Dienorette (dienogest/ethinylestradiol) / Insud Pharma - LARVOL DELTA

Long-term follow-up of the effect of oral dienogest and dienogest/ethinylestradiol treatment on cell-free DNA levels in patients with deep endometriosis. (PubMed, Eur J Med Res) - "Higher cfDNA levels were observed in DE patients at 12 months of oral hormonal treatment showing similar results with dienogest or dienogest/ethinylestradiol. This increase could be explained by apoptosis of the endometriosis foci due to the treatment."

Journal • Observational data • Endometriosis • Gynecology • Inflammation • Women's Health

Rapid and random-start endometrial preparation before outpatient hysteroscopic polypectomy in patients of perimenopausal age. (PubMed, Climacteric) - P4 | "This study aimed to assess the efficacy of randomly started oral dienogest/ethinylestradiol (DNG/EE) for swift endometrial preparation prior to outpatient hysteroscopic polypectomy in perimenopausal women...DNG/EE treatment offers rapid, cost-effective endometrial preparation, enhancing surgical outcomes and patient satisfaction during outpatient polypectomy. ClinicalTrials.gov NCT06316206."

Journal • Gynecology • Women's Health

Comparison of dienogest or combinations with ethinylestradiol/estradiol valerate on the pain score of women with endometriosis: A prospective cohort study. (PubMed, Medicine (Baltimore)) - "The recommended pain medications are oral hormonal contraceptives, progestin therapy, danazol, gonadotropin-releasing hormone analogs, nonsteroidal anti-inflammatory drugs, and aromatase inhibitors...Patients were divided into 3 groups (20 patients in each medication group) according to the given medication: cyclic DNG (Visanne) or 0.03 mg ethinylestradiol combined with 2 mg DNG (Dienille) or estradiol valerate combined with 2 mg DNG (Qlarista)...However, statistically, significant decreases were seen in the cyst size and VAS score, indicating response to therapy in all groups. In conclusion, we think it is more reasonable to use cost-effective oral contraceptive medications, which also cause common side effects, instead of costing DNG since all drugs have the same efficiency and success."

Clinical • Journal • Observational data • Endometriosis • Gynecology • Musculoskeletal Pain • Obstetrics • Oncology • Pain • 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 Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation (clinicaltrials.gov) - P4 | N=103 | Completed | Sponsor: University of Palermo

New P4 trial • Women's Health

A Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, and Tolerability of LPRI-424, 13 Cycles (clinicaltrials.gov) - P3 | N=1034 | Completed | Sponsor: Insud Pharma | Active, not recruiting ➔ Completed

Trial completion

A Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, and Tolerability of LPRI-424, 13 Cycles (clinicaltrials.gov) - P3 | N=1034 | Active, not recruiting | Sponsor: Insud Pharma | Trial completion date: Jun 2023 ➔ Sep 2023

Trial completion date

Correlation between ETP-based APC Resistance and the Relative Risk of Venous Thromboembolism in Women Using Combined Oral Contraceptives (ISTH 2023) - "Values from non-COC (n=56) and COC users (ethinylestradiol (EE) with levonorgestrel (n=23 for EE 20µg, n=34 for EE 30µg), desogestrel (n=25 for EE 20µg, n=6 for EE 30µg) or with cyproterone acetate (n=6)) were used to build the VTE prediction model. The model showed a Spearman's rank correlation of 0.94 (Figure 1). Based on this model, VTE RR estimates were 3.55 for ethinylestradiol/dienogest, 1.66 for estradiol/nomegestrol acetate and 1.59 for estetrol/drospirenone versus non-COC users. Conclusion(s): The model predicted RR estimates concordant with recently published post marketing surveillance data comparing COC VTE risk versus non-COC users."

Clinical • Relative risk • Cardiovascular • Venous Thromboembolism

Quality of life and clinical factors in women with endometriosis, the role of dienogest vs EE/dienogest over time: a single-center study. (PubMed, Arch Gynecol Obstet) - "DUE and pain are important variables related to psychological aspects of women with endometriosis. Treatment with both DNG and EE/DNG may have positive effects on the QoL, HRQoL and symptoms. Moreover, DNG seems to have a greater effect than EE/DNG on dyspareunia reduction over time."

HEOR • Journal • Endometriosis • Gynecology • Musculoskeletal Pain • Pain • Women's Health

A Pivotal, Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, Tolerability of LPRI-424, 13 Cycles (clinicaltrials.gov) - P3 | N=1034 | Active, not recruiting | Sponsor: Insud Pharma | Unknown status ➔ Active, not recruiting | Trial completion date: Oct 2021 ➔ Jun 2023 | Trial primary completion date: Oct 2021 ➔ Jun 2023

Enrollment closed • Trial completion date • Trial primary completion date

A clinical study in women suffering from polycystic ovary syndrome (PCOS) to test the drug LPRI-424 (dienogest/ethinyl estradiol) during 9 months of treatment (clinicaltrialsregister.eu) - P3; N=367; Sponsor: Chemo Research S.L.

Clinical • New P3 trial • Polycystic Ovary Syndrome

Ethinyl Estradiol vs Estradiol Valerate in Combined Oral Contraceptives - Effect on Glucose Tolerance: A Randomized, Controlled Clinical Trial. (PubMed, Contraception) - P4 | "We found no clinically significant differences between EV and EE combined with DNG and DNG-only on glucose tolerance in healthy, young, normal-weight women, indicating that these preparations appear close to neutral regarding glucose metabolism when used continuously for nine weeks. Trial registration number EU Clinical trials register, EudraCT 2014-001243-20; ClinicalTrials.gov, NCT02352090. Implications Combinations of both ethinyl estradiol and natural estradiol (estradiol valerate) with dienogest (DNG), as well as DNG-only, seem metabolically safe in young and healthy women in short-term continuous use."

Clinical • Journal

A Pivotal, Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, Tolerability of LPRI-424, 13 Cycles (clinicaltrials.gov) - P3; N=995; Recruiting; Sponsor: Insud Pharma; Not yet recruiting ➔ Recruiting; Trial completion date: Mar 2021 ➔ Oct 2021; Trial primary completion date: Dec 2020 ➔ Oct 2021

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Long-acting Reversible Contraceptives

A clinical study for testing the contraceptive efficacy, tolerability and safety of dienogest 2 mg / ethinyl estradiol 0.02 mg during nine cycles in comparison with drospirenone 3 mg / ethinyl estradiol 0.02 mg A vizsgálat az LPRI-424 (2 mg dienogeszt / 0,02 mg etinilösztradiol) fogamzásgátló hatásosságát, tolerálhatóságát és biztonságosságt vizsgálja kilenc cikluson át, 3 mg drospirenon /... (clinicaltrialsregister.eu) - P3; N=1018; Ongoing; Sponsor: Chemo Research S.L.

Clinical • New P3 trial

A clinical study for testing the contraceptive efficacy, safety, tolerability and pharmacokinetics of dienogest 2 mg / ethinyl estradiol 0.02 mg during 13 cycles (clinicaltrialsregister.eu) - P3; N=850; Ongoing; Sponsor: Chemo Research S.L.

Clinical • New P3 trial