Comparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis

Far Eastern Memorial Hospital

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05697471

Enrollment

120

Registered

2023-01-26

Start date

2023-02-25

Completion date

2025-12-31

Last updated

2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

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.

Interventions

DRUGDienogest

Dienogest 2 mg per day

DRUGDanazol

Danzol 200MG per day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
The change of severity in dysmenorrhea	16 weeks	Between-group difference in the score of global response assessment of dysmenorrhea

Secondary

Measure	Time frame	Description
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

Countries

Taiwan

Contacts

Primary ContactSheng-Mou Hsiao, MD

smhsiao2@gmail.com+886289667000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026