Dienogest in Perimenopausal Women With Adenomyosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Experience of Dienogest in Perimenopausal Females With Symptomatic Adenomyosis

Conditions
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Adenomyosis, Medication Adherence

Intervention / Treatment
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* Drug: Dienogest


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 53 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with adenomyosis under dienogest<br>Perimenopausal women with symptomatic adenomyosis receiving dienogest | Drug: Dienogest<br>* Dienogest 2mg was prescribed once per day orally<br>* Other names: Visanne, Bayer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 year dienogest use | successfully long-term (more than a year) dienogest use | September 2018 and December 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adenomyosis, Perimenopause, Dienogest