Back to resultsComparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis
Primary Purpose
Endometriosis
Status
Recruiting
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Dienogest
Danazol
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis
Eligibility Criteria
Inclusion Criteria: > 20 years old Have an endometriosis-related condition (including adenomyosis, adenomyoma, ovarian endometrioma, or pelvic endometriosis). Exclusion Criteria: Minors. Have a history of breast cancer or other cancers. Patients with vascular obstruction such as stroke.
Sites / Locations
- Department of Obstetrics and Gynecology, Far Eastern Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dienogest
Danazol
Arm Description
Outcomes
Primary Outcome Measures
The change of severity in dysmenorrhea
Between-group difference in the score of global response assessment of dysmenorrhea
Secondary Outcome Measures
The change of severity in urinary symptoms
Between-group difference in the score of UDI-6
The change of severity in quality of life related to urinary symptoms
Between-group difference in the score of IIQ-7
The change of severity in menstrual amount
Between-group difference in the score of global response assessment of menstrual amount
Full Information
NCT ID
NCT05697471
First Posted
January 1, 2023
Last Updated
March 27, 2023
Sponsor
Far Eastern Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05697471
Brief Title
Comparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis
Official Title
Far Eastern Memorial Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Far Eastern Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the efficacy between dienogest and danazol.
Detailed Description
Objective: Women with adenomyosis or endometripsis are often suffered from dysmenorrhea or menorrhagia. Dienogest and danazol are frequently used for the treatment of endometriosis. However, there was no literature mentioned about which medication is better for the treatment of endometriosis. Thus, the aim of this study is to evaluate the efficacy between dienogest and danazol.
Methods: All consecutive women, who have endometriosis, will be randomized to receive dienogest or danazol treatment, and will assess symptoms severity, receive CA125 examination, sonographic examination at baseline, 4 weeks and 16 weeks after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dienogest
Arm Type
Experimental
Arm Title
Danazol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dienogest
Intervention Description
Dienogest 2 mg per day
Intervention Type
Drug
Intervention Name(s)
Danazol
Intervention Description
Danzol 200MG per day
Primary Outcome Measure Information:
Title
The change of severity in dysmenorrhea
Description
Between-group difference in the score of global response assessment of dysmenorrhea
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
The change of severity in urinary symptoms
Description
Between-group difference in the score of UDI-6
Time Frame
16 weeks
Title
The change of severity in quality of life related to urinary symptoms
Description
Between-group difference in the score of IIQ-7
Time Frame
16 weeks
Title
The change of severity in menstrual amount
Description
Between-group difference in the score of global response assessment of menstrual amount
Time Frame
16 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> 20 years old
Have an endometriosis-related condition (including adenomyosis, adenomyoma, ovarian endometrioma, or pelvic endometriosis).
Exclusion Criteria:
Minors.
Have a history of breast cancer or other cancers.
Patients with vascular obstruction such as stroke.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng-Mou Hsiao, MD
Phone
+886289667000
Ext
1818
Email
smhsiao2@gmail.com
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
City
Banqiao
State/Province
New Taipei
ZIP/Postal Code
22050
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng-Mou Hsiao, M.D.
Phone
+886-2-89667000
Ext
1818
Email
smhsiao2@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis
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