Completed

Clinical Experience of Dienogest in Perimenopausal Females With Symptomatic Adenomyosis

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Treatment Adherence and Compliance+10

+ Urogenital Diseases

+ Genital Diseases

From 40 to 53 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2018
See protocol details

Summary

Principal SponsorNational Taiwan University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2018

Actual date on which the first participant was enrolled.

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 TitleClinical Experience of Dienogest in Perimenopausal Females With Symptomatic Adenomyosis
NCT05751876
Principal SponsorNational Taiwan University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

87 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 40 to 53 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Treatment Adherence and ComplianceUrogenital DiseasesGenital DiseasesBehaviorFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemalePatient Acceptance of Health CarePatient ComplianceUterine DiseasesHealth BehaviorFemale Urogenital DiseasesMedication AdherenceAdenomyosis

Criteria

1 inclusion criteria required to participate
Women with adenomyosis who did not want further childbearing and received dienogest treatment for dysmenorrhea and/or hypermenorrhea

3 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

National Taiwan University Hospital

Taipei, TaiwanOpen National Taiwan University Hospital in Google Maps
CompletedOne Study Center
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