Comparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis

Far Eastern Memorial Hospital

Status and phase: Enrolling; Phase 3

Conditions: Endometriosis

Treatments: Drug: Danazol; Drug: Dienogest

Study type: Interventional

Funder types: Other

Identifiers

NCT05697471

111207-F

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Dienogest

Experimental group

Treatment:

Drug: Dienogest

Danazol

Active Comparator group

Treatment:

Drug: Danazol