- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05697471
Comparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis
Far Eastern Memorial Hospital
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
New Taipei
-
Banqiao, New Taipei, Taiwan, 22050
- Recruiting
- Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dienogest
|
Dienogest 2 mg per day
|
Active Comparator: Danazol
|
Danzol 200MG per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change of severity in dysmenorrhea
Time Frame: 16 weeks
|
Between-group difference in the score of global response assessment of dysmenorrhea
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change of severity in urinary symptoms
Time Frame: 16 weeks
|
Between-group difference in the score of UDI-6
|
16 weeks
|
The change of severity in quality of life related to urinary symptoms
Time Frame: 16 weeks
|
Between-group difference in the score of IIQ-7
|
16 weeks
|
The change of severity in menstrual amount
Time Frame: 16 weeks
|
Between-group difference in the score of global response assessment of menstrual amount
|
16 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endometriosis
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Estrogen Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Hormonal
- Contraceptive Agents, Male
- Danazol
- Dienogest
Other Study ID Numbers
- 111207-F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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