Evidence map›Paper›PMID 41915378›Full record

ArticleClinical drug investigation2026

Effects of Ensitrelvir on the Pharmacokinetics of Combined Oral Contraceptives (Ethinyl Estradiol/Drospirenone) in Healthy Adult Women: A Phase 1 Fixed-Sequence, Multiple-Dose, Drug-Drug Interaction Study.

Ryosuke Shimizu, Risa Yokokawa Shibata, Ryuji Kubota, Sho Okuda, Takuhiro Sonoyama

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical drug investigation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06775730 (A Phase 1 Drug-Drug Interaction Study of S-217622 With Combined Oral Contraceptives in Healthy Adult Female Participants), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06775730 phase1completednot on this map

A Phase 1 Drug-Drug Interaction Study of S-217622 With Combined Oral Contraceptives in Healthy Adult Female Participants

TypeinterventionalSponsorShionogiRan2024 to 2025Enrolled24ConditionsHealthy Adult Female ParticipantsArmsEnsitrelvir
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Ryosuke ShimizuMedical Science Department, Shionogi & Co., Ltd., Grand Green Osaka South Building Park Tower, 5-54 Ofuka-cho, Kita-ku, Osaka, 530-0011, Japan. ryosuke.shimizu@shionogi.co.jp.ORCID http://orcid.org/0000-0001-9666-8678
Risa Yokokawa ShibataMedical Science Department, Shionogi & Co., Ltd., Grand Green Osaka South Building Park Tower, 5-54 Ofuka-cho, Kita-ku, Osaka, 530-0011, Japan.
Ryuji KubotaMedical Science Department, Shionogi & Co., Ltd., Grand Green Osaka South Building Park Tower, 5-54 Ofuka-cho, Kita-ku, Osaka, 530-0011, Japan.
Sho OkudaClinical Research Department, Shionogi & Co., Ltd., Osaka, Japan.
Takuhiro SonoyamaMedical Science Department, Shionogi & Co., Ltd., Grand Green Osaka South Building Park Tower, 5-54 Ofuka-cho, Kita-ku, Osaka, 530-0011, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveEnsitrelvir has shown cytochrome P450 3A (CYP3A) inhibitory/induction potential in in vitro studies. This open-label, fixed-sequence Phase 1 study evaluated potential drug-drug interactions between ensitrelvir and a combined oral contraceptive (COC) containing ethinyl estradiol (EE) and drospirenone in healthy women of childbearing age.

methodsHealthy premenopausal women received EE/drospirenone (0.02 mg/3 mg) on days 1-24. Ensitrelvir was co-administered on day 20 (375 mg) and days 21-24 (125 mg/day). Blood samples were collected on days 19, 20, and 24 to assess plasma EE, drospirenone, and ensitrelvir concentrations. The primary endpoint was evaluation of the maximum plasma concentration, time to maximum plasma concentration, and area under the plasma concentration-time curve over the dosing interval τ (AUC

resultsThe safety and pharmacokinetic parameter population comprised 24 and 23 participants, respectively. Compared with day 19, AUC

conclusionEnsitrelvir has no clinically meaningful effect on the pharmacokinetics of EE and drospirenone, and the combination was well tolerated. These findings support the co-administration of ensitrelvir with COCs in clinical practice.

trial registrationNCT06775730.

Indexed as

AndrostenesContraceptives, Oral, CombinedEthinyl EstradiolIndazolesTriazinesTriazolesAdolescentAdultArea Under CurveDrug CombinationsDrug InteractionsFemaleHumansYoung AdultAndrostenesContraceptives, Oral, Combineddrospirenonedrospirenone and ethinyl estradiol combinationDrug CombinationsensitrelvirEthinyl EstradiolIndazolesTriazinesTriazoles

Identifiers

PMID41915378
PMCPMC13102736

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.