Pharmacokinetic study of single and multiple oral administrations of 2 mg dienogest in healthy Korean women
Non-randomised trial
OA: closed
CC0
⤵ 7 in-corpus citations
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This study investigated the pharmacokinetics of single and multiple oral doses of 2 mg dienogest in healthy Korean women.
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Abstract
BACKGROUND: The progestin dienogest was developed for oral contraception, endometriosis treatment and menopause management. Dienogest's pharmacokinetics have been primarily studied in Caucasian women. This study evaluated the single- and multiple-dose pharmacokinetics of dienogest in Korean women.
STUDY DESIGN: Sixteen healthy Korean adult women received a single administration of 2 mg dienogest, followed by multiple once-daily administrations for 14 days. The single-dose administration and the final dose of the multiple administrations were each followed by blood sampling over 60 h.
RESULTS: The mean (SD) maximum serum concentration after multiple doses of dienogest was slightly increased compared with that after a single dose [from 51.6 (9.6) to 56.6 (11.9) ng/mL], as was the area under the concentration-time curves (AUC)0-24h [from 503 (56.3) to 613 (90.7) ng ∙ h/mL]. The linearity factor calculated by AUCs of single and multiple doses is 1.00 ± 0.14, and the terminal half-life remained unchanged when single dosing and multiple dosing were compared.
CONCLUSIONS: The present study described the single- and multiple-dose pharmacokinetic profiles of dienogest in Korean women and showed linear pharmacokinetics of dienogest at steady state.
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Cited by (6)
- A Bioequivalence Trial of Dienogest in Healthy Chinese Participants Under Fed Conditions 2023
- Efficacy of Dienogest in Thinning the Endometrium Before Hysteroscopic Metroplasty and Analysis of Postoperative Reproductive Outcomes 2018
- Current understanding on pharmacokinetics, clinical efficacy and safety of progestins for treating pain associated to endometriosis 2018
- Clinical dynamics of Dienogest for the treatment of endometriosis: from bench to bedside 2017
- Dienogest for Treatment of Endometriosis in Chinese Women: A Placebo-Controlled, Randomized, Double-Blind Phase 3 Study 2017
- Endometrial preparation with Dienogest before hysteroscopic surgery: a systematic review 2016
Source provenance
- europepmc
- last seen: 2026-10-18T09:30:06.152893+00:00
- openalex
- last seen: 2026-05-11T06:39:27.580236+00:00
- pubmed
- last seen: 2026-10-08T21:11:10.042802+00:00
- unpaywall
- last seen: 2026-10-18T06:28:46.490043+00:00
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