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PubMed1995

Androgenic effects of oral contraceptives: implications for patient compliance.

Androgenic disorders have many negative physical effects. These effects may be caused by excess androgen (exogenous or endogenous) or by end-organ sensitivity to normal levels of androgens. Historically, androgenic progestins in oral contraceptives have also been associated with some of these negative effects. The most apparent signs of androgen excess are the external manifestations, including oily skin, acne, hirsutism, android obesity, and androgenic alopecia. Of equal concern are the potential metabolic disturbances associated with hyperandrogenicity. Unfavorable lipid profiles and increased incidence of diabetes and hypertension are very real threats to long-term health. In oral contraceptive users, external manifestations of androgenicity often lead to poor compliance, decreased efficacy, and discontinuation of oral contraceptive use, especially in the younger patient. With the introduction of the newer oral contraceptive formulations containing less androgenic progestins (norgestimate, desogestrel, gestodene), androgen-related effects have been reduced and better compliance is anticipated.

Androgens↗
PubMed1995

The role of oral contraceptives in the treatment of hyperandrogenic disorders.

The clinical manifestations associated with hyperandrogenism, such as hirsutism and acne, are disturbing to most patients. In addition to correcting androgen-related problems, concerns such as contraception or other metabolic problems (for example, lipid/lipoprotein abnormalities, diabetes, hypertension) associated with these disorders and the effects of unopposed estrogen on the endometrium also need to be considered. Oral contraceptives are a therapeutic modality that may address these multiple problems. The potential mechanisms of action by which oral contraceptives correct excess androgen states include gonadotropin suppression, reduction of circulating androgens, increased androgen binding, suppression of adrenal androgen secretion and inhibition of 5 alpha-reductase, and androgen receptor binding. In normal women, there is good evidence that these actions occur with the use of oral contraceptives. Among women with anovulatory hyperandrogenic states, such as polycystic ovary syndrome, the response to oral contraceptives in each of these areas is somewhat more variable. However, oral contraceptive preparations that are more estrogen dominant appear to produce many of the desired effects. From a clinical standpoint, 60-100% of women with hirsutism improve on oral contraceptives; acne shows improvement in a high percentage of women as well. The use of oral contraceptives also reduces the risk of endometrial hyperplasia that may be associated with anovulatory states. Finally, current low-dose preparations containing the newer progestins (for example, norgestimate and desogestrel) appear to be either neutral, or perhaps beneficial, with respect to their metabolic impact.

Adrenal Glands↗
PubMed1994

New knowledge in the physiology of hormonal contraceptives.

The present review addresses some of the new knowledge regarding the physiology and mechanisms of action of hormonal contraceptives. Specific topics that are discussed include oral contraceptives, intravaginal rings, long-term contraception, gonadotropin-releasing hormone agonists and antagonists, and antiprogestins. It has been shown that in combined oral contraceptives, lower doses of the new progestins (desogestrel, norgestimate, and gestodene) can be used to inhibit ovulation compared with norethindrone and levonorgestrel. In addition, lower doses of ethinyl estradiol are now used with progestins. Estrogen has been added to intravaginal rings containing levonorgestrel or norethindrone acetate to reduce frequency of bleeding. A new ring containing 3-keto-desogestrel is under evaluation. The use of subdermal implants containing levonorgestrel is currently a popular and highly effective method of long-term contraception. Studies show that gonadotropin-releasing hormone agonists and antagonists can provide ovarian suppression, and antiprogestins such as RU486 effectively block the midcycle gonadotropin surge. These and other novel methods of hormonal contraception are still years away from general use.

Administration, Intravaginal↗
PubMed1999

Risk of venous thromboembolism with third-generation oral contraceptives: A review.

Recent data indicate that users of third-generation oral contraceptives, those containing the new progestins desogestrel, gestodene, and norgestimate, have 2 to 3 times the risk of venous thromboembolism faced by users of second-generation oral contraceptives. The risk of development of deep vein thrombosis was also found to be 2 to 5 times greater with a low-estrogen, desogestrel-containing oral contraceptive than with second-generation monophasic and triphasic preparations. Investigators point to an acquired resistance to the anticoagulation effects of activated protein C, the most common cause of hereditary thrombophilia, as a possible mechanism. The American College of Obstetrics and Gynecology's Committee on Gynecologic Practice reconfirms the increased risk of venous thromboembolism associated with third-generation progestins versus other progestins. Because the third-generation oral contraceptives may have benefit for some patients, however, it defers to the individual clinician's and patient's judgment regarding the use of a desogestrel-containing formulation (the only third-generation progestin available in the United States).

Clinical Trials as Topic↗
PubMed2000

Hemostatic effects of third- and second-generation oral contraceptives: absence of a causal mechanism for a difference in risk of venous thromboembolism.

Some observational studies have found a difference in the risk of nonfatal venous thromboembolism (VTE) with low-dose, oral contraceptives (OCs) containing desogestrel (DSG) or gestodene (GSD) and those containing levonorgestrel (LNG). However, this does not agree with current pathophysiological concepts. This review compares all 17 comparative studies on the hemostatic effects of DSG/GSD- and LNG- or norgestimate (NGM)-containing OCs, and comments on two recent cross-sectional studies on the effects of third- and second-generation OCs on activated protein C (APC) sensitivity. In the comparative studies, the only difference in hemostatic parameters between DSG/GSD- and LNG- or NGM-containing OC users was a tendency towards higher factor VII (FVII) levels with DSG/GSD OCs. Differential effects on APC sensitivity were observed with the endogenous thrombin generation potential (ETP) assay, but not with the classical APC resistance test. FVII is not a risk marker for VTE, but is affected by dietary fat, estrogens and androgens and may interfere with the ETP assay. As no differences in established VTE risk markers were observed, there is no plausible reason for a differential risk of VTE with DSG/GSD- and LNG-containing OCs. In fact, the lack of differences with regard to established risk markers of VTE gives further support to the findings of the most recent epidemiological studies, which have not found any difference in the risk of VTE between third- and second-generation OCs.

Causality↗
PubMed2001

Comparison of a novel norgestimate/ethinyl estradiol oral contraceptive (Ortho Tri-Cyclen Lo) with the oral contraceptive Loestrin Fe 1/20.

This multicenter study compared the contraceptive efficacy, cycle control, and safety of a new triphasic norgestimate (180/215/250 microg)/ethinyl estradiol 25 microg regimen (Ortho Tri-Cyclen Lo) (n = 1,723) with that of norethindrone acetate 1 mg/ethinyl estradiol 20 microg (Loestrin Fe 1/20) (n = 1,171). Healthy women were treated for up to 13 cycles. Demographics were similar between regimens. Contraceptive efficacy was comparable for Ortho Tri-Cyclen Lo and Loestrin Fe 1/20. The overall and method failure probabilities of pregnancy through 13 cycles were 1.9% and 1.5%, respectively, with Ortho Tri-Cyclen Lo and 2.6% and 2.4%, respectively, with Loestrin Fe 1/20. Breakthrough bleeding and spotting was reported by a significantly lower percentage of participants in the Ortho Tri-Cyclen Lo group compared with the Loestrin Fe 1/20 group. At representative Cycles 1, 3, 6, 9, and 13, breakthrough bleeding and spotting rates were 16.3, 11.5, 10.3, 7.9, and 7.7%, respectively, in the Ortho Tri-Cyclen Lo group and 34.9, 22.9, 22.2, 15.9, and 13.1%, respectively, in the Loestrin Fe 1/20 group. Compliance and safety data were similar for the two regimens.

Administration, Oral↗
PubMed2002

Contraceptives and cerebral thrombosis: a five-year national case-control study.

The object of this study was to assess the influence of oral contraceptives (OCs) on the risk of cerebral thromboembolic attacks (CTA) including thrombotic stroke and transitory cerebral ischemic attacks. A 5-year case-control study including all Danish hospitals was conducted. All women 15-44 years old suffering a first ever CTA during the period January 1, 1994 to December 31, 1998, were included. Controls were selected annually, 600 per year in 1994-1995, 1200 per year 1996-1998. Response rates for cases and controls were 88% and 90%, respectively. After exclusion of nonvalid diagnoses, pregnant women, and women with previous thrombotic diseases, 626 cases and 4054 controls were available for analysis. A multivariate matched analysis was performed. Controls were matched to cases within 1-year age bands. Adjustments were made for the following potential confounders: year, length of OC use, smoking, hypertension, migraine, family CTA, and years of schooling. There were 212 and 1208 current users of OCs among cases and controls, respectively. The risk of CTA among current users of OCs decreased significantly with decreasing estrogen dose (nonusers reference): OCs with 50 microg, 30-40 microg, 20 microg ethinyl estradiol (EE) and progestin-only pills implied adjusted odds ratios (ORs) (95% CI) of 4.5 (2.6-7.7), 1.6 (1.3-2.0), 1.7 (1.0-3.1), and 1.0 (0.3-3.0), respectively. Current users of OCs with second- (levonorgestrel or norgestimate) and third- (desogestrel or gestodene) generation progestins combined with 20-30 microg EE had ORs of CTA of 2.2 (1.6-3.0) and 1.4 (1.0-1.9), respectively. After correction for differences in estrogen dose, the third- to second-generation risk ratio was 0.6 (0.4-0.9; p = 0.01). In conclusion, high dose OCs and OCs with second-generation progestins were associated with the risk of CTA. The risk increased 2.5 times with estrogen dose increasing from 20 to 50 microg EE, and users of low-dose OCs with second-generation progestins had a 61% higher risk-association of CTA than users of OCs with third-generation progestins.

Adolescent↗
PubMed2002

Oral contraceptives and venous thromboembolism: a five-year national case-control study.

The objective of this study was to assess the influence of oral contraceptives (OCs) on the risk of venous thromboembolism (VTE) in young women. A 5-year case-control study including all Danish hospitals was conducted. All women 15-44 years old, suffering a first ever deep venous thrombosis or a first pulmonary embolism (PE) during the period January 1, 1994, to December 30, 1998, were included. Controls were selected annually, 600 per year in 1994-1995 and 1200 per year 1996-1998. Response rates for cases and controls were 87.2% and 89.7%, respectively. After exclusion of nonvalid diagnoses, pregnant women, and women with previous thrombotic disease, 987 cases and 4054 controls were available for analysis. A multivariate, matched analysis was performed. Controls were matched to cases within 1-year age bands. Adjustment was made for confounding influence (if any) from the following variables: age, year, body mass index, length of OC use, family history of VTE, cerebral thrombosis or myocardial infarction, coagulopathies, diabetes, years of schooling, and previous birth. The risk of VTE among current users of OCs was primarily influenced by duration of use, with significantly decreasing odds ratios (OR) over time: <1 year, 7.0 (5.1-9.6); 1-5 years, 3.6 (2.7-4.8); and >5 years, 3.1 (2.5-3.8), all compared with nonusers of OCs. After adjustment for confounders, current use of OCs with second- (levonorgestrel or norgestimate) and third- (desogestrel or gestodene) generation progestins when compared with nonuse resulted in ORs for VTE of 2.9 (2.2-3.8) and 4.0 (3.2-4.9), respectively. After adjusting for progestin types and length of use, the risk decreased significantly with decreasing estrogen dose. With 30-40 microg as reference, 20 and 50 microg products implied ORs of 0.6 (0.4-0.9) and 1.6 (0.9-2.8), respectively (p(trend) = 0.02). After correction for duration of use and differences in estrogen dose, the third/second-generation risk ratio was 1.3 (1.0-1.8; p <0.05). In conclusion, use of OCs was associated significantly to the risk of VTE. The risk among current users was reduced by more than 50% during the first years of use. The risk increased more than 100% with increasing estrogen dose, and the difference in risk between users of third- and second-generation OCs, after correction for length of use and estrogen dose, was 33%.

Adolescent↗
PubMed2003

The effects of seven monophasic oral contraceptive regimens on hemostatic variables: conclusions from a large randomized multicenter study.

We investigated the effects of ethinylestradiol dose (50, 30 and 20 microg) and progestogen type [desogestrel (DSG), gestodene (GSD), levonorgestrel (LNG) and norgestimate (NGM)] in oral contraceptives on 24 hemostatic variables. In a multicenter, randomized, comparative study, 707 healthy, nonsmoking, nulliparous women were treated for six cycles with one of the seven monophasic oral contraceptives tested. Significantly greater increases in prothrombin fragment 1+2 and factor VII (activity and antigen), were found in the DSG, NGM and GSD groups compared to the LNG group. Similarly, significantly lower levels of protein S (free and total) and increased APC-sr (endogenous thrombin potential based) were found in the same groups compared with the LNG group. In addition, the estradiol dose (50 vs. 30 microg) significantly influenced these parameters. All changes were within the normal range and have not been associated with an increased risk of venous thromboembolic event (VTE). However, raised levels of these variables are associated with prothrombotic states such as pregnancy. The significance of the haemostatic changes found in this study in relation to VTE risk remains to be determined, but results of this study probably cannot explain the differences in risk of VTE between OCs containing different progestogens.

Adult↗
PubMed1997

Estrogen and progestin components of oral contraceptives: relationship to vascular disease.

Recently, new information has been published about: a) the relationship between combination oral contraceptives (OCs), estrogen dose, cigarette smoking, and the risk of myocardial infarction (MI) and stroke; and b) the effect of different progestins on the risk of venous thromboembolism (VTE). We review the epidemiologic data. Regardless of age, in the absence of smoking, use of sub-50 micrograms OCs is not associated with any meaningful increase in risk of MI or stroke. If the small, statistically nonsignificant elevations in risk for these diseases are assumed (for the sake of argument) to be causal, then the incidence of MI and stroke associated with use of OCs containing less than 50 micrograms ethinyl estradiol (EE) would be approximately 2 per 100,000 per year. For women less than 35 years of age who do not smoke or do not have a history of hypertension, the risk would be even lower. Any woman over the age of 35 who smokes should be advised to use a non-estrogen or nonhormonal contraceptive. There are now two reports, from jick et al. and Lewis et al., that demonstrate that the relative risk of MI is certainly no greater for users of OCs containing desogestrel or gestodene than for users of OCs containing older progestins. In fact, both show reduced relative risks for the newer progestins compared to the older ones. With respect to progestins, four recent epidemiologic studies have indicated a twofold increased risk of nonfatal VTE with use of OCs containing desogestrel or gestodene compared with levonorgestrel. A fifth report, which showed an increased relative risk for norgestimate, is based on use among only 19 cases and 31 controls and is not statistically significant. As the authors themselves caution and as subsequent follow-up analyses and editorials conclude, these studies do not provide evidence for a cause-and-effect relationship between OCs containing desogestrel or gestodene, and VTE. The recommendation with respect to desogestrel- and gestodene-containing OCs is that no change in prescribing practices is warranted for either current or new-start patients. There is a growing body of evidence demonstrating that OCs containing 30 or 35 micrograms of EE have lower risks of MI, stroke, and VTE than higher dose OCs. However, there is no epidemiologic study that demonstrates a greater risk of vascular events among women using OCs containing 30 or 35 micrograms EE compared with preparations containing 20 micrograms EE. Users of sub-50 micrograms OCs of any age have no clinically meaningful increase in incidence of MI or stroke compared with non-OC users. This is also true for smokers under the age of 35 years who use OCs. However, smokers over the age of 35 years who use OCs still have an unacceptably high incidence rate of MI and stroke and should not use combination OCs. Sub-50 micrograms OCs of all types are associated with a small excess risk of VTE, about 15 per 100,000 events per year. Until there is biologic explanation of the twofold greater risk of VTE in users of OCs containing desogestrel or gestodene compared with users of those containing older progestins, this association should not be accepted as one of cause and effect.

Cardiovascular Diseases↗
PubMed1998

Newer oral contraceptives and the risk of venous thromboembolism.

Research on the relationship between venous thromboembolism and the progestagen content of combined oral contraceptives has pointed to an increase in risk associated with products containing desogestrel and gestodene. Although many biases must have been at play in these nonexperimental studies, the errors that have been suggested and examined are not of a sufficient magnitude to account for the observed results. The most plausible explanation of the available data is that combined oral contraceptives containing desogestrel and gestodene carry a very small risk of venous thromboembolism, which exceeds the even smaller risk carried by products containing levonorgestrel. The position of norgestimate is uncertain.

Contraceptives, Oral, Combined↗
PubMed1998

Oral contraceptives and venous thromboembolism. A case-control study.

To assess the influence of oral contraceptives (OC) on the risk for venous thromboembolism (VTE) in young women, a 5-year case-control study including all women 15-44 years old suffering a first deep venous thrombosis or a first pulmonary embolism from all Danish hospitals, along with 1200 control subjects during the period 1994-1995, was conducted. Of 586 patient and 1200 control subject questionnaires sent out, 523 patient (89.2%) and 1074 control (89.5%) questionnaires were returned with an agreement to participate. After exclusion of women with nonvalid diagnoses, women who were pregnant, and women with previous VTE or acute myocardial infarction (AMI), 375 patients and 1041 control subjects were available for analysis. Potential tested confounders included: body mass index, length of OC use, family history of VTE, AMI, or stroke, smoking habits, coagulopathies, diabetes, years of schooling, certainty of diagnosis, previous births, and treated hypertension during any pregnancy. A multivariate analysis was performed. Estrogen dose had no influence on the risk for VTE. The risk for VTE among current users of OC was primarily influenced by duration of use, with significantly decreasing odds ratios (OR) over time: < 1 year; 5.1 (3.1-8.5); 1-5 years; 2.5 (1.6-4.1); and > 5 years; 2.1 (1.5-3.1), all compared with those for nonusers of OC. This trend was still significant after adjustment for progestin types. Without adjustment for duration of use, current users of OC with second generation (levonorgestrel or norgestimate) and third generation (desogestrel or gestodene) progestins had OR of 1.8 (1.1-2.9) and 3.2 (2.3-4.4), respectively. After correction for duration of use, however, no significant differences were found between users of OC with different types of progestins. In conclusion, OC increase the risk for VTE significantly. The risk among current users of OC is primarily influenced by duration of use. No difference in risk was found according to estrogen dose, and the difference in risk between different types of progestins was not statistically significant after adjustment for duration of use.

Adolescent↗
PubMed1999

Clinical comparison of triphasic norgestimate/35 micrograms ethinyl estradiol and monophasic norethindrone acetate/20 micrograms ethinyl estradiol. Cycle control, lipid effects, and user satisfaction.

This six-cycle, multicenter, open-label, randomized study compared the clinical experience of two low-dose oral contraceptives (OC): a triphasic OC containing norgestimate (NGM) and 35 micrograms ethinyl estradiol (EE) (Ortho Tri-Cyclen) and a monophasic OC containing norethindrone acetate (NETA) and 20 micrograms EE (Loestrin Fe 1/20). Cycle control, lipid and androgen profiles, and user satisfaction were studied in new-start OC users (i.e., no prior use within 60 days). Breakthrough bleeding or breakthrough spotting (BTB/BTS) occurred in a significantly smaller percentage of NGM/EE users than NETA/EE users during each of six cycles (p < or = 0.002). The incidence of BTB/BTS ranged from 3.7% to 13.5% for NGM/EE users and from 23.5% to 49.7% for NETA/EE users. Significantly fewer NGM/EE users than NETA/EE users experienced absence of menses at cycles 2 through 6 (p < or = 0.003). The percentages of women having no menses at each cycle ranged from 0.9% to 4.7% for NGM/EE users and from 10.3% to 21.3% for NETA/EE users. NGM/EE users reported a significantly (p < 0.001) higher level of satisfaction with their OC at the end of six cycles than did NETA/EE users, but there was no significant difference in compliance, discontinuation rates, or adverse events between the two groups. NGM/EE produced a significantly (p < or = 0.001) greater beneficial effect on HDL-C, HDL2, and apo A-I than did NETA/EE. No statistically significant treatment differences were found for total cholesterol, LDL-C, triglycerides, or apo-B. Both OC increased sex hormone binding globulin and decreased free testosterone, but NGM/EE had a significantly greater effect (p < 0.009).

Androgens↗
PubMed1999

An open label, randomized study to evaluate the effects of seven monophasic oral contraceptive regimens on hemostatic variables. Outline of the protocol. Oral Contraceptive and Hemostasis Study Group.

Complementary to the epidemiological knowledge on the association between oral contraceptive use and the occurrence of venous thromboembolism, a study was designed to obtain more conclusive data regarding the effect of estrogen dose and progestogen type of oral contraceptives on risk markers for the occurrence of venous thromboembolism. The protocol for this multicenter, randomized, open label, parallel group, comparative study is outlined in the present article. A total of 730 healthy, nonsmoking, mulliparous women were treated for six cycles with one of the seven monophasic oral contraceptives tested in this study. The effects of progestogen type (desogestrel, gestodene, levonorgestrel, and norgestimate) and the effects of ethinyl estradiol dose (50, 30, and 20 micrograms) on various hemostatic variables was assessed, including the key components of the anticoagulant and fibrinolytic system, as well as the coagulation system. The primary outcome variables in the study were prothrombin fragment 1 + 2 and D-dimer.

Blood Coagulation↗
PubMed1999

Metabolic and fibrinolytic response to changed insulin sensitivity in users of oral contraceptives.

The fundamental role of insulin resistance for metabolic changes linked to cardiovascular disease and type 2 diabetes is increasingly recognized. Oral contraceptives (OC) may affect insulin sensitivity, and a detailed characterization hereof, as well as the secondary effects on related metabolic systems, are relevant in the evaluation of the risk of developing vascular disorders or diabetes in OC users. We studied insulin sensitivity index (S(I)), glucose effectiveness (S(g)), and insulin response in young, healthy women by frequently sampled intravenous glucose tolerance tests before and after randomization to 6 months of treatment with ethinyl estradiol in triphasic combination with norgestimate (n = 17) or gestodene (n = 20). Measurements of fasting triglycerides and antigen concentrations of tissue-type plasminogen activator (t-PA) and plasminogen activator inhibitor type 1 (PAI-1) were also included. Both compounds increased fasting plasma insulin and reduced S(i) but did not affect S(g). The relationships between S(i) and insulin response were unchanged. No consistent correlation between insulin sensitivity and triglycerides, t-PA, or PAI-1 were demonstrated before or during treatment. We conclude that the treatments were followed by a compensated decrease in insulin sensitivity that was unrelated to changes in triglycerides, t-PA, or PAI-1 antigen.

Adult↗
PubMed2002

Triphasic oral contraceptives: review and comparison of various regimens.

OBJECTIVE: To review and compare the risk-benefit profile of triphasic oral contraceptives with that of low-dose monophasic oral contraceptives. DESIGN: Literature on currently marketed triphasics and monophasics. PATIENT(S): Healthy women of reproductive age. MAIN OUTCOME MEASURE(S): Comparison of the rationale for development, composition, mechanism, efficacy, menstrual cycle control, side effects, health benefits, and risk-benefit profile. RESULT(S): All triphasics contain ethinyl estradiol (0.025-0.040 mg/d) and one of several progestins in doses (0.05-1.0 mg/d) related to their relative potencies, which are substantially lower overall (total dose) than those in monophasics. The triphasics are highly efficacious. In general, menstrual cycle control and side effects are similar in both types, but triphasics containing the newer progestins (desogestrel, gestodene, and norgestimate) have better cycle control and a reduced incidence of androgenic side effects compared with those with norethindrone or levonorgestrel. Both triphasics and monophasics have minimal effects on carbohydrate and lipid metabolism and hemostasis parameters, and therefore comparable low risks of coronary heart disease. The health benefits of triphasics and monophasics are similar and include decreased incidence of unwanted and ectopic pregnancies, ovarian cysts, endometrial and ovarian cancers, benign breast disease, and acute pelvic inflammatory disease; less menstrual blood loss and iron deficiency anemia; and lower frequency of irregular bleeding and menorrhagia. CONCLUSION(S): The risk-benefit profiles of both triphasics and monophasics are favorable and similar.

Contraceptives, Oral, Combined↗
PubMed1996

Laboratory criteria for menopause in women using oral contraceptives.

OBJECTIVE: To evaluate laboratory criteria for menopause in women talking oral contraceptives (OC). DESIGN: Prospective, uncontrolled pilot study. SETTING: San Francisco General Hospital, San Francisco, California, and Magee-Womens Hospital, Pittsburgh, Pennsylvania. PATIENTS: Twenty-eight menopausal women. INTERVENTIONS: Fourteen menopausal women received triphasic 35 micrograms ethinyl E2 and 180-215-250 micrograms norgestimate, and 14 menopausal women received monophasic 30 micrograms ethinyl E2-150 micrograms desogestrel. MAIN OUTCOME MEASURES: Serum FSH, LH, and E2 levels were evaluated on days 14 and 28 (day 7 of the pill-free interval) of the third cycle of pills. RESULTS: Twelve women in each group completed the study. Fifteen (62.5%) subjects still had a serum FSH < 30 mIU/mL (30 IU/L) on the 7th day of the pill-free interval of the third pill package. All subjects had a serum FSH:LH ratio > 1 and 20 of 21 (95%) subjects had E2 < 20 pg/mL (73 pmol/L) at the end of the pill-free interval of the third cycle. CONCLUSIONS: Measuring FSH on the 7th day of the pill-free interval is not a sensitive test for menopause. Serum FSH:LH ratio > 1 or E2 < 20 pg/mL (73 pmol/L) on the 7th day of the pill-free interval may be a more appropriate marker of menopause in women using OC in the later reproductive years.

Adult↗
PubMed2001

Constant estrogen, intermittent progestogen vs. continuous combined hormone replacement therapy: tolerability and effect on vasomotor symptoms.

OBJECTIVE: To compare the efficacy and tolerability of a novel oral constant estrogen plus intermittent progestogen hormone replacement therapy (HRT) regimen to a continuous combined HRT regimen in postmenopausal women. METHODS: Subjects were randomly assigned to receive treatment with either constant 17beta-estradiol (E2), 1 mg, plus intermittent norgestimate (NGM) 90 microg (3 days off, 3 days on) (n=221) or E2 2 mg/norethisterone acetate (NETA) 1 mg (n=217) for 1 year. Treatments were evaluated based on the incidence of hot flushes and uterine bleeding. RESULTS: Both regimens had similar bleeding profiles and provided comparable vasomotor symptom relief. However, breast discomfort and edema were experienced by twice as many subjects who received E2/NETA. CONCLUSIONS: The constant E2/intermittent NGM regimen was well tolerated and possesses similar efficacy compared with a continuous combined E2/NETA regimen and may be considered whenever HRT without withdrawal bleeding is deemed appropriate.

Adult↗