MICRONIZED 17β-Estradiol FOR ORAL ESTROGEN THERAPY IN MENOPAUSAL WOMEN

Callantine, Merritt R.; Martin, Purvis L.; Bolding, O. Thomas; Warner, Phillip O.; Greaney, M. O.

doi:10.1097/00006254-197511000-00020

Cited by 5 publications

(7 citation statements)

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“…Estrogen use was reported as early as 1935 to relieve vaginal symptoms 61 . These symptoms have been shown to respond to both vaginal 62 and systemic ERT, 63 , 64 although with systemic treatment, benefit may not be seen for up to 12 to 18 months following initiation of therapy 65 . Vaginal estrogens have been shown to be well absorbed systemically, 66 , 67 although in very low doses (0.3 mg of conjugated estrogens or less), absorption may be reduced 68 .…”

Section: Therapeutic and Preventive Uses Of Hrt/ertmentioning

confidence: 99%

Perimenopausal hormone replacement therapy Review of the literature

Lichtman¹

1991

Journal of Nurse-Midwifery

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Section: Therapeutic and Preventive Uses Of Hrt/ertmentioning

confidence: 99%

Perimenopausal hormone replacement therapy Review of the literature

Lichtman¹

1991

Journal of Nurse-Midwifery

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“…This innovative HRT regimen, which consists of a continuous administration of 17b-estradiol (E 2 ) 1 mg alone for 3 days, followed by E 2 1 mg plus norgestimate (NGM) 90 mg for 3 days, takes advantage of estrogen and progesterone receptor dynamics, thereby producing the desired effects on the endometrium with lower doses of both hormones (18). E 2 is the most commonly used estrogen in HRT (19), while NGM, which possesses minimal androgenic activity (20,21), has been used primarily in oral contraceptives.…”

mentioning

confidence: 99%

Intermittent progestin administration as part of hormone replacement therapy: long-term comparison between estradiol 1 mg combined with intermittent norgestimate and estradiol2 mg combined with constant norethisterone acetate

Ylikorkala¹,

Wahlström²,

Caubel³

et al. 2002

Acta Obstet Gynecol Scand

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Background. To decrease exposure to progestin during hormone replacement therapy (HRT), a novel oral regimen consisting of constant 17b-estradiol (E 2 ) daily plus intermittent norgestimate (NGM) has been developed. Methods. A multicenter study compared the safety and efficacy of E 2 1 mg daily plus intermittent NGM 90 mg (3 days off, 3 days on) (n Ω 150) vs. a continuous oral dose of E 2 2 mg plus norethisterone acetate (NETA) 1 mg (n Ω 172) daily, for a period of 2 years. Endometrial biopsies were performed at 1 and 2 years. Subjects recorded the occurrence of vasomotor symptoms, uterine bleeding, and adverse events on diary cards. Results. At 2 years' follow-up, no subject had developed endometrial hyperplasia or cancer. Endometrial atrophy was seen in 75% of subjects using the intermittent NGM regimen and in 78% of women using the constant NETA regimen. Both groups maintained a 96% reduction in vasomotor symptoms up to 2 years. The rates of bleeding and/or spotting showed no difference between the groups, and at 2 years' follow-up, 73% of women in the intermittent NGM group and 83% of subjects in the constant NETA group were amenorrheic. There was a lower incidence of progestin-associated side-effects, such as abdominal discomfort, edema, painful bleeding episodes, and breast symptoms, with the intermittent progestin regimen vs. the constant progestin regimen. Intermittent NGM use was associated with an elevation in HDL-and HDL 2 -cholesterol, whereas constant NETA reduced these lipoproteins. Conclusions. The intermittent administration of a progestin, such as NGM, provides a new, well-tolerated regimen to achieve endometrial safety, an adequate rate of amenorrhea, and effective reduction of vasomotor symptoms in postmenopausal women.

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“…O ral estrogen replacement therapy (ERT) has been shown to be effective in the treatment of vasomotor symptoms 1,2 and in the prevention of osteoporosis in postmenopausal women. [3][4][5] Additional evidence suggests that ERT may also protect against cardiovascular disease in this population.…”

mentioning

confidence: 99%

Lack of Effect of a High‐Fat Meal on the Bioavailability of 17β‐Estradiol/Norgestimate in Healthy Postmenopausal Women

Gisclon¹,

Curtin²,

Larson³

et al. 2000

The Journal of Clinical Pharma

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The effect of a high-fat meal on the absorption and pharmacokinetics of 17 beta-estradiol (E2), estrone (E1), estrone sulfate (E1S), and 17-deacetylnorgestimate (17d-NGM) were determined in this two-way complete crossover study of a single dose of E2/NGM (2 mg/180 micrograms) in 24 postmenopausal women. Equal numbers of subjects were randomly assigned to two treatment sequences indicated by the order of fed and fasting treatments. Serial blood samples were collected before and after dosing and assayed using validated methods. Food had no effect on the pharmacokinetics of E2, the pharmacologically active estrogen species. Food increased the rates of formation of E1 and E1S and slowed the formation of 17d-NGM. However, because E1 and E1S are pharmacologically less active metabolites of E2, and since the pharmacokinetic alterations in 17d-NGM were observed over a short time period, these results are probably of no clinical relevance. The extent of formation of all analytes, as measured by AUC, was not affected by food. In conclusion, administration of a tablet containing 17 beta-estradiol/norgestimate (2 mg/180 micrograms) was safe and well tolerated by healthy postmenopausal women and may be given without regard to the timing of meals in relation to dosing.

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MICRONIZED 17β-Estradiol FOR ORAL ESTROGEN THERAPY IN MENOPAUSAL WOMEN

Cited by 5 publications

References 0 publications

Perimenopausal hormone replacement therapy Review of the literature

Perimenopausal hormone replacement therapy Review of the literature

Intermittent progestin administration as part of hormone replacement therapy: long-term comparison between estradiol 1 mg combined with intermittent norgestimate and estradiol2 mg combined with constant norethisterone acetate

Lack of Effect of a High‐Fat Meal on the Bioavailability of 17β‐Estradiol/Norgestimate in Healthy Postmenopausal Women

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