Comparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis

• Sponsor: Far Eastern Memorial Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05697471
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 35.4
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: Dienogest; Drug: Danazol	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Far Eastern Memorial Hospital
• Anticipated Study Start Date: Jan 20, 2023
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The change of severity in dysmenorrhea [16 weeks]

   Between-group difference in the score of global response assessment of dysmenorrhea

Secondary Outcome Measures

1. The change of severity in urinary symptoms [16 weeks]

   Between-group difference in the score of UDI-6

2. The change of severity in quality of life related to urinary symptoms [16 weeks]

   Between-group difference in the score of IIQ-7

3. The change of severity in menstrual amount [16 weeks]

   Between-group difference in the score of global response assessment of menstrual amount

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital	Banqiao	New Taipei	Taiwan	22050

Sponsors and Collaborators

• Far Eastern Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
• ClinicalTrials.gov Identifier: NCT05697471
• Other Study ID Numbers: 111207-F
• First Posted: Jan 26, 2023
• Last Update Posted: Jan 26, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Endometriosis; Dienogest; Danazol

Study Results

No Results Posted as of Jan 26, 2023