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drospirenone (Slinda / LPRICF113 / LF111)

✓ Approved

HyundaiPharm · ESR1 · Steroids

What is drospirenone?

drospirenone is a steroids developed by HyundaiPharm. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesSlinda, LPRICF113, LF111
CompanyHyundaiPharm
Drug ClassSteroids, Small Molecule
Molecular TargetESR1, ESR2, NR3C2, PGR
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, HyundaiPharm

Mechanism of Action

Molecular Targets

drospirenone acts on 4 molecular targets:

ESR1estrogen receptor 1 (ER, ESR)
ESR2estrogen receptor 2 (ESTRB, ER-BETA)
NR3C2nuclear receptor subfamily 3 group C member 2 (NR3C2VIT, MR)
PGRprogesterone receptor (NR3C3, PR)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

drospirenone is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Reproductive system and breast disordersDysmenorrhoeaPhase II

Related Research Articles

PubMedEuropean journal of obstetrics, gynecology, and reproductive biology2026-11-03

User satisfaction with Estetrol/Drospirenone combined oral contraception: A prospective observational study.

Pinto Pedro Viana PV, Gomes Carolina C, Pinho Ana M D AMD, Bombas Teresa T et al.

This study evaluated women's overall satisfaction with a combined oral contraceptive containing estetrol 15 mg/drospirenone 3 mg (E4/DRSP) in clinical practice. This prospective, multicentre, six-cycle, non-interventional study included women aged 18-45 years who initiated hormonal contraception (starters) or switched from another hormonal contraceptive (switchers) to E4/DRSP. Of 380 women starting E4/DRSP, 201 (52.9%) were switchers and 226 (59.5%) completed the six-cycle follow-up. In women with available follow-up data, satisfaction with E4/DRSP was high at Cycle 6 (starters 76.9% [95% CI 68.3-84.0], switchers 72.0% [95% CI 63.5-79.5]), with no significant differences between groups or over time (p > 0.05). Users reported a stable profile across well-being, mood, sexual life, premenstrual period and skin condition. Starters experienced significant improvements in breast tenderness between Cycles 3 and 6 (p = 0.024). Satisfaction with the cycle pattern improved significantly in both groups between baseline and Cycle 3, and baseline and Cycle 6 (all p < 0.05). Adherence among respondents was significantly higher for switchers (95.8%) than starters (83.3%) at Cycle 6 (p = 0.022), and approximately 80% of respondents intended to continue using E4/DRSP. Sixty-six women (17.4% [95% CI 13.6-21.2]) reported discontinuing E4/DRSP because of adverse events (AEs). The types of AEs most reported were consistent with those described in Phase 3 trials, with no new safety signals reported. Among women who completed six cycles of follow-up, E4/DRSP users reported high satisfaction, high intention to continue use, and an AE profile generally consistent with that described in Phase 3 trials.

PMID 42976648
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PubMedOpen access journal of contraception2026-11-03

Impact of Hormonal Contraceptive Exposure on Pancreatic β-Cell Adaptation and Glucose Homeostasis: A Systematic Review.

Niyomugabo Aime Patrick AP, Onaadepo Olufunke O, Ntakirutimana Leopold L, Birhanie Muluken Walle MW et al.

Hormonal contraceptives (HCs) modulate endocrine and metabolic function. Some formulations have been associated with reduced insulin sensitivity, increasing the functional demand on pancreatic β-cells. This systematic review synthesised evidence on pancreatic β-cell adaptation to HC exposure. In accordance with PRISMA 2020, PubMed, Scopus and Wiley Online Library were searched for records published from January 2000 to December 2025, combining terms for β-cell function and adaptation with terms for hormonal contraceptives and for glucose homeostasis and insulin resistance. Eligible studies were original investigations in humans and rodents examining β-cell structural, functional or signalling adaptation to HC exposure, with a comparison group or pre-exposure baseline. Risk of bias was assessed by design using RoB 2, NIH and Newcastle-Ottawa criteria, SYRCLE, and adapted in vitro indicators. Findings were synthesised thematically. Of 502 records identified, seven studies met the criteria: four human, two rodent in vivo and one isolated islet study. In women, ethinylestradiol with norgestimate improved insulin sensitivity in lean participants but reduced it in those with obesity; a drospirenone-containing pill raised HOMA-IR; an oral levonorgestrel preparation reduced insulin sensitivity more than an etonogestrel vaginal ring, with β-cell function unaltered by either; and androgenic formulations amplified postprandial glucose and insulin responses despite unchanged fasting values. In rodents, drospirenone-containing exposure produced hyperinsulinemia with preserved glucose tolerance, attributable to enhanced secretory activity and reduced insulin clearance; levonorgestrel impaired glucose tolerance and raised HOMA-IR, HOMA-β and circulating corticosterone. In isolated rat islets, gestodene metabolites increased insulin and glucokinase expression and glucose-stimulated insulin secretion via oestrogen receptor-dependent pathways. Effects of HC on glucose metabolism and β-cell function appear to depend on progestin composition, route of administration and pre-existing metabolic status. Longitudinal human studies using direct measures of secretory capacity are needed to establish whether compensatory capacity is sustained under continued exposure.

PMID 42974476
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PubMedResearch and practice in thrombosis and haemostasis2026-10-31

Signal of venous thromboembolism with ethinyl estradiol vs natural estrogens in oral contraceptives: analysis of the EudraVigilance and Food and Drug Administration Adverse Events Reporting System databases.

Raskin Lucie L, Didembourg Marie M, Locquet Médéa M, Morimont Laure L et al.

Disproportionality analyses in the Food and Drug Administration Adverse Events Reporting System (FAERS) and EudraVigilance reported lower reporting of venous thromboembolism (VTE) with natural estrogen-based combined oral contraceptives (COCs) than with ethinylestradiol/levonorgestrel. However, using ethinylestradiol/levonorgestrel as the reference showed reduced reporting only for natural estrogen-based products. We therefore reanalyzed both databases separately, using natural estrogen-based COCs as the reference. Previously extracted individual case safety report datasets and published disproportionality analyses were re-examined, using natural estrogen-based contraceptives as the comparator. Proportional reporting ratios (PRRs) were recalculated separately for each database. COCs were categorized as ethinylestradiol-based or natural estrogen-based formulations. Drospirenone-only pills were included for comparison. Analyses used pooled natural estrogen contraceptives, estetrol/drospirenone, or estradiol/dienogest as reference groups. Disproportionality was defined as PRR >2, at least 3 cases, and χ2 ≥ 4. Consistent patterns were observed in EudraVigilance and FAERS. Compared with natural estrogen-based COCs, ethinylestradiol-based COCs showed a disproportionate reporting of VTE (EudraVigilance: PRR, 5.10 [95% CI, 4.68-5.56]; FAERS: PRR, 4.21 [95% CI, 3.49-5.08]). In EudraVigilance, when using estetrol/drospirenone as the reference, all ethinylestradiol-based formulations showed disproportionality according to the conventional PRR threshold. A similar trend was noted in FAERS, though not statistically significant, with the drospirenone-only formulation comparable to estetrol/drospirenone. This analysis revealed a consistent and disproportionate reporting of VTE associated with ethinylestradiol-based COCs compared with natural estrogen-based alternatives across 2 pharmacovigilance databases. These results, together with prior biological and observational research, support further reevaluation of COC options given the estrogenic component's potential influence on VTE risk.

PMID 42965049
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PubMedTaiwanese journal of obstetrics & gynecology2026-10-28

Efficacy of estetrol (E4) 15 mg/ drospirenone (DRSP) 3 mg combination for the treatment of dysmenorrhea in women with recurrent endometriosis and/or adenomyosis.

Lo Ya-Shun YS, Hsu Le-Tien LT, Wu Hsien-Ming HM, Huang Hong-Yuan HY

To evaluate the efficacy and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg in the treatment of dysmenorrhea associated with recurrent endometriosis and/or adenomyosis. This retrospective observational study reviewed the medical records of 23 women undergoing E4/DRSP treatment. Among them, 14 patients with recurrent endometriosis and/or adenomyosis who completed at least 16 weeks of treatment were analyzed. The primary outcome was the change in endometriosis-associated pain severity, assessed using a visual analogue scale (VAS). Secondary outcomes included changes in serum estradiol and cancer antigen 125 (CA-125) levels, as well as patient-reported quality of life. Biochemical data were available for 11 patients. Statistical analysis was performed using paired t-tests, with significance defined as p < 0.05. The mean baseline VAS score was 7.7 with 95% confidence interval (CI) 6.9 to 8.6, which decreased significantly to 3.3 (95% CI, 2.3 to 4.3) after treatment (p < 0.005). The average VAS responder rate was 55.8%, with 85.7% of patients achieving a ≥30% reduction and defined as responder. Serum estradiol levels significantly declined (p = 0.024), from 214 pg/ml (95%CI, 34.7-394.1 pg/ml) to 42.7 pg/ml (95% CI, 2.23-83.2 pg/ml), whereas CA-125 showed a nonsignificant downward trend. No serious adverse events occurred. A total of 86% of patients reported improved quality of life. The E4/DRSP combination regimen appears to be an effective and well-tolerated treatment for dysmenorrhea in women with recurrent endometriosis and/or adenomyosis. It may serve as a viable long-term hormonal option, for those intolerant or have contraindications to conventional therapies.

PMID 42951459
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PubMedAmerican journal of obstetrics and gynecology2026-10-25

Assessing the Safety of Estro-Progestin and Progestin-only drugs: A Signal Detection Study of Meningioma Reports in EudraVigilance.

Manuzzi Alice A, Fazio Elena E, Nikitina Victoria V, Broccoli Massimiliano M et al.

Exogenous hormonal therapies are used for contraception and for several gynecologic and menopausal indications, frequently for prolonged periods. Previous epidemiological studies have reported an increased risk of meningioma with some progestins, particularly following prolonged exposure and high cumulative doses. It is a common intracranial tumor with marked female predominance, suggesting a potential role of hormones in its pathogenesis and growth. Most meningiomas are located in the anterior or middle skull base, where a higher prevalence of progesterone receptors has been observed. This evidence further underlines the relationship between hormonal factors and this type of intracranial tumor. Moreover, rapid and spontaneous tumor regression has been reported after cessation of treatment with exogenous hormones or when serum progestogen levels decrease due to physiological factors. This study aimed to investigate the presence of a safety signal for meningioma among users of estro-progestin and progestin-only therapies using pharmacovigilance data. Data from the EudraVigilance database were analyzed using both descriptive and statistical approaches. Three complementary disproportionality methods were applied to strengthen signal detection: Reporting Odds Ratio (ROR), Information Component (IC), and Empirical Bayes Geometric Mean (EBGM). The study period covered the last ten years, from January 1, 2016, to December 31, 2025. The drugs analyzed included: drospirenone-ethinylestradiol combination, dienogest-ethinylestradiol combination, drospirenone-only, desogestrel and levonorgestrel. We included all reports in which these drugs were recorded as suspected, excluding those in which they were reported only as concomitant drugs. A total of 21,091 reports, corresponding to 70,476 drug-ADR pairs, were identified. As expected, most reports concerned female patients, consistent with both the indication of these therapies and the known higher prevalence of meningioma in women. Disproportionality signals were identified for drospirenone and desogestrel-only formulations, suggesting a potential association with meningioma: A disproportionality signal was identified for desogestrel-only pills (110 reports; ROR 11.11, 95% CI 8.79-14.06; IC025 2.64; EB05 5.79). A novel exploratory signal also emerged for drospirenone-only pills (8 reports; ROR 2.41, 95% CI 1.19-4.89; IC025 0.54; EB05 1.17). No disproportionality signal was detected for the two combined formulations or levonorgestrel; absence of a signal should not be interpreted as absence of risk or evidence of comparative safety. In addition to meningioma, other serious adverse drug reactions - including known cardiovascular events and previously unreported reactions - were identified, warranting further investigation. These findings highlight the importance of ongoing pharmacovigilance activities and careful benefit-risk evaluation of hormonal therapies, particularly given their widespread and long-term use and the potential for rare but serious outcomes such as meningioma. This analysis identified new but exploratory safety signals that warrant confirmation in studies with valid exposure denominators, longitudinal treatment histories, latency assessment, and control of confounding. The findings should not be used alone to infer causality or guide comparative clinical decisions.

PMID 42925942
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PubMedAnnales d'endocrinologie2026-10-23

Cardiovascular and thromboembolic risks of sex hormone therapy: from contraception to transgender care.

Bonnet Fabrice F, Vaduva Patricia P, Dosda Arnaud A

The risk of venous thromboembolism is increased with combined oral contraceptives, rises with the dose of ethinylestradiol, and is higher with desogestrel, gestodene, drospirenone or cyproterone acetate than with levonorgestrel; the determinant is not the generation of the pill but the residual androgen-receptor activity of the progestin, which modulates the hepatic effect of the estrogen. Age over 35 years, obesity, smoking and a family history of thrombosis amplify it. Pills based on a native estrogen have a more limited hepatic impact and rank below most ethinylestradiol combinations in contemporary cohorts, but their clinical safety is not demonstrated and no comparative outcome data exist for estetrol/drospirenone. Androgenicity is not a general marker of venous safety: injectable depot medroxyprogesterone acetate, given alone at supraphysiological doses, carries an increased risk. Myocardial infarction and stroke are also more frequent, but against a very low background - about 21 additional strokes and 10 additional infarctions per 100,000 person-years, four times fewer than the venous excess - and, unlike venous events, independent of progestin type. Menopause hormone therapy increases venous thromboembolic risk, especially in the first year; the route of administration is the main determinant, transdermal estradiol with micronized progesterone appearing safest. In cisgender men, testosterone deficiency carries increased cardiovascular risk, and randomized and real-world data support the safety of transdermal replacement, although more pulmonary embolism and atrial fibrillation have been observed. In trans women, observational data show an increased risk of stroke and venous thromboembolism, particularly with oral estradiol and cyproterone acetate, whereas recent large-scale data show no excess of major cardiovascular events with testosterone in trans men. The practical consequences are specific: no combined pill is acceptable after a venous thromboembolic event, with a thrombogenic mutation or with migraine with aura, native-estrogen pills included; transdermal estradiol should be preferred for menopause and feminising hormone therapy; and haematocrit should guide the dose and route of testosterone.

PMID 42918571
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