Nomegestrol acetate may enhance the skeletal effects of estradiol on biochemical markers of bone turnover in menopausal women after a 12-week treatment period

Nguyên-Pascal, M L; Thomas, Jean-Louis; Bergougnoux, L.; Garnero, Patrick; Drapier-Faure, E; Delmas, Pierre D.

doi:10.1080/13697130500103433

Cited by 5 publications

(4 citation statements)

References 10 publications

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“…The effect of NOMAC/E2 on BMD in women of fertile age has not been reported previously; however, in a 12‐week study, the effects of E2 (1.5 mg) alone, NOMAC/E2 (3.75 mg/1.5 mg) in combination and placebo on biochemical markers of bone turnover were investigated in postmenopausal women (35). 17β‐Estradiol (1.5 mg) was effective in reducing changes in total serum alkaline phosphatase, bone alkaline phosphatase, serum osteocalcin and urinary type‐1 collagen peptides associated with bone turnover compared with the placebo group.…”

Section: Discussionmentioning

confidence: 95%

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Effects on bone mineral density of a monophasic combined oral contraceptive containing nomegestrol acetate/17β‐estradiol in comparison to levonorgestrel/ethinylestradiol

Sørdal

Grob

Verhoeven

2012

Acta Obstet Gynecol Scand

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Section: Discussionmentioning

confidence: 95%

“…In addition, the combination of NOMAC/E2 maintained the beneficial effects of E2 alone on markers of bone remodeling. Although the study of Nguyen‐Pascal et al (35) was performed in postmenopausal women and used a higher dose of NOMAC, it also suggested that a combination of NOMAC and E2 had a neutral effect on BMD.…”

Section: Discussionmentioning

confidence: 99%

Effects on bone mineral density of a monophasic combined oral contraceptive containing nomegestrol acetate/17β‐estradiol in comparison to levonorgestrel/ethinylestradiol

Sørdal

Grob

Verhoeven

2012

Acta Obstet Gynecol Scand

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“…. Nomegestrol acetate at 5 mg/day combined with either 1.5 mg E 2 /day in a transdermal gel or 0.625 mg CEE/day in a short-term study of 6 months [46]; at 3.75 mg/day with 1.5 mg E 2 /day given for 3 months, the progestin induced slightly different changes in biochemical bone markers than the same dose of E 2 alone [47]. .…”

Section: Studies With Hormone Replacement Therapy In Postmenopausal Wmentioning

confidence: 99%

Long-term effects of progestins on bone quality and fractures

Thijssen

2007

Gynecological Endocrinology

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The effects of progestins on the quality of bone and their influence on the risk of fractures are reviewed. Data discussed are based on experimental studies in vivo that generally lasted for longer than one year. Information is given on the background of osteoporosis and on several means of inducing changes in bone quality. In young women who start using oral contraceptives based on progestins alone shortly after pubertal development, a significant decrease in bone quality has been documented. World Health Organization experts have concluded that this is not a real argument for restrictions on the use of these contraceptives. In postmenopausal women, no evidence has been found for a bone-protective or an estrogen-antagonistic effect of progestins. A wide range of estrogens have been used that have shown positive effects on bone, which are not antagonized by progestins. The therapeutic use of high-dose megestrol acetate may result in marked negative effects on bone, leading to severe osteoporosis, possibly due to the inherent glucocorticoid activity of this progestin. Other pharmacotherapeutic agents that can be used in postmenopausal therapy, and that clearly have beneficial effects on bone, are discussed.

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“…There is no reason to suspect that fracture risk is elevated among users of any oral contraceptive formulation. A randomized trial of 176 postmenopausal women suggested that the combination of NOMAC 3.75 mg + E2 1.5 mg, given daily for 12 weeks, had “no deleterious effects” on bone health, and seemed to decrease markers of bone turnover 36. Currently available data reassure us that NOMAC-E2 oral contraception does not adversely affect bone mineral density.…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

Nomegestrol acetate-17b-estradiol for oral contraception

Burke¹

2013

PPA

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Oral contraceptives remain a popular method of contraception over 50 years after their introduction. While safe and effective for many women, the failure rate of oral contraception is about 8%. Concerns about the risk of venous thromboembolism continue to drive the search for the safest oral contraceptive formulations. The oral contraceptive NOMAC-E2 contains nomegestrol acetate (NOMAC) 2.5 mg + 17b-estradiol (E2) 1.5 mg. The approved dosing regimen is 24 days of active hormone, followed by a 4-day hormone-free interval. NOMAC is a progestin derived from testosterone, which has high bioavailability, rapid absorption, and a long half-life. Estradiol, though it has a lower bioavailability, has been successfully combined with NOMAC in a monophasic oral contraceptive. Two recently published randomized controlled trials demonstrate that NOMAC-E2 is an effective contraceptive, with a Pearl Index less than one pregnancy per 100 woman-years. The bleeding pattern on NOMAC-E2 is characterized by fewer bleeding/spotting days, shorter withdrawal bleeds, and a higher incidence of amenorrhea than the comparator oral contraceptive containing drospirenone and ethinyl estradiol. The adverse event profile appears to be acceptable. Few severe adverse events were reported in the randomized controlled trials. The most common adverse events were irregular bleeding, acne, and weight gain. Preliminary studies suggest that NOMAC-E2 does not seem to have negative effects on hemostatic and metabolic parameters. While no one oral contraceptive formulation is likely to be the optimum choice for all women, NOMAC-E2 is a formulation with effectiveness comparable with that of other oral contraceptives, and a reassuring safety profile.

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Nomegestrol acetate may enhance the skeletal effects of estradiol on biochemical markers of bone turnover in menopausal women after a 12-week treatment period

Abstract: These results demonstrated that 1.5 mg E(2) is effective in reducing bone turnover in postmenopausal women and proved that the combination of 1.5 mg E(2) and 3.75 mg nomegestrol acetate has no deleterious effect on bone remodelling.

Cited by 5 publications

References 10 publications

Effects on bone mineral density of a monophasic combined oral contraceptive containing nomegestrol acetate/17β‐estradiol in comparison to levonorgestrel/ethinylestradiol

Effects on bone mineral density of a monophasic combined oral contraceptive containing nomegestrol acetate/17β‐estradiol in comparison to levonorgestrel/ethinylestradiol

Long-term effects of progestins on bone quality and fractures

Nomegestrol acetate-17b-estradiol for oral contraception

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