Comparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis

Phase 3

Recruiting

• Conditions: Endometriosis
• Interventions: Drug: Dienogest; Drug: Danazol

• Registration Number: NCT05697471
• Lead Sponsor: Far Eastern Memorial Hospital

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.

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-01
• Study First Submitted QC: 2023-01-14
• Study First Posted: 2023-01-26
• Study Start: 2023-02-25
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dienogest	Dienogest	-
Danazol	Danazol	-

Primary Outcome Measures

Name	Time	Method
The change of severity in dysmenorrhea	16 weeks	Between-group difference in the score of global response assessment of dysmenorrhea

Secondary Outcome Measures

Name	Time	Method
The change of severity in urinary symptoms	16 weeks	Between-group difference in the score of UDI-6
The change of severity in quality of life related to urinary symptoms	16 weeks	Between-group difference in the score of IIQ-7
The change of severity in menstrual amount	16 weeks	Between-group difference in the score of global response assessment of menstrual amount

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital; 🇨🇳 Banqiao, New Taipei, Taiwan