norethindrone / Generic mfg. - LARVOL DELTA

Relugolix Combination Tablets in Healthy Japanese Premenopausal Women: Pharmacokinetics, Pharmacodynamics, and Safety Profile. (PubMed, Reprod Med Biol) - "To evaluate the applicability of overseas-approved dosage of relugolix combination tablets (relugolix 40 mg, estradiol [E2] 1 mg, and norethisterone acetate 0.5 mg) in healthy premenopausal Japanese women. Relugolix combination tablets have favorable safety and efficacy profiles, potentially making them suitable for long-term use in Japanese patients. The trial registration number is JapicRCT2071230042."

Clinical • Journal • PK/PD data

Management of uterine leiomyoma and adenomyosis: role of hysteroscopy in diagnosis and norethindrone in the treatment. (PubMed, Sci Rep) - "Hysteroscopy has effective role in differentiating between adenomyosis and fibroids. Yet, long term follows up of abnormal uterine bleeding cases with large sample size in future research are still warranted."

Journal • Endometriosis • Gynecology • Infectious Disease • Pain • Solid Tumor • Uterine Cancer • Uterine Leiomyoma • Women's Health

The origins of oral contraception: The role of Mexican scientists in developing the first synthetic oral contraceptive progestin. (PubMed, Rev Invest Clin) - "In fact, norethindrone and its derivatives from Syntex were soon available worldwide, becoming the most widely used progestins in oral contraceptives. This review examines the interactions between scientific and social history, clarifying the roles of key figures and situating Mexico's contributions within a broader global context of reproductive autonomy."

Journal

Bone mineral density with elagolix plus add-back therapy in women with heavy menstrual bleeding and uterine fibroids: open-label and post-treatment results of a 60-month phase 3 trial. (PubMed, AJOG Glob Rep) - P3 | "Premenopausal women aged 18-50 years with HMB associated with uterine fibroids were randomized 2:1 to receive ELA+AB therapy (ELA 300 mg twice daily plus estradiol 1.0 mg/norethindrone acetate 0.5 mg once daily) or placebo during double-blind treatment. The long-term use of ELA+AB therapy was well tolerated, with no new safety signals identified. These findings support the potential of long-term ELA+AB therapy for HMB associated with uterine fibroids."

Clinical • Journal • P3 data • Gynecology • Infectious Disease • Musculoskeletal Diseases • Novel Coronavirus Disease • Orthopedics • Solid Tumor • Uterine Leiomyoma • Women's Health

Trends in the use of oral contraceptives and progestins in Japanese female Olympic athletes. (PubMed, Phys Sportsmed) - "A significant shift occurred from OCs containing ≥30 µg of ethinylestradiol (EE) to those containing 20 µg of EE, and from desogestrel-based OCs to those containing drospirenone and norethisterone. This trend highlights the growing importance of gynecological support in elite sports. Future research should focus on the potential performance and health effects of the newer-generation formulations that are now predominantly used."

Journal

Venous thromboembolism in obese hormonal contraceptive users: a large national database study. (PubMed, Res Pract Thromb Haemost) - "Obese users of levonorgestrel + ethinyl estradiol (EE) had a VTE rate of 0.55% vs 0.33% in nonobese users (P = .01, relative risk [RR] = 1.63)...No significant differences were found for progesterone-only HT users. In this large study comparing rates of VTE among obese and nonobese females on HT, a significantly higher risk of VTE was observed among obese females using certain HTs, particularly EE with levonorgestrel, norethindrone, and norgestimate. These results highlight the importance of considering obesity as a key risk factor when prescribing HT, particularly for females with higher body mass index."

Journal • Cardiovascular • Genetic Disorders • Obesity • Venous Thromboembolism

Gestational Gigantomastia: A Century of Evidence with a New Case. (PubMed, Plast Reconstr Surg Glob Open) - "First-line medical therapy (bromocriptine, cabergoline, or norethindrone) achieved partial arrest in approximately 35% of trials; definitive control required surgery in 57% (reduction mammaplasty 29%, mastectomy 28%). Early recognition, prompt endocrine modulation, and timely, staged surgery are critical. We provide the largest curated dataset to date, quantify the mortality risk, and propose a stepwise management algorithm to guide multidisciplinary teams confronting this formidable obstetric challenge."

Journal • Hematological Disorders • Infectious Disease • Obstetrics • Septic Shock

Risk of Venous Thromboembolic Events Among Obese Hormonal Contraceptive Users (ASH 2023) - "VTE rates among obese users versus non-obese users was significantly higher for most progesterone only options (p<0.001), excluding drospirenone only pills and high dose norethindrone (Table 1)... Of the 97,026,002 females who met inclusion criteria, 1,370,481 were obese and 2,649,987 were non-obese. The overall rate of VTE for obese vs. non-obese users was 0.9% vs."

Cardiovascular • Genetic Disorders • Obesity • Venous Thromboembolism

Preoperative relugolix combination therapy in laparoscopic myomectomy: a case series evaluating impact on surgical planes and operative outcomes. (PubMed, Arch Gynecol Obstet) - "This case series suggests that preoperative Relugolix-CT does not adversely affect surgical planes or operative outcomes. Although preliminary, these findings suggest benefits for surgical optimisation and support further investigation in larger, controlled studies."

Journal • Fibrosis • Gynecology • Immunology • Solid Tumor • Uterine Leiomyoma • Women's Health

Hepatocellular Adenoma Associated With Testosterone-Based Gender-Affirming Hormone Therapy in a Transgender Man (ACG 2025) - "We describe a case of hepatocellular adenoma in a transgender man likely linked to prolonged testosterone therapy.Case Description/ Case Presentation: A 19-year-old transgender man on transdermal testosterone and norethindrone for four years presented with chronic abdominal cramping. His medical history included dyslipidemia (treated with atorvastatin) and new persistent liver enzyme elevations over the preceding six months...Axial T1-weighted MRI of the liver (pre-contrast) showing multiple hypointense lesions: the largest in segment 8 (6 cm) and another in segment 4 (4 cm). These masses appear well-demarcated and hypointense compared to the surrounding liver parenchyma."

Biliary Cancer • Dyslipidemia • Hepatocellular Cancer • Hepatology • Infectious Disease • Metabolic Disorders

Not Your Typical Triglycerides: A Rare Case of Estrogen-Linked Pancreatitis (ACG 2025) - "She underwent a laparoscopic cholecystectomy and was discharged on a combination OCP (norethindrone acetate 1 mg, ethinyl estradiol 20 mcg)...Clinicians should maintain a high index of suspicion for medication-induced pancreatitis in young women presenting with compatible symptoms shortly after initiating OCP therapy. Prompt recognition and discontinuation of the causative agent are key to favorable outcomes."

Clinical • Cognitive Disorders • Dyslipidemia • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Hepatology • Hypertriglyceridemia • Pancreatitis • LPL

Evaluation of pharmacokinetic interactions between long-acting cabotegravir or emtricitabine/tenofovir disoproxil fumarate and hormonal contraceptive agents: a tertiary analysis of South African participants in HPTN 084. (PubMed, J Int AIDS Soc) - "Given the comparable hormone concentrations between arms and the likely influence of the timing of sample collection on observed measurements, clinically significant interactions between CAB-LA and HC are not expected. Associations between F/TDF and hormone concentrations could not be effectively evaluated due to low adherence to F/TDF."

Clinical • Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

Long-term extension study of Linzagolix for Uterine fibroids: Results after one year of treatment and 6 months post-treatment cessation (ESGE 2025) - "Participants were randomised to receive linzagolix 100 mg, linzagolix 100 mg with hormonal add-back therapy (ABT; 1 mg estradiol / 0.5 mg norethisterone acetate), linzagolix 200 mg, linzagolix 200 mg with ABT, or placebo. Conclusions One-year data from the PRIMROSE trials confirm the sustained efficacy of linzagolix in women with uterine fibroids. The rapid recurrence of symptoms following treatment cessation underscores the potential need for continued long-term therapy in women with uterine fibroids who benefit from oral GnRH antagonists."

Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

Free communication: Outcomes of linzagolix in women with concurrent Endometriosis and Adenomyosis: A post-hoc analysis of the EDELWEISS 3 and 6 trials (ESGE 2025) - "Subjects were randomized to linzagolix 200 mg with hormonal add-back therapy (ABT; 1 mg estradiol/0.5 mg norethisterone acetate), linzagolix 75 mg, or placebo for six months. Conclusions Linzagolix 200 mg+ABT, but not 75 mg, significantly improved DYS in women with concurrent endometriosis and adenomyosis. These findings support the potential benefit of higher-dose linzagolix for this patient population and warrant further investigation."

Clinical • Retrospective data • Endometriosis • Gynecology • Musculoskeletal Pain • Women's Health

Free communication: Linzagolix rapidly improves heavy menstrual bleeding and anaemia in women with uterine fibroids: A post-hoc analysis of the PRIMROSE 1 and 2 trials (ESGE 2025) - "Eligible women were randomised equally into five arms: linzagolix 100 mg or 200 mg, with or without add-back therapy (ABT; 1 mg oestradiol / 0.5 mg norethisterone acetate), or placebo. In anaemic women, linzagolix also led to greater and faster improvements in Hb and iron biomarkers than placebo. These findings support linzagolix as a novel medical treatment approach for symptomatic uterine fibroids, where a rapid and sustained control of HMB and concurrent improvement in anaemia is required."

Clinical • Retrospective data • Anemia • Gynecology • Hematological Disorders • Solid Tumor • Uterine Leiomyoma • Women's Health

Efficacy and Safety of Linzagolix in Black women with uterine fibroids: A post-hoc analysis of the PRIMROSE 1 and PRIMROSE 2 phase 3 trials (ESGE 2025) - "A total of 1,012 participants were randomized equally across five treatment arms: LGX 100 mg, LGX 100 mg with hormonal add-back therapy (ABT; 1 mg estradiol / 0.5 mg norethisterone acetate), LGX 200 mg, LGX 200 mg with ABT, and placebo. Mean bone mineral density (BMD) changes from baseline to Week 24 were: -1.73% (100 mg), -0.45% (100 mg + ABT), -3.68% (200 mg), and -0.33% (200 mg + ABT), indicating a protective effect of ABT on BMD loss. Conclusions LGX had a rapid and sustained effect on reducing clinically significant HMB (all doses) and FV (200mg LGX without ABT) in Black women vs placebo, demonstrating its effectiveness as a potential treatment option even for this higher-risk subset of UF patients."

Clinical • P3 data • Retrospective data • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

Norethindrone Acetate versus Combined Oral Contraceptives in Patients with Acute Abnormal Uterine Bleeding. (PubMed, J Pediatr Adolesc Gynecol) - "In our small sample, NA appeared to be as efficacious as COC. We found no difference in the time to bleeding cessation and length of hospital stay. Those treated with NA had fewer side effects than those treated with COC. We hope this pilot study will promote further inquiries as to whether NA may be the better choice for acute AUB in young women."

Journal • Gynecology • Women's Health

THORACIC ENDOMETRIOSIS: A CASE OF RECURRENT PNEUMOTHORAX DURING MENSES (CHEST 2025) - "She was referred to gynecology and treated with norethindrone acetate... Diagnosis of TES requires a high index of suspicion and should be considered in any biologic female with more than one episode of spontaneous PTX and history of dysmenorrhea."

Clinical • Endometriosis • Gynecology • Respiratory Diseases • Women's Health • ER • MME • PGR

Biotransformation of steroid hormones by intestinal fungi and their special cytotoxicity on HeLa cancer cells. (PubMed, Bioorg Chem) - "In addition, metabolites (1-29), including those derived from norethisterone biotransformation by Rhizopus microsporus PT2906 in a previous study (metabolites 23-29), displayed special cytotoxicity on cervical cancer HeLa cells...Additionally, the study results suggested that compound 26 may interact with the THR-256 and GLU-258 residues of p53 via hydrogen bonds. In conclusion, intestinal fungi play an important role in the metabolism of steroid hormones: they can biotransform nandrolone and testosterone into various derivatives, which can serve as crucial resources for cancer treatment."

Journal • Cervical Cancer • Oncology • Solid Tumor

Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

New P1 trial

PULMONARY THROMBOEMBOLISM AFTER CONCURRENT SELF-MEDICATED HORMONE THERAPY IN A HIV TRANSGENDER WOMAN (FIGO 2025) - "At the beginning of 2023, the patient also started taking, every ten days, a non-prescribed monthly injectable contraceptive containing estradiol valerate 5 mg and norethisterone enanthate 50 mg. In April 2023, the patient took a dose of injectable medroxyprogesterone... Self-medication is a sociocultural phenomenon that persists even when medical care is available. Expanding provision of medical follow-up, providing safer options for those at increased risk for thromboembolic events, addressing expectatives and satisfaction of the patients with their hormone therapy, health education and mental health care are measures that can reduce the exposure of this population to such risks."

Clinical • Cardiovascular • Hematological Disorders • Human Immunodeficiency Virus • Infectious Disease • Long-acting Reversible Contraceptives • Pulmonary Disease • Pulmonary Embolism

IMPLANET Clinical Trial: Norethisterone for prolonged bleeding in etonogestrel implant users (FIGO 2025) - P4 | "NETA (10 mg/day) effectively stops prolonged bleeding from ENG implants, marking the first randomized trial demonstrating progestin efficacy for this indication. Name of public trials registry in which the study has prospective registration: Treatment of Prolonged Uterine Bleeding of Etonogestrel (ENG)-Releasing Implant. URL of registration: https://clinicaltrials.gov/study/NCT04047875."

Clinical • Infectious Disease

Temporal Trends and Determinants of Low-Dose Estrogen-Progestin Prescription in Japan During 2014-2022: An Ecological Study Using a Nationwide Claims Database. (PubMed, J Obstet Gynaecol Res) - "This study provides the first comprehensive analysis of real-world LEP prescription patterns in Japan, revealing significant regional disparities."

Journal • Obstetrics • Women's Health

Safety and efficacy of relugolix combination therapy in symptomatic uterine fibroids. (PubMed, Facts Views Vis Obgyn) - "Relugolix-combination therapy (CT) (oestradiol 1 mg and norethindrone acetate 0.5 mg) is a new gonadotropin-releasing hormone antagonist licensed to treat heavy menstrual bleeding (HMB) associated with uterine fibroids; but little real-world data exists to guide practice. This real-world study supports previous controlled trial data showing relugolix-CT to be a safe, efficacious medical treatment for HMB with fibroids. Real-life clinical data support the use of relugolix-CT to treat symptomatic fibroids in isolation or combined with myomectomy."

Journal • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

An integrated drug delivery device for the localized treatment of the genitourinary syndrome of menopause. (PubMed, Int J Pharm) - "The platform comprises of a doughnut-shaped intravaginal device (DVDS) releasing estradiol hemihydrate (E2) and an intrauterine cylindrical unit (NLPM) delivering norethindrone acetate (NETA)...Moreover, cytocompatibility analyses showed an average cell viability exceeding the ISO 10993-5 minimum threshold of 70 % after 3 days, rising to above 80 % by Day 7 in both 2D and 3D models, thereby confirming the non-cytotoxic nature of the platform. In conclusion, the MUPP presents a promising and patient-friendly approach to addressing the current challenges of GSM therapy."

Journal • Long-acting Reversible Contraceptives • Women's Health