Comparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis

NCT ID: NCT05697471

Last Updated: 2023-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-25

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dienogest

Group Type EXPERIMENTAL

Dienogest

Intervention Type DRUG

Dienogest 2 mg per day

Danazol

Group Type ACTIVE_COMPARATOR

Danazol

Intervention Type DRUG

Danzol 200MG per day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dienogest

Dienogest 2 mg per day

Intervention Type DRUG

Danazol

Danzol 200MG per day

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Far Eastern Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sheng-Mou Hsiao

Chief, Department of Obstetrics & Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Banqiao District, New Taipei, Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sheng-Mou Hsiao, MD

Role: CONTACT

+886289667000 ext. 1818

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sheng-Mou Hsiao, M.D.

Role: primary

+886-2-89667000 ext. 1818

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

111207-F

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Adenomyosis and ART
NCT05937490 UNKNOWN PHASE4
Clinical Study on Endometrial Receptivity
NCT03687021 UNKNOWN EARLY_PHASE1
Ttt of Adenomyosis
NCT06719934 NOT_YET_RECRUITING PHASE1
Pain Associated With Endometriosis
NCT00758953 COMPLETED PHASE2