells. We measured chemokine co-receptor (CCR5 and CXCR4) expression on cervical intraepithelial CD4+ T lymphocytes, macrophages and dendritic cells using flow cytometry in 32 healthy women, 16 of whom were combined oral contraceptive users and 16 non-users. All women tested negative for sexually transmitted infections. Combined oral contraceptive users showed a higher proportion of CCR5+ CD4+ T lymphocytes compared with combined oral contraceptive non-users (P < 0.05). However, expression of both co-receptors on cervical intraepithelial macrophages and dendritic cells was no different between the two groups. Up-regulation of CCR5 on cervical intraepithelial CD4+ T lymphocytes offers a potential explanation by which women receiving combined oral contraceptives may be at increased risk of HIV transmission.

Adult↗
PubMed1990

Gestodene: clinical experience with an innovative progestogen used in a combination oral contraceptive preparation.

The contraceptive efficacy, tolerance, and safety of a new monophasic oral contraceptive that combines 75 mcg gestodene (delta-15- levonorgestrel) and 30 mcg ethinyl estradiol were studied in 75 women (944 cycles) currently at risk for pregnancy. 20 women were nulliparous. No woman became pregnant during the trial, nor were vital signs of body weight affected by the drug. Cycle control was excellent, with no bleeding irregularities in 92% of the cycles. Serious complications did not occur. The low incidence of side effects, e.g. headache (9%) and breast tenderness (8%), indicated that the gestodene combination was well-tolerated. In a subgroup of 10 women, no changes in routine laboratory tests could be demonstrated after 12 cycles of treatment.

Belgium↗
PubMed1992

Hormone levels and anogenital swelling of female chimpanzees as a function of estrogen dosage in a combined oral contraceptive.

A combined oral contraceptive consisting of ethinyl estradiol (EE2) in three dosages (50, 100, and 400 micrograms) and norethindrone (0.5 mg) was given to female chimpanzees to determine the effect on endogenous sex hormone levels and anogenital swelling. Serum levels of EE2 increased with increasing dosages of EE2, estradiol decreased, and luteinizing hormone, progesterone and testosterone were maintained at approximately midfollicular phase levels. Urinary levels of EE2 glucuronide increased with the increasing dosages of EE2, whereas estrone and pregnanediol glucuronide were essentially undetectable. The cyclic increase in female anogenital swelling was abolished when the norethindrone was combined with 50 micrograms of EE2 and relatively constant and low levels of swelling were recorded. Relatively constant but successively higher levels of swelling were recorded when the norethindrone was combined with the higher dosages of EE2. These effects of oral contraceptives on female genital tissues are relevant to our laboratory studies of sexual behavior in chimpanzees given oral contraceptives and could also have implications for women taking oral contraceptives.

Anal Canal↗
PubMedDate not supplied

Ovarian consequences of the transient interruption of combined oral contraceptives.

The combined oral contraceptive pill is an efficient means of contraception. It acts at different levels of the genital tract. Despite its efficiency, it is universally suggested that patients take the pill at regular daily intervals. Little attention has been given to the question of what happens if you miss the pill one day or more. A study was undertaken to evaluate the consequences of pill misses at different times of the cycle. Forty-seven young, healthy, normally menstruating patients voluntarily enrolled. All were given Cilest (ethinyl estradiol 35 micrograms and norgestimate 250 mg, Cilag France) for 21 days without any misses. Then, after a 7-day interval, they were prescribed one (group 1), two (group 2), three (group 3) or four days of pill misses, to occur respectively on day 1 (group a), 6 (group b), 12 (group c) or 18 (group d) of a new 21 day cycle; supplementary contraceptive means were recommended. Four patients had no miss prescribed and served as controls. Ovarian function was evaluated with daily estrogen measurements (E1 + E2 enzymatic dosage, BioMérieux, France) and ultrasound examinations. When required, because of significant increase in estrogen or because of follicular growth detected on ultrasound, LH and progesterone were measured. None of the patients experienced a normal ovulation. Four patients (1 control, 1 from group 2a, and 2 from group 3a) had a significant increase in estrogen levels and had a follicular image on ultrasounds. One of them (group 3a) had a follicular rupture, but none had a LH surge or increase in progesterone.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1992

Ovarian consequences of the transient interruption of combined oral contraceptives.

The combined oral contraceptive pill is an efficient means of contraception. It acts at different levels of the genital tract. Despite its efficiency, it is universally suggested that patients take the pill at regular daily intervals. Little attention has been given to the question of what happens if you miss the pill one day or more. A study was undertaken to evaluate the consequences of pill misses at different times of the cycle. Forty-seven young, healthy, normally menstruating patients voluntarily enrolled. All were given Cilest (ethinyl estradiol 35 micrograms and norgestimate 250 mg, Cilag France) for 21 days without any misses. Then, after a 7-day interval, they were prescribed one (group 1), two (group 2), three (group 3) or four days of pill misses, to occur respectively on day 1 (group a), 6 (group b), 12 (group c) or 18 (group d) of a new 21 day cycle; supplementary contraceptive means were recommended. Four patients had no miss prescribed and served as controls. Ovarian function was evaluated with daily estrogen measurements (E1 + E2 enzymatic dosage, BioMérieux, France) and ultrasound examinations. When required, because of significant increase in estrogen or because of follicular growth detected on ultrasound, LH and progesterone were measured. None of the patients experienced a normal ovulation. Four patients (1 control, 1 from group 2a, and 2 from group 3a) had a significant increase in estrogen levels and had a follicular image on ultrasounds. One of them (group 3a) had a follicular rupture, but none had a LH surge or increase in progesterone.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1999

Activity of the pituitary-ovarian axis in the pill-free interval during use of low-dose combined oral contraceptives.

This study was performed to evaluate pituitary-ovarian recovery in the pill-free interval during use of three low-dose combined oral contraceptives (COC). Either the estrogen component or the progestin component was comparable in the study groups, to evaluate their relative influence. Serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), and estradiol (E2) levels were measured and follicle number and size estimated by transvaginal sonography daily during the 7-day pill-free interval in 44 healthy volunteers using three different low-dose oral contraceptives. Healthy volunteers were enrolled using 20 micrograms ethinyl estradiol (EE) + 75 micrograms gestodene (GSD) (Harmonet, Wyeth-Lederle; n = 15), 20 micrograms EE + 150 micrograms desogestrel (DSG) (Mercilon, Organon n = 17), or 30 micrograms EE + 150 micrograms DSG (Marvelon, Organon, n = 12) given according to the usual regimen of one tablet daily during 3 weeks and 1 week pill-free interval. No ovulations were observed. Pituitary hormones were not statistically significantly different at the beginning of the pill-free interval between the study groups. FSH concentrations were significantly higher at the end of the pill-free interval in the 30 micrograms EE group compared with both 20 micrograms EE groups (7.0 [0.6-12.4] IU/L vs 4.9 [1.4-6.1] IU/L and 4.5 [2.4-7.4] IU/L; p = 0.001). In both 20 micrograms EE groups, a single persistent follicle (24 and 28 mm) was present in one subject. Follicle diameters were statistically significantly smaller at the beginning and at the end of the pill-free period in the 30 micrograms EE group compared with both 20 micrograms EE study groups. Dominant follicles (defined as follicle diameter > or = 10 mm) were observed at the end of the pill-free interval in both 20 micrograms EE groups (in 27% and 18% of women, respectively) but not in the 30 micrograms EE group. Finally, the area-under-the-curve for E2 was statistically significantly lower in the 30 micrograms EE group compared with both 20 micrograms EE groups. In conclusion, the EE content rather than the progestin component in the studied COC determined the extent of residual ovarian activity at the beginning of the pill-free interval. Dominant follicles were encountered only in the 20 micrograms EE study groups.

Adolescent↗
PubMed2002

Androgen and lipid profiles in adolescents with polycystic ovary syndrome who were treated with two forms of combined oral contraceptives.

OBJECTIVE: To compare the effects of cyproterone acetate and desogestrel, as part of combined oral contraceptives, on lipid metabolism and hirsutism of adolescents with polycystic ovary syndrome (PCOS). DESIGN: Prospective randomized clinical trial. SETTING: Outpatient gynecology clinic (referral center) of a university. PATIENT(S): Twenty-eight adolescent girls with clinical and biological hyperandrogenism and six or less menses during the past 12 months. INTERVENTION(S): Group A (n = 14) received 0.15 mg of desogestrel plus 0.030 mg of ethinyl estradiol daily. Group B (n = 14) received 2 mg of cyproterone acetate plus 0.035 mg of ethinyl estradiol daily. Treatment was given for 21 days followed by a 7-day rest for a period of 12 months. MAIN OUTCOME MEASURE(S): Hirsutism and lipid profile were evaluated before initiation and at 3, 6, 9, and 12 months of treatment. Androgen profile was evaluated before and at 12 months of treatment. RESULT(S): A significant decline of the Ferriman-Gallway hirsutism score was observed from the sixth month of therapy in both groups. During therapy, the levels of testosterone, free testosterone, Delta(4)-androstenedione, and 17OH-progesterone decreased significantly, whereas sex hormone-binding globulin (SHBG) increased significantly in both groups. The level of total cholesterol and low density lipoprotein (LDL) cholesterol increased significantly, whereas high density lipoprotein (HDL) cholesterol and apolipoprotein A-I increased significantly from the third month of therapy in both groups. Total cholesterol/HDL cholesterol and LDL cholesterol/HDL cholesterol ratios remained unchanged. The levels of triglycerides increased significantly in the cyproterone acetate-treated group after the third month. CONCLUSION(S): Treatment of adolescent girls with PCOS with the two studied formulations is comparably effective in decreasing hirsutism and androgen levels. Both combined oral contraceptives are associated with an increase of total cholesterol, LDL cholesterol, and HDL cholesterol levels and no change of the total cholesterol/HDL cholesterol and LDL cholesterol/HDL cholesterol ratios. Treatment with the cyproterone acetate combined oral contraceptive is associated with a tendency toward increasing the levels of triglycerides.

Adolescent↗
PubMed2003

Skin patch and vaginal ring versus combined oral contraceptives for contraception.

BACKGROUND: The delivery of combination contraceptive steroids from a skin patch or vaginal ring offers potential advantages over those administered via the traditional oral route. The skin patch and vaginal ring could possibly require a lower dose due to increased bioavailability and improved user compliance. OBJECTIVES: The review's objective is to compare the contraceptive efficacy, cycle control, compliance, and safety of the contraceptive skin patch versus combination oral contraceptives and the contraceptive vaginal ring versus combination oral contraceptives. SEARCH STRATEGY: We searched the computerized databases MEDLINE, Popline, Cochrane Controlled Trials Register, EMBASE, and LILACS for trials of the contraceptive patch or the contraceptive ring. We also searched the references of the publications identified for inclusion. We contacted the manufacturers of the skin patch and the contraceptive ring in an attempt to identify published or unpublished trials that we might have missed. SELECTION CRITERIA: All randomized controlled trials in any language comparing the combination contraceptive skin patch with a combination oral contraceptive or the combination contraceptive vaginal ring with a combination oral contraceptive. DATA COLLECTION AND ANALYSIS: Titles and abstracts identified from the literature searches were assessed for potential inclusion. Data were abstracted by both the primary and second reviewers to ensure accuracy and were entered into RevMan 4.1. Peto odds ratios with 95% confidence intervals were calculated for all outcomes. Six- and 13-cycle Kaplan-Meier pregnancy rates were also entered into "Additional Tables." No sensitivity analyses were conducted since the eligible trials used different comparison oral contraceptives. The trials were critically appraised by examining the following factors: the study design; blinding; randomization method; group allocation concealment; exclusions after randomization; loss-to-follow-up; and early discontinuation. MAIN RESULTS: We found three trials of the skin patch and no eligible randomized controlled trials of the combination contraceptive vaginal ring. The six-cycle and 13-cycle Kaplan-Meier cumulative probabilities of pregnancy showed that the combination contraceptive skin patch was similar to the control combination oral contraceptive in contraceptive efficacy. One trial found that patch users discontinued early from the trial more often than oral contraceptive users (OR 1.6; 95% CI, 1.3-2.0) but a second trial found no differences in discontinuation between the groups (OR 2.6; 95% CI, 1.0-6.7). Patch users had more self-reported cycles of compliance than oral contraceptive users; the odds ratio of compliance was 2.1 (95% CI, 1.8-2.3). Patch users were more likely to report breast discomfort than oral contraceptive users with an odds ratio of 3.1 (95% CI, 2.3-4.2). The remaining commonly reported adverse events did not differ by group assignment. One trial found that women assigned to use the patch were more likely to discontinue due to adverse events than those assigned to use the oral contraceptive (OR 2.3; 95% CI, 1.6-3.3), but a second trial found no difference (OR 2.8; 95% CI, 0.7-11.3). Few serious adverse events occurred that were considered possibly or likely related to the use of the patch or oral contraceptive. REVIEWER'S CONCLUSIONS: The randomized controlled trials comparing a combination contraceptive skin patch to a combination oral contraceptive showed similar efficacy rates for the two methods. The patch group had better self-reported compliance than the oral contraceptive group. On the other hand, breast tenderness was more common among those randomized to the patch. The patch might lead to early discontinuation (overall and due to adverse events), but the trial results on this outcome were mixed. No conclusions can be drawn regarding the vaginal ring as no eligible trials were available.

Contraceptive Agents, Female↗
PubMed1987

Metabolic effects of oral contraceptives.

Combination oral contraceptives (OCs) are probably not an independent risk factor for cardiovascular disease but through their metabolic actions, may partly amplify the effects of known risk factors for cardiovascular disease. This review of the literature and our own data indicate that use of high-dose, progestogen-dominant OCs induces a potentially atherogenic lipoprotein profile (high low-density lipoprotein-cholesterol:high-density lipoprotein-cholesterol ratio), mostly attributable to the antiestrogenic action of the progestogen content of these OCs. In contrast, lower-dose combination OCs with reduced amounts of progestogens and slight estrogen dominance, either monophasic or multiphasic, produce strikingly fewer adverse effects on lipoproteins. Moreover, use of low-dose, as opposed to high-dose, OCs results in almost unchanged glucose tolerance, marginally increased or unchanged insulin and glucagon responses to glucose, and probably unchanged levels and activity of peripheral insulin receptors. Further in-depth studies of low-dose OC formulations are mandatory to ascertain reduced metabolic risk of these OCs.

Cardiovascular Diseases↗
PubMed2006

Risk of cancer development in relation to oral contraception.

Combined oral contraceptives (COCs) are among the most widely used effective and reversible means of family planning. Their beneficial effects are well documented, but many questions are still raised concerning a possible association between the use of COCs and the development of cancer. The authors provide a broad and up-to-date review of the literature regarding the relation between COC use and carcinogenesis in different organs. Studies have not unequivocally confirmed that such a relation exists with regard to breast cancer. Much research focused on the influence COC use could have on the incidence of cervical cancer; most of it was analyzed by J. Smith and co-workers. These authors confirmed the existence of a weak relation between COC use and the development of cervical carcinoma, especially in women using COCs for longer periods. Ovarian carcinoma has the worst prognosis of all cancers of reproductive organs in women. The risk of developing ovarian cancer in women using COCs is at least 40% smaller than in other women; the degree of protection given by COCs is directly proportional to the duration of use of this form of contraception. Reliable scientific data prove convincingly that the risk of endometrial cancer is smaller in women who used COCs than in women who never took them.

Breast Neoplasms↗
PubMed1999

Decreased plasma tissue factor pathway inhibitor in women taking combined oral contraceptives.

Use of combined oral contraceptives (OC) is associated with a significant risk of thrombosis. The mechanisms of this effect are not clearly defined. Tissue factor pathway inhibitor (TFPI) is a circulating anti-coagulant that inhibits the earliest steps in activation of the extrinsic coagulation pathway. It plays a central role in control of coagulation but its contribution to the thrombotic risk associated with OC has not been assessed. Plasma TFPI antigen and activity, factor VIIa, prothrombin fragments 1&2, von Willebrand antigen, fibrinogen, and low density lipoprotein cholesterol were measured by standard assays in women taking OC (aged 16 to 45 years, n = 40) and age-matched women not taking OC (controls, n = 40). Plasma TFPI antigen did not vary significantly across the menstrual cycle in controls. Women on OC had a 25% reduction in plasma TFPI antigen (median 51.0 ng/ml; 95% confidence intervals [CI] 37.5 to 85.5; control 68.0 ng/ml, CI 61.0 to 95.0; P < 0.001) and a 29% reduction in TFPI activity (78.5 U/ml, CI 57.5 to 107.5; control 111.0 U/ml, CI 79.5 to 171.0; P < 0.001) compared to controls. Plasma factor VIIa activity and prothrombin fragments 1&2 were also significantly increased in women using OC (both P < 0.001), indicating activation of the extrinsic coagulation pathway. These results demonstrate that normal cyclic variations in estrogen and/or progesterone do not significantly alter plasma TFPI levels. However, estrogens and/or progestogens in OC result in activation of the extrinsic coagulation pathway and significantly reduce plasma TFPI, its major circulating inhibitor. Reduced plasma TFPI levels may underlie the thrombotic effects of OC.

Adolescent↗