NCT05751876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
Last Updated

March 2, 2023

Status Verified

July 1, 2022

Enrollment Period

3.3 years

First QC Date

February 13, 2023

Last Update Submit

February 28, 2023

Conditions

AdenomyosisMedication Adherence

Keywords

AdenomyosisPerimenopauseDienogest

Outcome Measures

Primary Outcomes (1)

  • 1 year dienogest use

    successfully long-term (more than a year) dienogest use

    September 2018 and December 2021

Study Arms (1)

Women with adenomyosis under dienogest

Perimenopausal women with symptomatic adenomyosis receiving dienogest

Drug: Dienogest

Interventions

DienogestDRUG

Dienogest 2mg was prescribed once per day orally

Also known as: Visanne, Bayer
Women with adenomyosis under dienogest

Eligibility Criteria

Age40 Years - 53 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women with adenomyosis who did not want further childbearing and received dienogest treatment for dysmenorrhea and/or hypermenorrhea

You may qualify if:

  • Women with adenomyosis who did not want further childbearing and received dienogest treatment for dysmenorrhea and/or hypermenorrhea

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (5)

  • 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.

    PMID: 35123042RESULT

  • 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.

    PMID: 32767677RESULT

  • 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.

    PMID: 33590656RESULT

  • 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.

    PMID: 34961515RESULT

  • 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.

    PMID: 29845696RESULT

MeSH Terms

Conditions

AdenomyosisMedication Adherence

Interventions

dienogest

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Chi-Hau Chen, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2023

First Posted

March 2, 2023

Study Start

September 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 2, 2023

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

The datasets analyzed during the study are available from the corresponding author on reasonable request.

Locations

TW(1)