Trial reportThe journal of obstetrics and gynaecology research2025
Efficacy and safety of drospirenone as a progestin-only pill in Japanese women: A phase III study.
Trial report in The journal of obstetrics and gynaecology research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Safety and Efficacy of a 24-Cycle Administration of a Drospirenone-Only Pill in Japanese Women.The journal of obstetrics and gynaecology research · 2026Trial
- Efficacy and safety of drospirenone as a progestin-only pill in Japanese women: A phase III study.The journal of obstetrics and gynaecology research · 2025Trial
- Combined Oral Contraceptive Pills Versus Progestin-Only Pills for Heavy Menstrual Bleeding: A Systematic Review.Cureus · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
aimTo evaluate the efficacy and safety of 4 mg of drospirenone (DRSP), a progestin-only pill (POP), for contraception in Japanese women.
methodsThis was a multicenter, open-label, single-arm study. The dosing period of DRSP was 13 cycles, each lasting for 28 days. In one cycle, 4 mg of DRSP was administered orally once daily for the first 24 days, followed by a placebo for 4 days.
resultsData from 276 subjects were analyzed, with a total of 3319 DRSP exposure cycles. Pregnancy occurred in one subject. The overall Pearl Index [95% CI] was 0.39 [0.01, 2.18], and the cumulative pregnancy rate [95% CI] was 0.40% [0.06, 2.81]. Of the 276 subjects, 273 (98.9%) experienced treatment-emergent adverse events (TEAEs) and 264 (95.7%) experienced adverse drug reactions. All TEAEs were mild or moderate, with no severe events. The most common TEAE was intermenstrual bleeding (irregular uterine bleeding) (89.5%). Although 31.9% of the subjects had risk factors for venous thromboembolism (VTE), no VTE-related TEAEs were observed. The incidence of unscheduled bleeding [95% CI] across all cycles was 91.6% [87.7, 94.3].
conclusionsDRSP, the first POP in Japan, is effective and safe as a contraceptive in Japanese women. It provides a new contraceptive option for Japanese women, including those at risk of VTE for whom combined oral contraceptives are contraindicated.
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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.