progesterone / Generic mfg. - LARVOL DELTA

Oral dydrogesterone versus oral micronized progesterone: Interim analysis of a randomized controlled trial in pregnant women with threatened miscarriage. (PubMed, Int J Reprod Biomed) - "No AE was related to study medication. Compared to oral MP, oral DYD resulted in a numerically lower miscarriage rate and time to symptom resolution, concomitant to favorable decrease in Th1:Th2 ratio."

Journal • Oncology • Pain • IFNG • IL10 • IL4 • TNFA

Progesterone in feminizing gender affirming hormone therapy: study protocol for a randomized placebo-controlled trial. (PubMed, Contemp Clin Trials Commun) - P2 | "This randomized, double-blind, placebo-controlled clinical trial will evaluate oral micronized progesterone 200 mg nightly versus matched placebo in transgender women aged 18-60 years who have been receiving stable feminizing hormone therapy for at least 6 months. Registered in www.clinicaltrials.gov on January 29, 2025 with registration number NCT06807580. FDA IND #171225."

Clinical • Journal • CNS Disorders • Sleep Disorder

Expanding the Horizons of Menopausal Hormone Therapy: A Narrative Review of Progestogen-Only and Testosterone-Only Strategies for Tailored Management. (PubMed, J Menopausal Med) - "Evidence suggests that progestogen-only therapy, particularly oral micronized progesterone (oP4), offers a robust alternative for alleviating vasomotor symptoms and sleep disturbances through its action on GABAergic neurosteroid pathways. Notably, observational data from large cohort studies, including the Etude Epidémiologique auprès de femmes de la Mutuelle Générale de l'Education Nationale study, suggest that oP4 and dydrogesterone are associated with a more favorable risk profile for venous thromboembolism and breast cancer than synthetic progestins used in combined hormone therapy...In the absence of approved female-specific testosterone products in South Korea, cautious off-label dosing and rigorous monitoring remain essential. Overall, monotherapy with progestogens or testosterone constitutes a vital component of tailored menopause management, if clinicians adhere to evidence-based protocols and remain aware of the current limitations in..."

Journal • Review • Breast Cancer • Cardiovascular • CNS Disorders • Oncology • Sexual Disorders • Sleep Disorder • Solid Tumor • Venous Thromboembolism

The WinPro trial: A window of opportunity study of endocrine therapy with and without prometrium in postmenopausal women with early stage hormone receptor-positive breast cancer. (ASCO 2025) - P2 | "Patients (pts) were randomised 1:1:1 to letrozole (let) 2.5mg daily, letrozole 2.5mg daily + prometrium (pro) 300mg daily, or tamoxifen (tam) 20mg daily + prometrium 300mg daily for 11-17 days before surgery... The WinPro trial showed that the addition of pro to let in post-menopausal women with ER+, PR+, HER2- breast cancer was safe, reduced hot flushes and led to similar reduction in Ki67 as let alone. Ongoing translational analyses are underway which will examine the changes in gene expression in malignant, immune and stromal cells at sub-cellular resolution and provide further insight into the mechanisms of response and resistance to endocrine therapy."

Clinical • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • AR • ER • HER-2 • PGR

Drug-associated psoriasis: a pharmacovigilance study based on the FAERS database. (PubMed, Front Pharmacol) - "These signals involved several pharmacological categories, including anti-infective agents (e.g., Abacavir, Fluconazole, Moxifloxacin, Sulfamethoxazole), anti-inflammatory and immunomodulatory drugs (e.g., Celecoxib, Tofacitinib), cardiovascular agents (e.g., Acebutolol, Telmisartan, Clonidine), neuropsychiatric drugs (e.g., Nortriptyline, Temazepam, Zopiclone, Wellbutrin), hormonal agents (e.g., Progesterone, Prometrium), and respiratory medications (e.g., Ventolin). Our findings suggest that multiple drug classes are associated with psoriasis signals in pharmacovigilance data. These results highlight the importance of early recognition of drug-associated psoriasis and may assist clinicians in medication review and risk stratification in routine practice."

Adverse events • Journal • Cardiovascular • Dermatology • Immunology • Psoriasis • Psychiatry

MP4 MPS: Progesterone and Muscle Protein Synthesis in Premenopausal Women (MP4-MPS) (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: McMaster University | Not yet recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ May 2026 | Initiation date: Sep 2025 ➔ Jan 2026 | Trial primary completion date: Dec 2025 ➔ May 2026

Trial completion • Trial completion date • Trial initiation date • Trial primary completion date

Menopausal Hormone Therapy: A Narrative Review of Contemporary Evidence. (PubMed, Pharmacotherapy) - "Contemporary data support the preferential use of transdermal estradiol due to its lower risk of venous thromboembolism and favor oral micronized progesterone (MP) over synthetic progestogens when endometrial protection is required. Continued research is needed to refine dosing targets, evaluate long-term preventive outcomes, and expand evidence for modern formulations beyond WHI-era therapies. Ultimately, MHT should be viewed not as a one-size-fits-all therapy, but as a personalized, evidence-informed strategy that supports the health and quality of life of menopausal women."

Journal • Review • Cardiovascular • Oncology • Venous Thromboembolism • Women's Health

Isolated β-Human Chorionic Gonadotropin Elevation-From Pregnancy to Fragile X-associated Premature Ovarian Insufficiency. (PubMed, AACE Endocrinol Diabetes) - "After removal of the IUD and methotrexate therapy for presumed ectopic pregnancy in an unknown location, β-HCG level remained elevated...Hormone therapy with oral estradiol 2 mg daily and cyclic oral micronized progesterone 200 mg on 12 days of each month was initiated...After pregnancy has been ruled out, less common causes of β-HCG elevations like gestational trophoblastic disease, germ cell tumors, POI associated menopause, and heterophile antibody interference, should be evaluated. FXPOI should be considered in young patients with β-HCG elevation."

Journal • Endocrine Disorders • Germ Cell Tumors • Gestational Trophoblastic Neoplasia • Long-acting Reversible Contraceptives • Oncology • Women's Health • FMR1

PROSPECT: A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix (clinicaltrials.gov) - P3 | N=1311 | Completed | Sponsor: The George Washington University Biostatistics Center | N=437 ➔ 1311

Enrollment change

Pharmacokinetics of subcutaneous hormonal bioabsorbable implants of estradiol and testosterone in postmenopausal women (ISGE 2026) - "For endometrial protection, oral micronized progesterone 100 mg for 14 days at month 3...Conclusions — In symptomatic postmenopausal women, the E2 25 mg plus T 50 mg sc bioabsorbable implants regimen seems to be the best combination choice, providing physiologic hormone levels, without adverse events. Studies with larger sample sizes are needed to validate these preliminary results."

Clinical • PK/PD data • CNS Disorders • Depression • Mood Disorders

Thromboelastometry (ROTEM) Assessing Coagulability in Postmenopausal Women Using Subcutaneous Bioabsorbable Estradiol and Testosterone Implants (ISGE 2026) - "Women with a uterus received oral micronized progesterone 100 mg/day for 14 days in month 3. Sc bioabsorbable E and T implants did not alter thromboelastometry or conventional hemostatic markers over six months, providing no laboratory evidence of hypercoagulability. Larger, randomized and longer-duration trials - including thrombin generation assays - are warranted to confirm long-term thrombotic safety."

Clinical • Cardiovascular • Venous Thromboembolism

No more sleepless nights in perimenopause-an open-label, randomized, parallel-group, active controlled intervention study in perimenopausal women with vasomotor symptoms and insomnia to investigate the efficacy of hormone replacement therapy and cognitive behavioral therapy for the treatment of insomnia: study protocol. (PubMed, Trials) - P4 | "The goal is to enable evidence-based treatment decisions for affected women to close the menopausal medical care gap and improve women's quality of life. TRIAL REGISTRATION {2A, 2B}: The study has been registered at ClinicalTrials.gov (Identifier: NCT06497894) on 11 July 2024. URL: (https://clinicaltrials.gov/ct2/show/NCT06497894). PROTOCOL VERSION AND TRIAL STATUS {3}: Protocol version 3.1 (30. April 2024). Recruitment has not started yet (15. August 2024). The recruitment is planned to begin on 01. November 2024, with an estimated completion date of 01. April 2026."

Journal • CNS Disorders • Insomnia • Sleep Disorder

CLEAR-3: Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach (clinicaltrials.gov) - P4 | N=124 | Completed | Sponsor: University of Illinois at Chicago | N=90 ➔ 124

Enrollment change • Psychiatry • Suicidal Ideation

Estrogen Supplementation and Bone Health in Women With CF (clinicaltrials.gov) - P4 | N=75 | Recruiting | Sponsor: Johns Hopkins University | Trial completion date: Dec 2025 ➔ Jan 2027 | Trial primary completion date: Dec 2025 ➔ Jan 2027

Trial completion date • Trial primary completion date • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Obesity results in lower integrin expression in women with polycystic ovarian syndrome during the window of implantation. (PubMed, Front Endocrinol (Lausanne)) - P=N/A | "An endometrial tissue sample was collected after 10 days of daily oral micronized progesterone (Utrogestan 200 mg) in the PCOS group. Further research is needed to confirm these results and to identify the potential mechanisms underlying this association. ClinicalTrial.gov, identifier NCT04175002."

Journal • Endocrine Disorders • Genetic Disorders • Obesity • Polycystic Ovary Syndrome • CDH1 • MUC1

MP4 MPS: Progesterone and Muscle Protein Synthesis in Premenopausal Women (MP4-MPS) (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: McMaster University

New P1 trial

Estrogen Variability and Irritability During the Menopause Transition (clinicaltrials.gov) - P4 | N=40 | Completed | Sponsor: University of North Carolina, Chapel Hill | Recruiting ➔ Completed

Trial completion

PROSPECT: A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix (clinicaltrials.gov) - P3 | N=437 | Completed | Sponsor: The George Washington University Biostatistics Center | Active, not recruiting ➔ Completed | Trial completion date: Jun 2025 ➔ Feb 2025

Trial completion • Trial completion date

Preferences and Barriers to Hormone Replacement Therapy in the Transgender Population-Single Center Experience (ENDO 2025) - "One MTF was on additional oral micronized progesterone and she reported that her mood swings and breast development improved dramatically after the use of progesterone...From this small retrospective chart review, we conclude that for FTM, all our patients preferred the injections and the twice-weekly dosing. All the MTF patients were on pills. Most of these patients tried patches or gels and reported unwanted side effects or lack of desired masculinizing or feminizing effects with topical preparations."

Clinical • Cardiovascular • CNS Disorders • Dyslipidemia • Genetic Disorders • Hypertension • Metabolic Disorders • Obesity

Feasibility of Cyclic Progesterone and Spironolactone for PCOS-specific Health-Related Quality of Life—a six-month, Phase II, single arm, single center, open-label study (ENDO 2025) - "We hypothesized cyclic oral micronized progesterone (CyclicP4) and spironolactone (Sp) would improve HRQoL, decrease LH, and acne...Exclusion criteria included HbA1c > 6.4%, use of metformin or CHC in the last month...Though the small sample size limited generalizability, findings are promising. A larger randomized trial comparing CyclicP4 vs. CHC is warranted."

Clinical • HEOR • P2 data • Acne Vulgaris • Metabolic Disorders • Polycystic Ovary Syndrome • CRP

Progestogen Experience Among Transgender Women and Gender Diverse Adults Assigned Male at Birth in the United States. (PubMed, Endocr Pract) - "In the largest survey describing progestogen experience in E-GAHT to date, over half of TGD AMAB adults used progestogens. While most report satisfaction with use, further objective evidence on the benefits of progestogens is needed to clarify its clinical impact as part of E-GAHT."

Journal • Cardiovascular • Hematological Disorders • Pain • Pulmonary Embolism • Respiratory Diseases

Exogenous estradiol increases cardiovagal baroreflex sensitivity during a hypertensive stimulus in premenopausal young women. (PubMed, Am J Physiol Heart Circ Physiol) - "After 4 days of hormone suppression participants were given either 0.1-0.2 mg transdermal estradiol (E2) or 200 mg oral micronized progesterone (P4) per day...CVBRS slope during the hypotensive (sodium nitroprusside) and hypertensive (phenylephrine) phases of the modified Oxford were also assessed...Interestingly, the E2 group's CVBRS increased in response to the hypertensive stimulus while the P4 group had no change. These data suggest that estradiol alone augments CVBRS to a hypertensive stimulus, but progesterone alone and combined E2 and P4 do not change CVBRS."

Journal • Cardiovascular

Progesterone and Tobacco Use Among Postpartum People with Methamphetamine Use Disorder: Secondary Analysis of A Pilot Randomized Controlled Trial (CPDD 2025) - P1 | " This is a secondary analysis of a double-blind, randomized-controlled trial of people with MUD within 12 weeks postpartum comparing oral micronized progesterone to placebo and reduction of methamphetamine use and craving (NCT05128071). In this trial, we found that a micronized progesterone intervention among individuals with MUD, did not significantly reduce postpartum tobacco use; future studies should be powered for this outcome."

Clinical • Long-acting Reversible Contraceptives • Substance Abuse

The effect of low-dose cyclic 17-ß-estradiol administration on bone turnover in healthy postmenopausal women: a randomized controlled trial (ESPE-ESE 2025) - "All participants also received continuous oral micronized progesterone 100 mg once daily. Cyclic 17-β-estradiol administration resulted in higher bone formation over time compared to continuous standard-dose administration, while bone resorption did not differ between the cyclic and continuous standard-dose group. Thus, cyclic estradiol may improve bone health in the short-term."

Clinical • Gynecology • Osteoporosis

Cytokines and Pentraxin 3 Levels in Unexplained Recurrent Pregnancy Loss: Role of Oral Micronized Progesterone Therapy as Immunomodulator on Their Levels and Pregnancy Outcome, a Prospective Comparative Study. (PubMed, J Obstet Gynaecol India) - "Women with higher levels than these can be offered progesterone therapy. Trial registration Clinical trial registry of India (CTRI/2016/09/007278)."

Journal • Immunology • IL6 • PTX3 • TNFA