estradiol / Teva - LARVOL DELTA

Differentiating Depressive Symptoms From Side Effects in Individuals With Major Depressive Disorder With Postpartum Onset. (PubMed, J Clin Psychopharmacol) - "These findings underscore the importance of reviewing somatic symptoms before administering medication to discern true treatment emergent side effects, especially in populations recovering from labor and delivery. Somatic symptoms decline in parallel with depressive symptom scores during treatment, suggesting they are indicative of underlying illness rather than side effects."

Adverse events • Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Pain • Psychiatry

Comparison of Combined Oral Contraceptives and a Transdermal Estrogen Patch With Oral Progesterone: Treatment of Abnormal Uterine Bleeding in Adolescents. (PubMed, Cureus) - "Methods Thirty patients who were treated with either 30 μg ethinyl estradiol/3 mg drospirenone combined oral contraceptive (group A) or 1.95 mg 17β-estradiol transdermal patch and 5 mg oral medroxyprogesterone acetate combined treatment (group B) for six months in the pediatric endocrinology department between years 2017 and 2019 were enrolled in our study retrospectively, and a questionnaire was performed on them to assess their treatment satisfaction. Menstrual irregularity stopped after two months of treatment in both groups, but one (6.6%) and three (20.0%) patients reported that AUB repeated within three months of treatment cessation in group A and group B, respectively. Conclusion Immaturity of the hypothalamo-pituitary-ovarian axis in adolescence can present with a wide range of symptoms and proves challenging to choose the proper treatment regimen."

Journal • Endocrine Disorders • Pain • Pediatrics • Women's Health

Use of an estradiol transdermal spray in women with menopausal symptoms: a non-interventional study. (PubMed, Climacteric) - "Most common ADRs were headache (n = 6), nausea (n = 4), dizziness (n = 4) and pruritus (n = 3). EMDTS is an effective, well tolerated and easily applied hormone replacement therapy for women experiencing postmenopausal symptoms."

Journal • Observational data • Dermatology • Pain • Pruritus

Breast cancer cases diagnosed during hormone replacement therapy (JBCS 2024) - "The drugs used for hormone replacement therapy were estradiol, norethisterone acetate (Menoaid) in two cases, estradiol (Jurina) + dydrogesterone (Duphaston) in two cases, eltradiol gel in one case, and estradiol transdermal preparation + dydrogesterone (Duphaston) in one case. [Discussion] Patients undergoing hormone replacement therapy, which affects the development of breast cancer, should be encouraged to undergo regular breast cancer screening by their gynecologist, and it is important to work with breast medical institutions to promptly encourage patients to undergo breast cancer screening when they have symptoms related to the breast. Summary: We report a case of breast cancer undergoing hormone replacement therapy"

Clinical • Breast Cancer • Gynecology • Oncology • Pain • Solid Tumor

HORMONE REPLACEMENT THERAPY IN A PATIENT WITH ANDROGEN INSENSITIVITY AND FACTOR V LEIDEN (ASPHO 2024) - "In discussion with patient and family, taking into account negative family history of thrombosis and patient quality of life concerns, decision was made to proceed with low dose (12.5 mcg) estradiol transdermal patch without prophylactic anticoagulation... HRT is necessary after gonadectomy to prevent symptoms of hypoestrogenism and maintain secondary sexual features in CAIS. In patients with heterozygous FVL mutations requiring HRT, compounding VTE risk is of concern. Most data regarding management comes from older populations (i.e."

Clinical • Cardiovascular • Hematological Disorders • Osteoporosis • Rheumatology • Venous Thromboembolism

Formulation and characterization of nanoparticle-based ethinyl estradiol transdermal drug delivery system for contraception and menopausal disorders. (PubMed, Pak J Pharm Sci) - "The product was found stable. The developed patches of EE nanoparticles were expected to improve patient compliance by reducing dose frequency and provide optimum therapy by sustained drug release for contraception."

Journal

Assessing tolerability and physiological responses to 17α-estradiol administration in male rhesus macaques. (PubMed, Geroscience) - "We also surmise that the elevated level of unconjugated 17α-estradiol was subjected to a greater degree of isomerization to 17β-estradiol, which is aligned with the sevenfold increase in serum 17β-estradiol in 17α-estradiol treated animals in our first trial. Future studies in monkeys, and certainly humans, would likely benefit from the development and implementation of 17α-estradiol transdermal patches, which are commonly prescribed in humans and would circumvent potential issues with bolus dosing effects."

Journal • Obesity

Extended regimen of a levonorgestrel/ethinyl estradiol transdermal delivery system: Predicted serum hormone levels using a population pharmacokinetic model. (PubMed, PLoS One) - P1 | "These results indicate that a 12-week extended LNG/EE regimen would provide similar systemic hormonal exposure as that seen by week 3 in a standard 28-day regimen, without further hormonal accumulation. The data support the safe use of a non-daily, low-dose hormonal contraceptive in an extended regimen but should be confirmed in a clinical PK study."

Clinical • Journal • PK/PD data

When GI Endoscopy Shines a Light on the Endometrium (ACG 2022) - "Interestingly, it was noted that she was using an estradiol transdermal patch on initial consultation. This is significant since endometrial tissue is estrogen-sensitive and may have promoted this presentation."

Colon Cancer • Colorectal Cancer • Endometriosis • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Gynecology • Immunology • Inflammation • Musculoskeletal Pain • Oncology • Pain • Solid Tumor • Women's Health • ER • MME • PAX8

[VIRTUAL] THE ROLE OF NEUROKININ B IN THE PATHOPHYSIOLOGICAL MECHANISMS OF VASOMOTOR SYMPTOMS AND SLEEP DISORDERS IN POSTMENOPAUSAL WOMEN. (EMAS 2021) - "Group I received MHT 17-β estradiol transdermal gel 0.75 mg daily and micronized progesterone 100 mg daily vaginally. Patients of the I and II groups were comparable in age, postmenopause duration and anthropometric indicators. NKB levels in Groups I and II were significantly higher compared to the control group (P1 <0.001, P2= 0.003). NKB levels in Group I were 2.3 times higher than in Group II (P3 <0.001)."

Clinical • CNS Disorders • Sleep Disorder

[VIRTUAL] Achieving Physiologic 17-ẞ-Estradiol Levels in Transgender Females on Estradiol Transdermal Patches and Optimal Dosing (ENDO 2021) - "We looked at the success of achieving physiologic serum 17-β-estradiol levels (with and without antiandrogens spironolactone and finasteride) on various doses of estradiol transdermal patches. For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021."

CNS Disorders

Changes in Marrow Adipose Tissue in Relation to Changes in Bone Parameters Following Estradiol Replacement in Adolescent and Young Adult Females with Functional Hypothalamic Amenorrhea. (PubMed, Bone) - "We show that in adolescent and young adult girls with FHA, MAT decreases following transdermal estrogen therapy and these changes are associated with increased cortical vBMD."

Clinical • Journal • Women's Health

Efficacy, Safety, and Tolerability of a Levonorgestrel/Ethinyl Estradiol Transdermal Delivery System: Phase 3 Clinical Trial Results. (PubMed, Contraception) - "The low-dose LNG/EE TDS was effective in preventing pregnancy in a population of women representative of US demographics. Efficacy was reduced in women with BMI ≥30 kg/m. The TDS safety and tolerability profile was consistent with other similar dose combined hormonal contraceptives. Results of this phase 3 study supported the FDA approval of TWIRLA® for prevention of pregnancy in women with BMI <30 kg/m."

Clinical • Journal • P3 data • Cardiovascular • Pain

Venous thromboembolism in the hormonal milieu. (PubMed, Curr Opin Hematol) - "Hormonal therapy affects VTE risk to varying degrees dependent on specific type of hormone, formulation, and occasionally route of delivery."

Journal • Cardiovascular • Long-acting Reversible Contraceptives • Venous Thromboembolism

[VIRTUAL] A Case of Pituitary Hyperplasia Secondary to Uncontrolled Primary Hypothyroidism (ENDO-I 2020) - "Her menstrual cycles were regular but this was only after she was placed on norelgestromin/ ethinyl estradiol transdermal patch. Pituitary MRI showed pituitary hyperplasia that has decreased compared to previous MRI, now measuring around 1 cm at the largest dimension without contact with the optic chiasm and the Infundibulum was at midline. Galactorrhea and headaches resolved and fatigue significantly improved."

Clinical • Constipation • Endocrine Disorders • Fatigue • Oncology • Papillary Thyroid Cancer • Solid Tumor • Thyroid Cancer • IGF1 • MRI

Appraising cervical mucus: a new approach to evaluating contraceptives. (PubMed, Eur J Contracept Reprod Health Care) - P4; "Our artificial cycle model (leuprolide acetate suppression) and dose escalation with estradiol patches produced favourable cervical mucus with mucus scores similar to those in the periovulatory phase of natural menstrual cycles. Additional studies are needed to validate the model for evaluation of mucus effects of contraceptive agents."

Journal • Biosimilar • Long-acting Reversible Contraceptives

A Case of Pituitary Hyperplasia Secondary to Uncontrolled Primary Hypothyroidism (ENDO 2020) - "Her menstrual cycles were regular but this was only after she was placed on norelgestromin/ ethinyl estradiol transdermal patch. Pituitary MRI showed pituitary hyperplasia that has decreased compared to previous MRI, now measuring around 1 cm at the largest dimension without contact with the optic chiasm and the Infundibulum was at midline. Galactorrhea and headaches resolved and fatigue significantly improved."

Clinical • IGF1 • MRI

Impact of Route of Estrogen Administration on Bone Turnover Markers in Oligoamenorrheic Athletes and its Mediators. (PubMed, J Clin Endocrinol Metab) - "Seventy-three participants with OA between 14 and 25 years old received (i) a 17β-estradiol transdermal patch continuously with cyclic oral micronized progesterone (PATCH), (ii) a combined ethinyl estradiol and desogestrel pill (PILL), or (iii) no estrogen/progesterone (NONE) for 12 months. Transdermal 17β-estradiol given over 12 months does not cause the decrease in IGF-1 observed with oral ethinyl estradiol. It also leads to decreases in sclerostin, Pref-1 and BDNF, which may mediate the beneficial effects of estrogen."

Journal

Comparison of a transdermal contraceptive patch with a newly sourced adhesive component versus EVRA patch: A double-blind, randomized, bioequivalence and adhesion study in healthy women. (PubMed, Contraception) - "The test patch with the newly sourced adhesive component is bioequivalent to the currently marketed NGMN-EE transdermal patch and has similar adhesion and irritation potential."

Clinical • Journal

Does the route of administration for estrogen hormone therapy impact the risk of venous thromboembolism? Estradiol transdermal system versus oral estrogen-only hormone therapy. (PubMed, Menopause) - "This large population-based study suggests that participants receiving an estradiol transdermal system have a significantly lower incidence of venous thromboembolism than do participants receiving oral estrogen-only hormone therapy."

Journal

Effects of Estrogen Replacement on Bone Geometry and Microarchitecture in Adolescent and Young Adult Oligo-amenorrheic Athletes- a Randomized Trial. (PubMed, J Bone Miner Res) - "Seventy-five OA (ages 14-25 years) were randomized to (i) a 100 mcg 17β-estradiol transdermal patch (PATCH) administered continuously with 200 mg cyclic oral micronized progesterone, (ii) a combined 30 mcg ethinyl estradiol and 0.15 mg desogestrel pill (PILL), or (iii) no estrogen/progesterone (NONE) and were followed for 12 months. 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 vs. PILL and NONE groups, and changes in cortical vBMD were significantly greater in the PATCH vs. PILL groups. In conclusion, in young oligo-amenorrheic athletes, bone structural parameters show greater improvement after one year of treatment with transdermal 17?-estradiol vs. ethinyl estradiol containing pills, particularly at the tibia."

Clinical • Journal

Oestrogen replacement improves bone mineral density in oligo-amenorrhoeic athletes: a randomised clinical trial. (PubMed, Br J Sports Med) - P3; "Transdermal estradiol over 12 months improves BMD in young OAA, particularly compared with an ethinyl estradiol-containing contraceptive pill/oral contraceptives."

Clinical • Journal

Impact of Route of Estrogen Administration on Bone Turnover Markers in Oligoamenorrheic Athletes and Mediators of these Effects (ENDO 2019) - "Further, it is unclear how the route of estrogen administration impacts bioavailable testosterone, which in turn may impact bone outcomes in young oligo-amenorrheic women.73 OA 14-25 years old received (i) a 17β-estradiol transdermal patch continuously with cyclic oral micronized progesterone (PATCH), (ii) a combined ethinyl estradiol and desogestrel pill (PILL), or (iii) no estrogen/progesterone (NONE) for 12-months. Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*"

Low Systemic Levels of Segesterone Acetate are Required to Inhibit Ovulation in Women (ENDO 2019) - "SA specifically binds to progesterone receptors; it does not bind to sex hormone-binding globulin (SHBG) and has no estrogenic or androgenic activity.The effects of SA on ovulation inhibition were first examined in dose-finding studies of subdermal implants, which showed that the mechanism of ovulation inhibition was concentration dependent.1,2 Another study of subdermal implants releasing 45-50 mcg SA/day, showed ovulation did not occur with SA plasma levels >105 pmol/L; women who ovulated had SA levels ranging from 68 to <105 pmol/L.3 The effects of SA on ovulation inhibition were also evaluated in vaginal rings delivering 3 different doses (50, 75, 100 mcg/day) of SA for 6 months.4 These doses effectively inhibited ovulation, with SA serum levels remaining fairly constant through the study at ~125, 200 and 250 pmol/L, respectively, decreasing slightly over time.4 A study using a SA/estradiol transdermal gel demonstrated full suppression of ovulation and follicle..."

Clinical

A Rare Diagnosis in a Female Adolescent Presenting with Primary Amenorrhea (ENDO 2019) - "The patient was started on weekly 0.050 mg Estradiol transdermal patch with gradual titration and will be followed with cyclical estrogen-progesterone replacement therapy. Early institution of hormonal therapy is essential to induce puberty and prevent osteoporosis. If not evaluated for early, patients who present with normal female phenotypes, despite non-functional gonads, will not present until adolescence with a chief complaint of primary amenorrhea."