ArticleReproductive medicine and biology
Relugolix Combination Tablets in Healthy Japanese Premenopausal Women: Pharmacokinetics, Pharmacodynamics, and Safety Profile.
Article in Reproductive medicine and biology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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.
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
1 citing paper in PubMed.
- Relugolix Combination Tablets in Healthy Japanese Premenopausal Women: Pharmacokinetics, Pharmacodynamics, and Safety Profile.Reproductive medicine and biologyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: To evaluate the applicability of overseas-approved dosage of relugolix combination tablets (relugolix 40 mg, estradiol [E2] 1 mg, and norethisterone acetate 0.5 mg) in healthy premenopausal Japanese women. Methods: A randomized, double-blind phase I/II study was conducted to compare the pharmacokinetics, pharmacodynamics, and safety of repeated once-daily administration of relugolix combination tablets and relugolix (40 mg) for 6 weeks. Results: There were 26 participants in each treatment group. The mean maximum concentration and area under the concentration-time curve from time zero to 24 h ratios for relugolix (relugolix combination tablet group/relugolix group) were both approximately 0.7-0.9. The mean E2 level ranged from 20 to 50 pg/mL. There was no notable difference in luteinizing hormone or follicle-stimulating hormone levels between the two groups. There was less change from baseline in type I collagen C-terminal telopeptide concentration and a lower cumulative incidence of hot flashes in the relugolix combination tablet group compared with the relugolix group, but more participants experienced uterine bleeding (mostly spotting or light bleeding). There were no new safety concerns and relugolix combination tablets were well tolerated. Conclusion: Relugolix combination tablets have favorable safety and efficacy profiles, potentially making them suitable for long-term use in Japanese patients. Trial Registration: The trial registration number is JapicRCT2071230042.
Indexed as
Identifiers
What OpenQuestion holds
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.