Evaluation of the efficacy, safety, and clinically recommended dose of dienogest in the treatment of primary dysmenorrhea: a randomized, double-blind, multicenter, placebo-controlled study

Yutaka Osuga, Kôichi Hayashi, Shingo Kanda
In: Fertility and Sterility · 2019 · vol. 113(1) , pp. 167–175 · doi:10.1016/j.fertnstert.2019.09.014 · PMID:31727415 · W2984916865
article OA: closed CC0 ⤵ 10 in-corpus citations
View on OpenAlex View on PubMed View at publisher
⚙ AI-generated summary by claude@2026-06, 2026-06-08 ⓘ

This randomized, double-blind, multicenter, placebo-controlled study evaluated the efficacy, safety, and clinically recommended dose of dienogest for treating primary dysmenorrhea.

One-sentence paraphrase of the abstract; not a substitute for reading it. No clinical advice. How this works

Abstract

ObjectiveTo evaluate the efficacy, safety, and clinically recommended dose of dienogest (DNG; 0.5 mg/d, 1 mg/d, and 2 mg/d) in the treatment of primary dysmenorrhea.DesignA phase II, randomized, double-blind, multicenter, placebo-controlled study.SettingTwenty study sites.PatientsA total of 235 patients with primary dysmenorrhea.Intervention(s)Patients were randomized to receive orally a placebo, DNG (0.5 mg/d, 1 mg/d, or 2 mg/d) or ethinylestradiol 0.02 mg/drospirenone 3 mg (an open-label reference drug) for 12 weeks.Main outcome measure(s)The primary endpoint was the change from baseline in the dysmenorrhea score at week 12 of treatment. The secondary endpoint was the change from baseline in the visual analogue scale at week 12 of treatment. Subjects were assessed for lower abdominal pain and/or low back pain.ResultsAll DNG arms were superior to the placebo arm in terms of the change from baseline in the dysmenorrhea score. The results suggest an equal or greater effect of DNG 1 and 2 mg/d in relieving pain, when compared to the reference drug. In the safety profile of DNG, including irregular uterine bleeding, there was no obvious difference among the doses of DNG. A significant decrease in the serum estradiol concentration compared to that in the placebo arm was not observed in the DNG 1 mg/d arm but was observed in the DNG 2 mg/d arm.Conclusion(s)The results suggest that DNG at a dose of 1 mg/d is an effective and well-tolerated treatment for primary dysmenorrhea.Trial registrationJapicCTI-152977 (en).

My notes (saved in your browser only)

Condition tags

dysmenorrhea

Citation neighborhood

Papers in the corpus that this work cites (lower rings, blue) and that cite this one (upper rings, green). Dot size scales with the paper's in-corpus citation count — bigger dot = more influential within the endo/adeno field. Click a dot to open that paper. [ expand to 2 hops ] — adds papers reached through this work's immediate citers/citees. Heavier; up to 60 extra dots.

References (33)

Cited by (10)

Source provenance

openalex
last seen: 2026-05-11T06:18:49.075943+00:00
License: CC0 · commercial use OK