Utrogestan (progesterone) / Besins Healthcare - 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

FSD-IEQ-2021-03: The impact of the intensity of ovarian stimulation on embryo quality in predicted suboptimal responders. A randomized controlled trial. (clinicaltrialsregister.eu) - P4 | N=110 | Recruiting | Sponsor: Santiago Dexeus Font Fundacio Privada | Not yet recruiting ➔ Recruiting

Enrollment open • Infertility • Sexual Disorders

The effect of transdermal 17-?-estradiol/progesterone supplementation on glucose regulation in peri- and postmenopausal women with type 1 and type 2 diabetes (clinicaltrialsregister.eu) - P4 | N=48 | Recruiting | Sponsor: Amsterdam UMC Stichting

New P4 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

VNTWINC: Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix (clinicaltrials.gov) - P=N/A | N=260 | Not yet recruiting | Sponsor: National Hospital of Obstetrics and Gynecology | N=200 ➔ 260

Enrollment change

VNTWINC: Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix (clinicaltrials.gov) - P=N/A | N=260 | Not yet recruiting | Sponsor: National Hospital of Obstetrics and Gynecology

New trial

Natural Progesterone for the Treatment of Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=4 | Active, not recruiting | Sponsor: Emory University | Recruiting ➔ Active, not recruiting | N=32 ➔ 4 | Trial completion date: Aug 2026 ➔ Apr 2027 | Trial primary completion date: Aug 2025 ➔ Apr 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Gliosarcoma • Oncology • Sarcoma • Solid Tumor

LUMO: Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment (clinicaltrials.gov) - P4 | N=1008 | Recruiting | Sponsor: UMC Utrecht | Not yet recruiting ➔ Recruiting | Trial completion date: Aug 2026 ➔ Jul 2027 | Trial primary completion date: Jul 2025 ➔ Dec 2025

Enrollment open • Trial completion date • Trial primary completion date • Infertility • Sexual Disorders

A comparison of progesterone via vaginal oil capsules versus pessaries for luteal phase support in assisted reproduction treatment: a multicentre cohort study of 42 291 cycles. (PubMed, Hum Reprod) - "An appropriately powered randomized controlled trial directly comparing the two drugs, focusing on clinical efficacy, is required to determine if one is superior to the other."

Journal • Infertility

Does luteal phase support in MOH-IUI treatment improve cumulative live birth rates in couples with unexplained subfertility? Study protocol of the LUMO study: a centre, randomised, double-blind, controlled trial with cost-effectiveness analysis. (PubMed, BMJ Open) - P4 | "Participants will start study medication, applying a daily dosage of 2dd 300 mg progesterone (Utrogestan) or 2dd 300 mg placebo in vaginal capsules on the second day after the IUI procedure...It is expected that the results of this trial will be used to draft national guidelines on this issue. The study is registered in the EU CTIS trial register (2022-501534-33-00), the Dutch trial registry (registration number: LTR 24508), ClinicalTrials.gov (NCT05080569) and the WHO registry (universal trial number: U1111-1280-9461)."

Clinical protocol • HEOR • Journal • Infertility

Live birth rates are unrelated to sex-steroid levels on ET day in a dydrogesterone-based 'programmed-ovulatory FET' protocol: a multi-centric prospective cohort study. (PubMed, Hum Reprod Open) - P | "We propose the term 'Programmed-Ovulatory (PO-) FET' for this protocol. The PO-FET protocol enables scheduling the window of implantation, allows ovulation and corpus luteum formation, provides double gestagenic support, and may eliminate the need for control measurements of sex steroids on the day of FET. It allows monitoring of corpus luteum activity during the luteal phase and early pregnancy, is injection-free, and has low drug costs. This protocol needs to be tested in RCTs against other ovulatory FET protocol options, such as the 'NC FET' or 'managed NC FET'."

Journal • Endocrine Disorders

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

Is There a Need for Luteal Support in Modified Natural Cycle Frozen Embryo Transfer Cycles (clinicaltrials.gov) - P4 | N=180 | Recruiting | Sponsor: Dunamenti REK Istenhegyi IVF Center | Not yet recruiting ➔ Recruiting

Enrollment open

Droplet Size Reduction of Self-Emulsifying Drug Delivery System (SEDDS) Using the Hybrid of Medium and Long-Chain Triglycerides. (PubMed, Pharmaceutics) - "The hybrid of MCT&LCT progesterone SEDDS exhibited reduced particle size, enlarged self-emulsifying ranges, and increased drug content in the aqueous phase after lipolysis compared with the conventional mono-MCT or LCT SEDDS. In addition, the bioavailability of progesterone in the MCT&LCT SEDDS formulation was 3.82-fold higher than that of Utrogestan® (a clinical oral administrated product) in a mouse model."

Journal

What to expect from a 'standard vaginal progesterone regimen' in hormone replacement therapy frozen embryo transfer (HRT-FET) - a PRISMA review and meta-analysis. (PubMed, Reprod Biomed Online) - "Significant differences were found when comparing Cyclogest (800 mg) with Crinone (180 mg or 270 mg) (P = 0.01); Cyclogest (800 mg) with Utrogestan/Progestan (600 mg or 800 mg) (P = 0.03); and Cyclogest (800 mg) with Lutinus (300 mg) (P = 0.01). However, no significant differences were identified between products with an equivalent daily dose. In conclusion, significant differences in serum progesterone concentration exist between different vaginal progesterone products and dosing regimens, which must be taken into account when performing HRT-FET."

Journal • Retrospective data • Review

Is There a Need for Luteal Support in Modified Natural Cycle Frozen Embryo Transfer Cycles (clinicaltrials.gov) - P4 | N=180 | Not yet recruiting | Sponsor: Dunamenti REK Istenhegyi IVF Center

New P4 trial

Comparison of Pregnancy Rates in Modified Natural Frozen Embryo Transfer (FET) Cycle After Luteal Support with GnRH Agonist Versus Progesterone (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: Shaare Zedek Medical Center

New P1 trial

Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients (clinicaltrials.gov) - P4 | N=362 | Terminated | Sponsor: CRG UZ Brussel | Trial completion date: Dec 2025 ➔ Jan 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Sep 2025 ➔ Jan 2025; safety

Trial completion date • Trial primary completion date • Trial termination

DECLARED-CT: Effects of Menopausal Hormone and GLP-1 Agonist Therapy on Glucose and Energy Homeostasis in Postmenopausal Women (clinicaltrials.gov) - P=N/A | N=96 | Not yet recruiting | Sponsor: Lia Bally

New trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients (clinicaltrials.gov) - P4 | N=362 | Active, not recruiting | Sponsor: CRG UZ Brussel | Recruiting ➔ Active, not recruiting | N=522 ➔ 362

Enrollment change • Enrollment closed

Natural Progesterone for the Treatment of Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Emory University | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2024 ➔ Aug 2025

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Gliosarcoma • Oncology • Sarcoma • Solid Tumor • CD14 • CHI3L1 • CRP • FCER2 • MMP9 • PGR

SIGNIFICANCE OF SERUM DAY-3 PROGESTERONE LEVEL AFTER VAGINAL ADMINISTRATION OF DIFFERRENT PROGESTERONE REGIMENS IN HORMONE REPLACEMENT CYCLES FOR FROZEN EMBRYO TRANSFER (ASPIRE 2024) - "Serum P4 level was measured on day 3 after P-only administration.For those patients with P level ≦10 ng/mL, P augmentation with additional P (intramuscular P injection and/or oral dydrogesterone) administration was started from day 4. Conclusions There was a trend in which Utrogestan gave a high serum P level although significant difference did not exist. P augmentation with in-time combination administration of additional P may rescue the FET pregnancy outcome."

Early intrauterine pregnancy with an intrauterine device in place and terminated with spontaneous abortion: A case report. (PubMed, Medicine (Baltimore)) - "The novelty of this case report lies in the rare occurrence of an intrauterine pregnancy with a long-term IUD in place, the challenges posed by the IUD's specific location, and the complex management of threatened abortion in this context. Our case highlights the diagnostic management approach for intrauterine pregnancy with an IUD in place. Furthermore, it explores the impact of IUD location on pregnancy prognosis."

Journal • Long-acting Reversible Contraceptives • Thrombosis

Ovarian response and embryo ploidy following oral micronized progesterone-primed ovarian stimulation versus GnRH antagonist protocol. A prospective study with repeated ovarian stimulation cycles. (PubMed, Hum Reprod) - P=N/A | "In case of a freeze-all protocol, clinicians may safely consider oral micronized progesterone to control the LH surge and patients could benefit from the advantages of a medication of oral administration, with a potentially higher number of oocytes retrieved at a lower cost, without any compromise in embryo ploidy rates."

Journal

Luteal phase support using micronized vaginal progesterone as pessaries or capsules in artificial cycles: is there any difference? (PubMed, Reprod Biomed Online) - "Using MVP pessaries rather than capsules for LPS resulted in significantly fewer patients having suboptimal serum progesterone concentrations on the day of embryo transfer. Consequently, almost 50% fewer patients in the pessary group needed rescue treatment."

Journal

Preparation and formulation of progesterone para-aminobenzoic acid co-crystals with improved dissolution and stability. (PubMed, Eur J Pharm Biopharm) - "Tablets containing co-crystal were produced then compared to the Utrogestan® soft gel capsule formulation through a dissolution experiment. PROG-PABA tablets showed a substantial increase in dissolution over the course of the experiment with over 30× the amount of PROG dissolved at the 3-hour time point. This co-crystal shows positive implications for developing an improved oral PROG formulation."

Journal