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

Efficacy of estetrol/drospirenone in premenstrual syndrome/premenstrual dysphoric disorder (clinicaltrials.gov) - P=N/A | N=60 | Active, not recruiting | Sponsor: Fukushima Medical University | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Depression • Gynecology

Fifty Years After Estelle v. Gamble - Where Does Carceral Health Law Go from Here? (PubMed, J Law Med Ethics) - "Given these constraints, we argue for a carceral health law paradigm that moves beyond the current, dominant focus on litigation. We use Medicaid law and policy as a case study to explore the potential and drawbacks of a broader administrative structure for carceral health care."

Journal

Effects of estetrol/drospirenone vs drospirenone-only on thrombin generation in women with polycystic ovary syndrome: a randomized, double-blind, controlled trial. (PubMed, Res Pract Thromb Haemost) - "E4/DRSP and DRSP-only had comparable effects on thrombin generation and TM-mediated anticoagulation in women with PCOS. E4/DRSP reduced hirsutism, supporting its consideration as a treatment option for PCOS."

Clinical • Journal • Acne Vulgaris • Cardiovascular • Polyendocrine Metabolic Ovarian Syndrome • Venous Thromboembolism

Estetrol/drospirenone for combined oral contraception: a systematic review of efficacy, cycle control, and safety. (PubMed, Front Endocrinol (Lausanne)) - "E4/DRSP is an effective combined oral contraceptive with favorable cycle control and a consistent biologic profile suggesting lower hepatic/hemostatic impact than ethinyl estradiol-containing formulations. However, current evidence does not establish comparative thromboembolic safety, which requires dedicated postauthorization and real-world comparative studies."

Clinical • Journal • Review • Cardiovascular • Endometriosis • Gynecology • Women's Health

Hemostatic safety profile of estetrol vs. ethinylestradiol in oral contraceptives: a systematic review and meta-analysis. (PubMed, Rev Bras Ginecol Obstet) - "To evaluate the hemostatic profile of estetrol/drospirenone (E4/DRSP) compared with ethinylestradiol/drospirenone (EE/DRSP) in adult women. E4/DRSP demonstrates a more favorable hemostatic profile than EE/DRSP, potentially reducing thrombotic risk. Despite the limited number of RCTs, consistency across markers supports E4 as a safer estrogenic component for contraceptive formulations, with implications for women at increased risk of venous thromboembolism.PROSPERO registry: #CRD420251074961."

Clinical • Journal • Retrospective data • Review • Cardiovascular • Venous Thromboembolism • PROS1

Cerebral Venous Sinus Thrombosis Occurring During Estetrol/Drospirenone Combined Oral Contraceptive Use in a Woman With Multiple Thrombotic Risk Factors: A Case Report. (PubMed, J Obstet Gynaecol Res) - "She was treated with anticoagulation and transitioned to relugolix for adenomyosis management. Although E4/DRSP has a favorable coagulation profile, thrombotic risk persists in women with adenomyosis and severe anemia. Pre-prescription assessment including correction of anemia and consideration of estrogen-free alternatives is warranted."

Journal • Cardiovascular • Endometriosis • Genetic Disorders • Gynecology • Hematological Disorders • Hypertension • Obesity • Thrombocytosis • Thrombosis • Women's Health

Withdrawal of semaglutide results in weight regain, increased alcohol intake and metabolic disorders in a diet-induced obese hamster model of MetALD (ECO 2026) - "Withdrawal from semaglutide results in rapid weight regain, increased intake of high-fat diet and fructose/alcohol in the drinking water, dyslipidemia and worsening liver fibrosis. This preclinical hamster model could be used to evaluate novel therapies that would prevent metabolic disorders following semaglutide withdrawal. Conflicts of Interest & Funding: François Briand, Estelle Grasset, Claire Bigot, Natalia Breyner and Thierry Sulpice are employees of Physiogenex."

Preclinical • Addiction (Opioid and Alcohol) • Cardiovascular • Congestive Heart Failure • Dyslipidemia • Fibrosis • Heart Failure • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Thermal Abandonment: Best Practices to End Correctional Heat Death for Menopausal Black Women in Prison. (PubMed, J Correct Health Care) - "Under the Estelle v. Gamble (1976) deliberate indifference standard, these patterns constitute cruel and unusual punishment...Thermal abandonment is deliberate indifference. It is also reversible."

Journal • Cardiovascular

Continuous estetrol/drospirenone regimen for the treatment of endometriosis-related pain: preliminary results. (PubMed, Gynecol Endocrinol) - "E4/DRSP demonstrated efficacy and tolerability for managing endometriosis-related pain, offering a promising option for long-term treatment. Further research is needed to confirm its impact on lesion regression and disease progression."

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

Arterial Vascular Effects of Estetrol-drospirenone Combined Oral Contraceptive Pill (clinicaltrials.gov) - P3 | N=98 | Not yet recruiting | Sponsor: Dr. Hang Wun Raymond Li

New P3 trial

Estetrol-based combined oral contraceptives: A systematic review of clinical outcomes. (PubMed, Acta Obstet Gynecol Scand) - "E4-containing COCs could potentially be a safer and more effective alternative to contraceptive use. The findings should be interpreted with caution, as study limitations such as design and confounder bias, small study populations, and short follow-up times characterize the studies included in this review. Further, industry sponsorship bias cannot be ruled out. Further independent research is needed to confirm long-term safety and applicability of E4-containing COCs across diverse populations."

Clinical data • Journal • Review • Cardiovascular • Novel Coronavirus Disease • Venous Thromboembolism

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