NCT05697471

Brief Summary

The aim of this study is to evaluate the efficacy between dienogest and danazol.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2023

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 1, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

February 25, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 29, 2023

Status Verified

January 1, 2023

Enrollment Period

2.8 years

First QC Date

January 1, 2023

Last Update Submit

March 27, 2023

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • The change of severity in dysmenorrhea

    Between-group difference in the score of global response assessment of dysmenorrhea

    16 weeks

Secondary Outcomes (3)

  • The change of severity in urinary symptoms

    16 weeks

  • The change of severity in quality of life related to urinary symptoms

    16 weeks

  • The change of severity in menstrual amount

    16 weeks

Study Arms (2)

Dienogest

EXPERIMENTAL
Drug: Dienogest

Danazol

ACTIVE COMPARATOR
Drug: Danazol

Interventions

DienogestDRUG

Dienogest 2 mg per day

Dienogest
DanazolDRUG

Danzol 200MG per day

Danazol

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 20 years old
  • Have an endometriosis-related condition (including adenomyosis, adenomyoma, ovarian endometrioma, or pelvic endometriosis).

You may not qualify if:

  • Minors.
  • Have a history of breast cancer or other cancers.
  • Patients with vascular obstruction such as stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

dienogestDanazol

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Sheng-Mou Hsiao, MD

CONTACT

+886289667000smhsiao2@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 26, 2023

Study Start

February 25, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 29, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)