progesterone / Generic mfg. - LARVOL DELTA

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

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

Progesterone in Gender Affirming Hormone Therapy Study (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Emory University | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • CNS Disorders

PROSPECT: A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix (clinicaltrials.gov) - P3 | N=437 | Active, not recruiting | Sponsor: The George Washington University Biostatistics Center | Terminated ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Apr 2025

Enrollment closed • Trial completion date

Progesterone in Gender Affirming Hormone Therapy Study (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Emory University

New P2 trial • Cardiovascular • CNS Disorders

PROSPECT: A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix (clinicaltrials.gov) - P3 | N=437 | Terminated | Sponsor: The George Washington University Biostatistics Center | N=630 ➔ 437 | Trial completion date: Apr 2025 ➔ Dec 2024 | Recruiting ➔ Terminated | Trial primary completion date: Mar 2025 ➔ Oct 2024; The study was terminated due to futility.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination

Oral Dydrogesterone Versus Oral Micronized Progesterone in Threatened Miscarriage: Protocol Paper for a Randomized Controlled Trial. (PubMed, Reprod Fertil) - "Apart from incidence of treatment-emergent adverse events, safety endpoints include changes in complete blood count and results of liver function tests and kidney function tests from baseline to 14 and 24-26 weeks of gestation. Delivery outcomes are exploratory endpoints of the study."

Journal • Pain

Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant. (clinicaltrials.gov) - P=N/A | N=34 | Recruiting | Sponsor: University of Colorado, Denver | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2025 ➔ Jul 2026 | Initiation date: Apr 2024 ➔ Jul 2024 | Trial primary completion date: Apr 2025 ➔ Jul 2026

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Endocrine Disorders • Women's Health

Long-term cognitive effects of menopausal hormone therapy: Findings from the KEEPS Continuation Study. (PubMed, PLoS Med) - P4 | "In these KEEPS Continuation analyses, there were no long-term cognitive effects of short-term exposure to mHT started in early menopause versus placebo. These data provide reassurance about the long-term neurocognitive safety of mHT for symptom management in healthy, recently postmenopausal women, while also suggesting that mHT does not improve or preserve cognitive function in this population."

Clinical • Journal • Observational data