Long‐term use of dienogest for the treatment of primary and secondary dysmenorrhea
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Long-term treatment with dienogest for 52 weeks effectively reduced dysmenorrhea pain and demonstrated favorable tolerability despite frequent irregular uterine bleeding.
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Abstract
AIM: To investigate the safety and efficacy of dienogest (DNG), a progestational 19-norsteroid, administered for 52 weeks in patients with primary and secondary dysmenorrhea. METHODS: A total of 147 patients with dysmenorrhea received 1 mg of DNG orally each day for 52 weeks. The dose could be increased to 2 mg/day at or after Week 12 according to the investigator's determination. The primary safety endpoint was evaluation of adverse events, and the secondary safety endpoint was evaluation of adverse drug reactions. The number of days and severity of genital bleeding were assessed according to records in the patients' diary. Lower abdominal pain and/or low back pain because of dysmenorrhea were assessed according to the dysmenorrhea score. RESULTS: The most frequent adverse drug reaction was irregular uterine bleeding (94.6%). Most subjects completed the 52-week administration. Genital bleeding was more likely to occur in subjects with secondary dysmenorrhea than in those with primary dysmenorrhea, and in subjects with "uterine myoma or adenomyosis" than in those with "endometriosis alone." In any of the categorizations, there tended to be fewer days with genital bleeding as the treatment period increased in length, and most of the genital bleeding cases were mild. The change from baseline in the dysmenorrhea score (mean ± standard deviation [SD]) was -3.7 ± 1.6 at Week 24 of treatment and -4.0 ± 1.3 at Week 52. CONCLUSION: This study showed favorable tolerability of the long-term use of DNG to patients with dysmenorrhea and a sustainable pain relief effect.
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- Comparative Study of 0.5 mg Dienogest Tablets (1 mg/Day) and Continuous Low-Dose Estrogen/Progestin for Dysmenorrhea: A Retrospective Analysis—Influence of Bleeding-Related Factors Such as Endometrial Polyps, Uterine Fibroids, and Adenomyosis 2025
- The effect of dienogest and gonadotropin-releasing hormone agonist on pelvic pain after laparoscopic surgery for endometriosis: An RCT 2025
- Efficacy of 0.5 mg Dienogest Tablets in Treating Premenstrual Syndrome-like Symptoms: A Comparative Study with a Low-Dose Estrogen–Progestin Combination 2024
- A systematic review and Bayesian analysis of the adverse effects of dienogest 2024
- Evaluating the Efficacy and Safety of 48-Week Low-Dose Dienogest Administration in Patients With Dysmenorrhea Caused by Endometriosis: Protocol for a Randomized, Open-Label, Parallel-Group Trial (Preprint) 2024
- The use of dienogest in treatment of symptomatic adenomyosis: A systematic review and meta-analysis 2024
- Uso do dienogeste em mulheres com endometriose: uma revisão integrativa 2023
- Efficacy and safety of dienogest versus GnRH-a combined with dienogest therapy for adenomyosis 2023
- Evaluation of Endpoints Used in Clinical Trials on Adenomyosis - A Systematic Review 2023
- The Present and the Future of Medical Therapies for Adenomyosis: A Narrative Review 2023
- Modified Laparoscopic Inverted Triangle Model for Extended Lesion Resection in the Treatment of Symptomatic Localized Adenomyosis in Women Who Have Completed Childbirth 2023
- In the thicket of fears, doubts, and murky facts: some reflections on treatment modalities for endometriosis-associated pain 2023
- Risk factors of heavy uterine bleeding in patients with endometriosis and adenomyosis treated with dienogest 2023
- Aktuelle Aspekte der endokrinen Therapie der Endometriose und der Adenomyose 2023
- Rapid reduction of adenomyosis coexisting with leiomyoma volume during treatment with Relugolix 2023
- Medical Treatment of Adenomyosis 2022
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- Adenomyosis in Reproductive Years: Abnormal Uterine Bleeding and Pain 2022
- Hormonal Therapy in Endometriosis and Adenomyosis: Oral Contraceptives 2022
- The dienogest-related cystitis in women with endometriosis: a prospective, controlled, comparative study 2022
- Nonsurgical management of adenomyosis: an overview of current evidence 2022
- Meta-Analysis on the Therapeutic Effectiveness of Dienogest plus GnRH Agonist in Treating Adenomyosis and Its Related Obstetric Risk Factors 2021
- Uterine Adenomyosis: From Disease Pathogenesis to a New Medical Approach Using GnRH Antagonists 2021
- Proposal for developing treatment algorithms of women with symptomatic adenomyosis: A single‐center experience 2021
- Current and Prospective Treatment of Adenomyosis 2021
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- europepmc
- last seen: 2026-08-20T06:14:21.026120+00:00
- openalex
- last seen: 2026-06-04T00:00:01.174412+00:00
- pubmed
- last seen: 2026-05-13T22:22:17.025735+00:00
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