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

Sørdal, Terje; Grob, P; Verhoeven, Carole

doi:10.1111/j.1600-0412.2012.01498.x

Cited by 30 publications

(17 citation statements)

References 38 publications

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“…After 2 years, there were no differences between groups for bone outcomes. (46) In our study, we found significant associations of changes in serum estradiol levels over time with changes in HRpQCT measures of vBMD, bone geometry, and structure.…”

Section: Journal Of Bone and Mineral Researchsupporting

confidence: 57%

“…A study of premenopausal women who received a COC containing 17β‐E2 and nomegestrol acetate versus a COC containing ethinyl estradiol/levonorgestrel attempted to address this. After 2 years, there were no differences between groups for bone outcomes . In our study, we found significant associations of changes in serum estradiol levels over time with changes in HRpQCT measures of vBMD, bone geometry, and structure.…”

Section: Discussionmentioning

confidence: 41%

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Effects of Estrogen Replacement on Bone Geometry and Microarchitecture in Adolescent and Young Adult Oligoamenorrheic Athletes: A Randomized Trial

Ackerman

Singhal

Slattery

et al. 2019

Journal of Bone and Mineral Research

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Oligoamenorrheic athletes (OAs) have lower bone mineral density (BMD) and greater impairment of bone microarchitecture, and therefore higher fracture rates compared to eumenorrheic athletes. Although improvements in areal BMD (aBMD; measured by dual-energy X-ray absorptiometry) in OAs have been demonstrated with transdermal estrogen treatment, effects of such treatment on bone microarchitecture are unknown. Here we explore effects of transdermal versus oral estrogen versus no estrogen on bone microarchitecture in OA. Seventy-five OAs (ages 14 to 25 years) were randomized to (i) a 100-μg 17β-estradiol transdermal patch (PATCH) administered continuously with 200 mg cyclic oral micronized progesterone; (ii) a combined 30 μg ethinyl estradiol and 0.15 mg desogestrel pill (PILL); or (iii) no estrogen/progesterone (NONE) and were followed for 12 months. Calcium (≥1200 mg) and vitamin D (800 IU) supplements were provided to all. Bone microarchitecture was assessed using high-resolution peripheral quantitative CT at the distal tibia and radius at baseline and 1 year. At baseline, randomization groups did not differ by age, body mass index, percent body fat, duration of amenorrhea, vitamin D levels, BMD, or bone microarchitecture measurements. After 1 year of treatment, at the distal tibia there were significantly greater increases in total and trabecular volumetric BMD (vBMD), cortical area and thickness, and trabecular number in the PATCH versus PILL groups. Trabecular area decreased significantly in the PATCH group versus the PILL and NONE groups. Less robust differences between groups were seen at the distal radius, where percent change in cortical area and thickness was significantly greater in the PATCH versus PILL and NONE groups, and changes in cortical vBMD were significantly greater in the PATCH versus PILL groups. In conclusion, in young OAs, bone structural parameters show greater improvement after 1 year of treatment with transdermal 17β-estradiol versus ethinyl estradiol-containing pills, particularly at the tibia.

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Section: Journal Of Bone and Mineral Researchsupporting

confidence: 57%

Section: Discussionmentioning

confidence: 41%

Effects of Estrogen Replacement on Bone Geometry and Microarchitecture in Adolescent and Young Adult Oligoamenorrheic Athletes: A Randomized Trial

Ackerman

Singhal

Slattery

et al. 2019

Journal of Bone and Mineral Research

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“…The effects of NOMAC/E2 and LNG/EE (150 µg/30 µg) on bone mineral density (BMD) after 26 28-day treatment cycles were compared in an open-label prospective randomized study. 35 Seventy-five women of reproductive age (20–35 years) completed this 2-year study in Norway. Differences seen in BMD from baseline for lumbar spine and femoral neck between the treatment groups were not significant ( P =0.19 and P =0.57 respectively).…”

Section: Safetymentioning

confidence: 99%

Nomegestrol acetate/17-beta estradiol: a review of efficacy, safety, and patient acceptability

Akintomide¹,

Panicker²

2015

OAJC

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Nomegestrol acetate (NOMAC) 2.5 mg with 17-beta estradiol (E2) 1.5 mg is a new combined oral contraceptive (COC) formulation and is the first monophasic E2 pill to be marketed, having been licensed for use in Europe in 2011. It is available to be taken daily in a regimen of 24 active pills followed by four placebo pills. NOMAC is a highly selective 19-nor progestogen derivative with specific binding to progesterone receptors, anti-estrogenic activity and no androgenic, mineralocorticoid nor glucocorticoid effects. E2 is an estrogen that is identical to endogenous estrogen. While it has been in use for only a short period of time, current evidence suggests that NOMAC/E2 is just as effective, safe, and acceptable as existing COC preparations. Two large Phase III trials conducted in the Americas and across Europe, Australia, and Asia showed lower cumulative pregnancy rates in the NOMAC/E2 groups compared to the drospirenone (DRSP) 3 mg in combination with ethinyl estradiol (EE) 30 µg (DRSP/EE) groups but this difference was not statistically significant. NOMAC/E2 exhibits a good safety profile and has less effects on cardiovascular risk, hemostatic, metabolic, and endocrine factors in comparison to COCs containing EE in combination with levonorgestrel (LNG) or DRSP. NOMAC/E2 has also been found to cause less breast cell proliferation when compared to E2 alone and has some anti-proliferative effect on human breast cancer cells. NOMAC/E2 is considered acceptable as its compliance, continuation rates, and bleeding patterns were similar to COCs containing DRSP/EE and LNG 150 µg combined with EE 30 µg or LNG 100 µg combined with EE 20 µg (LNG/EE). However, discontinuation was found to be slightly higher in the NOMAC/E2 groups in the two large Phase III trials comparing NOMAC/E2 use with DRSP/EE. As the scientific literature has limited information on NOMAC/E2, further experience with NOMAC/E2 is required.

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“…However, the paper reported that while users of both regimens were found to have a drop in androgens and androgen precursors, users of EE/LNG were characterised by more pronounced decreases than users of E2/NOMAC, an interesting finding given the anti-androgenic character of NOMAC. In another comparative study of the E2/NOMAC regimen with an EE/LNG comparator (30 µg/150 µg), Sørdal and colleagues28 found no clinically relevant effect on bone mineral density among E2/NOMAC users and no significant difference in the bone mineral density of women using the two regimens after 26 cycles.…”

Section: E2/nomac Combination Oral Contraceptionmentioning

confidence: 99%

Changing convention in combination oral contraceptives: estradiol and nomegestrol acetate in a monophasic 24/4 regimen

Shulman

2013

J Fam Plann Reprod Health Care

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Initial oral contraceptive regimens were characterised by high doses of ethinylestradiol (EE) and a progestogen in a 21-day regimen that either included seven additional hormone-free tablets or simply the 21 days of combination hormonal tablets. These regimens were developed to ensure high contraceptive effectiveness, regular and predictable withdrawal bleeding episodes to mimic a menstrual cycle, and minimal unscheduled vaginal bleeding. However, these regimens were associated with adverse tolerability and safety issues resulting from the dose and characteristics of their hormonal components. Attempts to ameliorate these adverse issues included the development of lower-dose EE regimens, the incorporation of new progestogens, multiphasic regimens, and reduced hormone-free interval regimens. However, the EE component has remained a constant until the recent approval of combination oral contraceptives with an estrogen component other than EE. The development and introduction of an estradiol-based oral contraceptive regimen is presented in this review.

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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

Abstract: After two years, NOMAC/E2 had no clinically relevant effect on bone mineral density. No significant difference in the effect on bone mineral density between NOMAC/E2 and LNG/EE was observed.

Cited by 30 publications

References 38 publications

Effects of Estrogen Replacement on Bone Geometry and Microarchitecture in Adolescent and Young Adult Oligoamenorrheic Athletes: A Randomized Trial

Effects of Estrogen Replacement on Bone Geometry and Microarchitecture in Adolescent and Young Adult Oligoamenorrheic Athletes: A Randomized Trial

Nomegestrol acetate/17-beta estradiol: a review of efficacy, safety, and patient acceptability

Changing convention in combination oral contraceptives: estradiol and nomegestrol acetate in a monophasic 24/4 regimen

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