Estelle (estetrol/drospirenone) / Mithra, Mayne Pharma, Fuji Pharma, M3 inc - LARVOL DELTA

Venous Thromboembolism with Combined Oral Contraceptives Based on Estrogen and Progestin Content: A disproportionality analysis of the United States Food and Drug Administration Adverse Event Reporting System database. (PubMed, Am J Obstet Gynecol) - "Combined oral contraceptives containing body-identical estrogens, estetrol, and 17β-estradiol, have lower proportions of venous thromboembolism reports than EE-based pills and are similar to progestin-only pills. These findings suggest a potentially safer thrombotic profile of body-identical estrogen-based combined oral contraceptives."

Adverse events • Journal • Cardiovascular • Venous Thromboembolism

Science stories for young readersAlberto Salas Plays Paka Paka con la Papa, Sara Andrea Fajardo and Juana Martinez-Neal (illustrator), Roaring Brook Press, 2025, 40 pp.; for ages 4 to 8.Marjory's River of Grass: Marjory Stoneman Douglas, Fierce Protector of the Everglades, Josie James, Christy Ottaviano Books, 2025, 40 pp.; for ages 4 to 8.The Little Lobster: A Lobster Tale, W. Thomas Hotz and (PubMed, Science) - No abstract available

Journal

Multicenter trial evaluating the safety and tolerability of estetrol-drospirenone combined oral contraceptive in postmenarchal female adolescents (ISGE 2026) - P3 | "The use of E4/DRSP in adolescents was well tolerated, resulted in a predictable bleeding pattern, and relief of dysmenorrhea."

Clinical • Women's Health

Health-related quality of life outcomes among women using estetrol/drospirenone for contraception: findings from the CARE4HER real-world observational study (ISGE 2026) - "HRQoL was stable in E4/DRSP users over the course of the study for all domains with significant improvements observed in total SEC-QoL scores as well as psychological and sexual domains."

Clinical • HEOR • Observational data • Real-world • Real-world evidence • Long-acting Reversible Contraceptives

The Effect of E4/DRSP on Menstrual Symptoms and Health-related Quality of Life in Adolescents (ISGE 2026) - P3 | "Estetrol/drospirenone (E4/DRSP) is a COC with good safety and tolerability profile in adults and adolescents and demonstrated positive effect on pre-menstrual and menstrual symptom relief in adults... E4/DRSP reduced symptom burden key in menstrual symptoms and improved HRQoL in adolescents. Its native estrogen and progesterone-like progestin profile may support acceptability and adherence in this population."

Clinical • HEOR • Back Pain

Effects of hormonal contraception on mood symptoms – A randomized, double-blind, longitudinal study (ISGE 2026) - "Participants randomized to ethinylestradiol-levonorgestrel experienced significantly greater worsening in irritability, lability and core mood symptoms compared to participants randomized to estetrol-drospirenone, who showed no significant mood changes. Marked individual variability highlights the importance of personalized contraceptive counseling."

Clinical • Longitudinal study • Observational data • CNS Disorders • Depression • Mood Disorders

Impact of estetrol and drospirenone combination therapy on alleviation of the pelvic pain of endometriosis: a randomized control trial. (PubMed, F S Rep) - "The E4/DRSP combination therapy has the potential to improve the quality of life of patients with endometriosis, with greater amelioration of nonmenstrual EAPP than EE/DRSP. JPRN-jRCT2080225090."

Journal • Endometriosis • Gynecology • Musculoskeletal Pain • Pain • Women's Health

Delivering virtual cardiac rehabilitation within correctional facilities to fulfill the decree of Estelle versus Gamble. (PubMed, NPJ Digit Med) - No abstract available

Journal

Post Hoc Analysis of a Previous Study of Estetrol 15 mg/Drospirenone 3 mg Combination for Dysmenorrhea and Uterine Bleeding in Adenomyosis Patients. (PubMed, Reprod Med Biol) - "Estetrol/drospirenone ameliorates adenomyosis-associated symptoms, offering safer treatment with potentially reduced thromboembolic risk. jRCT registration number: jRCT2011210023."

Clinical • Journal • Retrospective data • Cardiovascular • Endometriosis • Venous Thromboembolism • Women's Health

Multicentre Trial Evaluating the Safety and Tolerability of Estetrol-Drospirenone Combined Oral Contraceptive in Postmenarchal Female Adolescents. (PubMed, J Clin Med) - "Pain medication use decreased from 63.9% to 31.6% in Cycle 6. The use of E4/DRSP in adolescents raised no safety concerns, was well tolerated, resulted in a clear and stable cyclic bleeding pattern, and reduced pain associated with dysmenorrhea."

Journal • Pain • Women's Health

Delayed start of estetrol drospirenone versus ethinyl estradiol gestodene for ovulation inhibition in a noninferiority randomized controlled trial. (PubMed, Sci Rep) - P=N/A | "Cervical mucus profiles and adverse events, including unscheduled bleeding, did not differ significantly between the groups. Initiating E4/DRSP on cycle day 7-9 appears comparable to that of EE/GS for ovulation inhibition; however, high ovulation rates limit the confirmation of non-inferiority.Clinical trial registration: ClinicalTrials.gov Registration on April 25, 2024 (ID: NCT06396221; https://clinicaltrials.gov/study/NCT06396221 )."

Head-to-Head • Journal

Fifty Years of Care and Carcerality. (PubMed, J Clin Ethics) - "In particular, we focus on how the carceral context may impact medical decision-making and how clinical ethicists (and providers) should respond. Nearly 50 years after Estelle v. Gamble established the right to healthcare in prisons and jails, we observe that providers continue to struggle with many of the ethical challenges Dubler identified decades ago."

Journal • Human Immunodeficiency Virus • Infectious Disease

Effects of estetrol/drospirenone versus ethinyl estradiol/drospirenone on glucose tolerance in women with polycystic ovary syndrome: A randomised controlled trial. (PubMed, Diabetes Obes Metab) - "E4/DRSP was not inferior to EE/DRSP in its effects on glucose tolerance, insulin levels and HOMA-IR, supporting its use as a potential oral contraceptive option in women with PCOS."

Journal • Polycystic Ovary Syndrome

HOLTER CO-PRE: Prospective Evaluation on the Role Exerted by Hormonal Contraceptives on 24-h Blood Pressure. A Prospective Observational Study (clinicaltrials.gov) - P=N/A | N=96 | Recruiting | Sponsor: Ospedale Policlinico San Martino

New trial • Cardiovascular

Suturing under tension in minimally invasive surgery: A comparison of three intracorporeal knot types : Philipp Romero1, Hans Kessler1, Juri Fuchs1, Estelle Willuth1, Frank Pianka2, Patrick Günther1. (PubMed, Langenbecks Arch Surg) - "The MSK showed similarly good results to the SLK. Both the MSK and SLK appear particularly well-suited for tension sutures."

Clinical • Journal

Oral Drospirenone/Estetrol as Rapid and Random Start Endometrial Preparation before Office Hysteroscopic Polypectomy: a Multicenter, Prospective, Randomized Controlled Trial. (PubMed, Gynecol Obstet Invest) - "Limitations Limited sample size; possible variability due to different hysteroscopists, caused by the multicenter nature of the study; hysteroscopists were unmasked to treatment allocation; absence of a cost-effectiveness analysis. Conclusions Treatment with drospirenone/estetrol could provide rapid, satisfactory and low-cost endometrial preparation before office polypectomy, improving surgical performance and patient compliance."

Journal • Pain

ERASE: Estetrol/Drospirenone to Reduce the Average Size of Endometriomas (clinicaltrials.gov) - P4 | N=21 | Recruiting | Sponsor: Andrew Zakhari | Active, not recruiting ➔ Recruiting

Enrollment open • Endometriosis

Is LAAC Feasible in Patients Who Cannot Tolerate Any Anticoagulation? - Estelle Torbey (ACC 2025) - No abstract available

Clinical

Effects of estetrol/drospirenone on Self-Reported Physical and Emotional Premenstrual and Menstrual Symptoms: Data from the Phase 3 Clinical Trial in the United States and Canada. (PubMed, Contraception) - "Estetrol/drospirenone starters experienced the most significant improvements in the MDQ domains Pain, Water Retention, and Negative Affect. Domain scores for switchers remained stable."

Journal • P3 data • Back Pain • Fatigue • Mood Disorders • Pain • Psychiatry

Estetrol/Drospirenone Safety in a Population with Cardiovascular Risk Factors. (PubMed, Contraception) - "Among >1400 study participants with cardiovascular risk factors using estetrol/drospirenone, only three (0.2%) discontinued for hypertension, all of whom had high-normal baseline BP and at least one other risk cardiovascular risk factor."

Journal • Cardiovascular • Hematological Disorders • Hypertension • Thrombosis

ERASE: Estetrol/Drospirenone to Reduce the Average Size of Endometriomas (clinicaltrials.gov) - P4 | N=21 | Active, not recruiting | Sponsor: Andrew Zakhari | Recruiting ➔ Active, not recruiting

Enrollment closed • Endometriosis

Cosette Pharmaceuticals Announces Acquisition of Mayne Pharma, Transforming Company into a Leader in Women’s Health and Dermatology (Businesswire) - "Cosette Pharmaceuticals...announced today that it has entered into a definitive agreement to acquire all the outstanding shares of Mayne Pharma Group Limited (ASX: Ticker MYX) (Mayne Pharma) at AUD$7.40/share for a total consideration of approximately USD $430 Million. The Boards of Directors of both companies have approved the transaction and Mayne Pharma’s Board of Directors has unanimously recommended that its shareholders vote in favor of the transaction. The transaction is expected to close in the second quarter of 2025....Upon close, Cosette will market 12 patent-protected products focused on women’s health and dermatology, including leading brands such as VYLEESI, INTRAROSA, NEXTSTELLIS, ANNOVERA, BIJUVA, IMVEXXY and RHOFADE, and several programs in clinical development."

M&A • Dermatology • Women's Health

Respective Contribution of Ictal and Interictal Electrical Source Imaging to Epileptogenic Zone (AES 2024) - "Funding: Estelle Rikir was supported by a grant from the Medical Council of the CHU of Liège, Belgium... This prospective study with a strictly uniform methodology does not show a better overall sensitivity and specificity of ictal compared to inter-ictal ESI but demonstrates the relevance of (i) a distinct inter-ictal and ictal analyses and (ii) a combined interpretation of both electrical source localizations. Inter-ictal analysis gave the highest sensitivity whereas ictal analysis gave the highest specificity. Inter-ictal ESI would be particularly interesting in MRI negative (supposed FCD) patients while ictal analy- sis would be considered primarily in (i) MCD patients and/ or with an MRI lesion, and, (ii) initial spike or rhythmic discharge > 13 Hz as ictal EEG pattern."

CNS Disorders • Epilepsy

ERASE: Estetrol/Drospirenone to Reduce the Average Size of Endometriomas (clinicaltrials.gov) - P4 | N=21 | Recruiting | Sponsor: Andrew Zakhari | Not yet recruiting ➔ Recruiting

Enrollment open • Endometriosis

Association Between Perinatal Factors and Childhood Lymphoma-A Pooled Analysis of the ESCALE and ESTELLE Studies (SFCE). (PubMed, Pediatr Blood Cancer) - "Maternal coffee and alcohol consumptions during pregnancy and paternal smoking during preconception/pregnancy might increase the risk of childhood NHL. While warranting replication, these findings could help us better understand the aetiology of childhood lymphoma."

Journal • Retrospective data • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology