Medication Adherence Clinical Trial
Official title:
Clinical Experience of Dienogest in Perimenopausal Females With Symptomatic Adenomyosis
Verified date | July 2022 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Between September 2018 and December 2021, women who did not want further childbearing and received dienogest treatment for dysmenorrhea and/or hypermenorrhea were included in a retrospective chart review. Dienogest 2mg was prescribed once per day orally after completing the above-mentioned exam. The patient would return to our clinic on the 1st, 3rd, and 6th then every 3 months for a prescription. The primary outcome was successfully long-term (more than a year) dienogest use for pain and/or bleeding control. The secondary outcomes were the reasons for discontinuing dienogest treatment and the predictor of successful long-term treatment.
Status | Completed |
Enrollment | 87 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 53 Years |
Eligibility | Inclusion Criteria: - Women with adenomyosis who did not want further childbearing and received dienogest treatment for dysmenorrhea and/or hypermenorrhea Exclusion Criteria: - < 40 y/o - Post-operative prevention of endometriosis recurrence - Medical conditions not suitable for dienogest treatment, such as known breast cancer, high thromboembolic effect, and smoking |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Chiu CC, Hsu TF, Jiang LY, Chan IS, Shih YC, Chang YH, Wang PH, Chen YJ. Maintenance Therapy for Preventing Endometrioma Recurrence after Endometriosis Resection Surgery - A Systematic Review and Network Meta-analysis. J Minim Invasive Gynecol. 2022 May;2 — View Citation
Miyagawa C, Murakami K, Tobiume T, Nonogaki T, Matsumura N. Characterization of patients that can continue conservative treatment for adenomyosis. BMC Womens Health. 2021 Dec 28;21(1):431. doi: 10.1186/s12905-021-01577-x. — View Citation
Neriishi K, Hirata T, Fukuda S, Izumi G, Nakazawa A, Yamamoto N, Harada M, Hirota Y, Koga K, Wada-Hiraike O, Fujii T, Osuga Y. Long-term dienogest administration in patients with symptomatic adenomyosis. J Obstet Gynaecol Res. 2018 Aug;44(8):1439-1444. do — View Citation
Nirgianakis K, Vaineau C, Agliati L, McKinnon B, Gasparri ML, Mueller MD. Risk factors for non-response and discontinuation of Dienogest in endometriosis patients: A cohort study. Acta Obstet Gynecol Scand. 2021 Jan;100(1):30-40. doi: 10.1111/aogs.13969. — View Citation
Ono N, Asano R, Nagai K, Sugo Y, Nakamura T, Miyagi E. Evaluating the safety of dienogest in women with adenomyosis: A retrospective analysis. J Obstet Gynaecol Res. 2021 Apr;47(4):1433-1440. doi: 10.1111/jog.14612. Epub 2021 Feb 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1 year dienogest use | successfully long-term (more than a year) dienogest use | September 2018 and December 2021 |
Status | Clinical Trial | Phase | |
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