Comparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis

Endometriosis Clinical Trial

Official title:

Far Eastern Memorial Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05697471
• Other study ID #: 111207-F
• Status: Recruiting
• Phase: Phase 3
• Start date: February 25, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2023
• Source: Far Eastern Memorial Hospital
• Contact: Sheng-Mou Hsiao, MD
• Phone: +886289667000
• Email: smhsiao2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Dienogest
Dienogest 2 mg per day
• Danazol
Danzol 200MG per day

Locations

Country	Name	City	State
Taiwan	Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital	Banqiao	New Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of severity in dysmenorrhea	Between-group difference in the score of global response assessment of dysmenorrhea	16 weeks
Secondary	The change of severity in urinary symptoms	Between-group difference in the score of UDI-6	16 weeks
Secondary	The change of severity in quality of life related to urinary symptoms	Between-group difference in the score of IIQ-7	16 weeks
Secondary	The change of severity in menstrual amount	Between-group difference in the score of global response assessment of menstrual amount	16 weeks