Comparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis

March 27, 2023 updated by: Sheng-Mou Hsiao, Far Eastern Memorial Hospital

Far Eastern Memorial Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • New Taipei
      • Banqiao, New Taipei, Taiwan, 22050
        • Recruiting
        • Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dienogest
Drug: Dienogest
Dienogest 2 mg per day
Active Comparator: Danazol
Drug: Danazol
Danzol 200MG per day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

January 1, 2023

First Submitted That Met QC Criteria

January 14, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111207-F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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