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

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

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

Impact of Estetrol Combined with Drospirenone on Blood Coagulation and Fibrinolysis in Patients with Endometriosis: A Multicenter, Randomized, Open-Label, Active-Controlled, Parallel-Group Study. (PubMed, Clin Appl Thromb Hemost) - "Eventually, the fibrinolysis cascade was triggered to compensate for disturbed coagulation, and D-dimer levels were 4.7-fold higher in the EE/DRSP group than in the E4/DRSP group. This study demonstrated that the effect of E4/DRSP on the blood coagulation and fibrinolysis cascades was significantly less than that of EE/DRSP in participants with endometriosis, a disease of women of advanced and reproductive age (jRCT2080225090, https://jrct.niph.go.jp/en-latest-detail/jRCT2080225090)."

Clinical • Journal • Cardiovascular • Endometriosis • Gynecology • Venous Thromboembolism • Women's Health • PROS1

Estetrol/drospirenone oral contraceptive impact on lipid parameters in 40-50 year olds (NAMS 2024) - "Changes in total cholesterol, LDL, HDL and triglyceride levels from baseline to end of treatment in a phase 3 contraceptive trial of estetrol/drospirenone were minimal and did not differ between participants 40-50 years and 16-39 years. These results support that estetrol/drospirenone has a negligible impact on lipid parameters in primarily healthy older users."

Dyslipidemia • ER

Bleeding patterns with use of an oral contraceptive containing estetrol and drospirenone in older participants from two phase-3 clinical trials (NAMS 2024) - "We found no overall differences in scheduled and unscheduled bleeding/spotting or bleeding-related TEAEs across 12 cycles of estetrol/drospirenone use in participants 40-50 years compared to 16-39 years. These results demonstrate positive bleeding outcomes with estetrol/ drospirenone use in older combined oral contraceptive users."

Clinical • P3 data • Gynecology • Hematological Disorders

ERASE: Estetrol/Drospirenone to Reduce the Average Size of Endometriomas (clinicaltrials.gov) - P4 | N=21 | Not yet recruiting | Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre | Trial primary completion date: Jul 2026 ➔ Oct 2026

Trial primary completion date • Endometriosis

ERASE: Estetrol/Drospirenone to Reduce the Average Size of Endometriomas (clinicaltrials.gov) - P4 | N=21 | Not yet recruiting | Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre | Trial completion date: Aug 2026 ➔ Dec 2026 | Trial primary completion date: Feb 2026 ➔ Jul 2026

Trial completion date • Trial primary completion date • Endometriosis

Evaluating the toxicity of estetrol, 17α-ethinylestradiol, and their combination with drospirenone on zebrafish larvae: A behavioural and proteomic study. (PubMed, Aquat Toxicol) - "These findings suggest that E4-based combined oral contraceptives present a more favourable environmental profile than EE2-based contraceptives, particularly during the early developmental stages of fish."

Journal

Safety and tolerability of the Estetrol/Drospirenone contraceptive pill in starters compared to switchers (ESCRH 2024) - P3 | "The total incidence of adverse events in E4/DRSP starters and true new starters is notably lower than that observed in switchers, additionally AEs dysmenorrhea, viral upper respiratory tract infections and acne were reported more frequently in switchers. These findings reinforce the favourable safety profile of E4/DRSP in the starter group. Conflict details: KGD is ad hoc advisory board member and speaker for Organon (MSD), Bayer, Exelgyn, Actavis, Gedeon Richter, Mithra, Exeltis, Ferring, Natural Cycles, Azanta, Gynuity, Obseva MedinCell, Cirqle, Addeira and HRA-Pharma, member of the ICCR, Population council and Director of a WHO collaborating centre for research in Human Reproduction and investigator of ongoing NICHD male contraception trial."

Clinical • Acne Vulgaris • CNS Disorders • Depression • Infectious Disease • Nephrology • Pain • Psychiatry • Respiratory Diseases • Women's Health

Safety and tolerability of the Estetrol/Drospirenone contraceptive pill in young women up to 25 years of age (ESCRH 2024) - P3 | "There is no significant difference in incidence of AEs experienced in E4/DRSP users between the two different age groups in the phase 3 clinical trials, except for AEs dysmenorrhea and urinary tract infection which occur more frequently in the 16-25 years age group. These results further underscore the favourable safety profile of E4/DRSP in young COC users."

Clinical • Acne Vulgaris • Infectious Disease • Nephrology • Pain • Respiratory Diseases • Women's Health

Estetrol/drospirenone versus 17α-ethinylestradiol/drospirenone: An extended one generation test to evaluate the endocrine disruption potential on zebrafish (Danio rerio). (PubMed, Environ Int) - "In contrast, E4/DRSP induced only minor histopathological changes and an increase in the proportion of males, at the highest concentration tested (∼30× PEC) in the F1 generation and had no effect on hatching success of F2 generation. Overall, this study suggests that the combination E4/DRSP has a more favourable environmental profile than EE2/DRSP."

Journal

Differential impact of desogestrel, drospirenone or the combination estetrol/drospirenone on global coagulation (ISGE 2024) - "These results indicate that DSG does not impact global coagulation, whereas DRSP induces a slight increase of the coagulation among users. This increase was similar to the one observed in E4/DRSP users. This study highlights the importance of selecting the appropriate POC based on the progestin compound involved, as they do not have a similar impact on the patient's coagulation profile."

Clinical • Cardiovascular

Dynamic Patterns of Psychoemotional and Cognitive Indicators in Reproductive Age Women Receiving a Monophasic Combined Estetrol-Drospirenone -Containing Oral Conraceptive (ISGE 2024) - "Conclusion. The currently available data on the neuroprotective effect of estetrol on the central nervous system require further study and analysis."

Clinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Mood Disorders • Psychiatry

The use of drospirenone/estetrol in random start rapid preparation of endometrium before office hysteroscopic polypectomies: a multicenter, prospective, randomized study (ISGE 2024) - "We enrolled 103 patients. No significant differences were found between the two groups in terms of age, parity, BMI, pre-HP-PBAC and endometrial thickness at diagnosis. On the day of HP, the D/E group showed significant differences in terms of pre- and post-HP endometrial thickness (p<0.001)."

Clinical • Gynecology • Women's Health

The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation (clinicaltrials.gov) - P4 | N=120 | Completed | Sponsor: University of Palermo

New P4 trial • Women's Health

The Use of Drospirenone/Estetrol in Random Start Rapid Endometrial Preparation (clinicaltrials.gov) - P4 | N=103 | Completed | Sponsor: University of Palermo

New P4 trial • Women's Health