Clinical trial NCT05751876: Dienogest in Perimenopausal Women With Adenomyosis
Official title: Clinical Experience of Dienogest in Perimenopausal Females With Symptomatic Adenomyosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenomyosis
Medication Adherence
Keywords: Adenomyosis
Perimenopause
Dienogest
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 87
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with adenomyosis who did not want further childbearing and received dienogest treatment for dysmenorrhea and/or hypermenorrhea

Brief summary: 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.

Detailed description: 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. The baseline demographic data included age, parity, delivery mode, and body mass index. Sonographic findings of adenomyosis, uterine size, and other gynecological lesions were recorded. Indications for dienogest treatment were analyzed, and women for pre-operative control or post-operative prevention of endometrioma were excluded. Women who were younger than 40 years old, with a post-treatment follow-up duration of fewer than 6 months, and medical conditions not suitable for dienogest treatment, such as known breast cancer, high thromboembolic effect, and smoking, were also excluded. The patients were further allocated into a younger group (more or equal to 40 years old and less than 45 years old) and an older group (more or equal to 45 years old to menopause).

For women with symptomatic adenomyosis, the pain scales and pretreatment data, including hormonal status, complete blood cell counts, liver function tests, and cancer antigen 125 (CA-125) as an indicator of endometriosis were recorded. Previous conservative treatment for adenomyosis was also reviewed. 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. During the treatment, blood tests and pelvic sonography would be performed every 6 months. Besides, a personal interview was also done for treatment effect evaluation and adverse effect management. Once the patient decided to discontinue the treatment, the follow-up started. The post-treatment follow-up interval was defined as the time frame between the day she stopped the dienogest treatment and her last visit on the medical record. The follow-up would include clinical symptoms of adenomyosis and laboratory or sonographic data if necessary. Menopause was defined when the FSH level was more than 30 mIU/mL with menopausal symptoms, such as hot flush, and no menstrual bleeding after stopping dienogest for a year.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1 year dienogest use
timeFrame: September 2018 and December 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chi-Hau Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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;29(5):602-612. doi: 10.1016/j.jmig.2021.11.024. Epub 2022 Feb 2.
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. Epub 2020 Sep 18.
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.
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.
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. doi: 10.1111/jog.13674. Epub 2018 May 29.