Risk of venous thromboembolism associated with local and systemic use of hormone therapy in peri- and postmenopausal women and in relation to type and route of administration

Bergendal, Annica; Kieler, Helle; Sundström, Anders; Hirschberg, Angelica Lindén; Kocoska-Maras, Ljiljana

doi:10.1097/gme.0000000000000611

Cited by 71 publications

(40 citation statements)

References 33 publications

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“…Local vaginal therapies are considered to have lower adverse event profiles than other commonly used systemic estrogen therapies, 4 such as decreased risk of endometrial stimulation, breast tenderness, hemostatic changes, and venous thromboembolism. 4,19–21 Overall, no unexpected adverse events were observed with the low-dose softgel estradiol capsule, TX-004HR. 5 …”

Section: Discussionmentioning

confidence: 93%

Consistency of Effect with a Low-Dose, Estradiol Vaginal Capsule (TX-004HR): Evaluating Improvement in Vaginal Physiology and Moderate-to-Severe Dyspareunia in Subgroups of Postmenopausal Women

Constantine¹,

Bouchard

Pickar

et al. 2017

Journal of Women's Health

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Background: The 12-week, randomized, double-blind, placebo-controlled, multicenter, phase 3 REJOICE trial demonstrated that TX-004HR, an investigational, applicator-free, low-dose vaginal softgel capsule containing solubilized 17β-estradiol, effectively and rapidly treats symptoms of vulvar and vaginal atrophy (VVA) with negligible to very low systemic absorption. The aim of this analysis was to assess whether the efficacy of TX-004HR varies with age, body mass index (BMI), uterine status, pregnancy status, and vaginal delivery.Methods: The REJOICE trial evaluated the efficacy of 4-, 10-, and 25-μg doses of TX-004HR in postmenopausal women (40–75 years) with VVA and a self-identified most bothersome symptom of moderate-to-severe dyspareunia. Prespecified subgroup analyses of the four co-primary endpoints (percentages of superficial cells and parabasal cells, vaginal pH, and severity of dyspareunia) were analyzed with respect to age, BMI, uterine status, pregnancy status, and vaginal births. Each dose was compared with placebo for change from baseline to week 2 through week 12, respectively.Results: TX-004HR significantly improved superficial cells, parabasal cells, and vaginal pH from baseline to weeks 2 and 12 in most subgroups. All TX-004HR doses numerically reduced the severity of dyspareunia by 2 weeks and maintained efficacy over 12 weeks, with many of the subgroups having statistically significant improvement relative to placebo.Conclusions: TX-004HR was efficacious for treating symptomatic VVA, and it demonstrated a consistency of effect when women's age, BMI, uterine status, pregnancy status, and vaginal births were evaluated. Clinical Trial Identifier: NCT02253173.

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Section: Discussionmentioning

confidence: 93%

Consistency of Effect with a Low-Dose, Estradiol Vaginal Capsule (TX-004HR): Evaluating Improvement in Vaginal Physiology and Moderate-to-Severe Dyspareunia in Subgroups of Postmenopausal Women

Constantine¹,

Bouchard

Pickar

et al. 2017

Journal of Women's Health

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“…Estrogen transdermal formulations may be preferred over other formulations due to lower rates of venous thromboembolism (VTE) and stroke. 115 Micronized progestin may be preferred over medroxyprogesterone acetate (MPA) due to lower rates of VTE and breast cancer risk. Other hormonal options for treating hot flashes include novel therapies that combine a selective estrogen receptor modulator (SERM) with estrogen, creating a tissue selective estrogen complex, one of which contains a conjugated estrogen and the SERM bazedoxifene 116 and is FDA-approved for treating menopausal symptoms in healthy postmenopausal women.…”

Section: Menopausementioning

confidence: 99%

Survivorship, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology

Denlinger¹,

Sanft²,

Baker³

et al. 2017

J Natl Compr Canc Netw

102

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Many cancer survivors experience menopausal symptoms, including female survivors taking aromatase inhibitors or with a history of oophorectomy or chemotherapy, and male survivors who received or are receiving androgen-ablative therapies. Sexual dysfunction is also common in cancer survivors. Sexual dysfunction and menopause-related symptoms can increase distress and have a significant negative impact on quality of life. This portion of the NCCN Guidelines for Survivorship provide recommendations for screening, evaluation, and treatment of sexual dysfunction and menopausal symptoms to help healthcare professionals who work with survivors of adult-onset cancer in the posttreatment period.

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“…On deciding to treat a hypogonadal TM woman with estrogen and progestin, consideration must be given to the general condition of the patient, current chelation therapy and the presence of associated complications 34–36…”

Section: Conclusion and Recommendationsmentioning

confidence: 99%

“…Micronized progesterone is composed of smaller particles that may aid in absorption. It was proposed as first-line progestin because there are reasons to believe that natural progesterone might be safer for the cardiovascular system (no adverse lipid effects) and possibly the breast, although the strongest evidence for endometrial protection is for oral cyclical combined treatment 34,35,37–39…”

Section: Conclusion and Recommendationsmentioning

confidence: 99%

Review and Recommendations on Management of Adult Female Thalassemia Patieνts With Hypogonadism Based on Literature Review and Experience of Icet-a Network Specialists

Sanctis¹,

Soliman

Elsedfy

et al. 2017

Mediterr J Hematol Infect Dis

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BackgroundMulti-transfused thalassemia major (TM) patients frequently develop severe endocrine complications, mainly due to iron overload, anemia, and chronic liver disease, which require prompt diagnosis, treatment and follow-up by specialists.The most common endocrine complication documented is hypogonadotropic hypogonadism which increases with age and associated comorbidities. It is thus important for physicians to have a clear understanding of the pathophysiology and management of this disorder. Also to be aware of the side effects, contraindications and monitoring of sex steroid therapy. In this paper, practical ICET-A recommendations for the management of hypogonadism in adult females with TM are addressed.MethodsIn March 2015, the Coordinator of the International Network of Clinicians for Endocrinopathies in Thalassemia and Adolescent Medicine (ICET-A) conducted a two-step survey to assess the attitudes and practices of doctors in the ICET-A network taking care of adult female TM patients with hypogonadism. They were clinically characterized by the absence of pubertal development or discontinuation or regression of the maturation of secondary sex characteristics, and biochemically by persistent low FSH, LH and estradiol levels. Recently a supplementary survey on adult female hypogonadism in TM was undertaken within the ICET-A network.ResultsThe completed questionnaires were returned by 16 of 27 specialists (59.2%) following 590 female TM patients over the age of 18 years; 315 patients (53.3%) had hypogonadism, and only 245 (74.6%) were on hormone replacement therapy (HRT). Contraceptive oral pills (COC) were the first treatment choice in 11 centers (68.7%). A wide range of COCs was used with different progestin contents. In general, the patients’ compliance to treatment was reported as good in 81.2 % of centers. The frequency of required tests for follow-up HRT, in addition to the regular check-up for thalassemia, was variable in the participating centers.ConclusionsDoctors taking care of TM patients should have sound knowledge of the pathophysiology of hypogonadism in adult females with TM. They should know the potential effects of HRT including advantages and disadvantages of estrogen and progestins. Moreover, they should keep in consideration the emotional needs of these patients dreaming of attaining a full pubertal development.

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Risk of venous thromboembolism associated with local and systemic use of hormone therapy in peri- and postmenopausal women and in relation to type and route of administration

Cited by 71 publications

References 33 publications

Consistency of Effect with a Low-Dose, Estradiol Vaginal Capsule (TX-004HR): Evaluating Improvement in Vaginal Physiology and Moderate-to-Severe Dyspareunia in Subgroups of Postmenopausal Women

Consistency of Effect with a Low-Dose, Estradiol Vaginal Capsule (TX-004HR): Evaluating Improvement in Vaginal Physiology and Moderate-to-Severe Dyspareunia in Subgroups of Postmenopausal Women

Survivorship, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology

Review and Recommendations on Management of Adult Female Thalassemia Patieνts With Hypogonadism Based on Literature Review and Experience of Icet-a Network Specialists

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