Comparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis

NCT05697471 — Phase 3, Unknown, 120 participants, Far Eastern Memorial Hospital

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Far Eastern Memorial Hospital

RegistryNCT05697471
StatusUnknown
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment120 (Estimated)
SponsorFar Eastern Memorial Hospital (Other)
ConditionsEndometriosis
InterventionsDienogest, Danazol (Drug)
Datesstart 2023-02-25, primary completion 2025-12-31 (estimated), completion 2025-12-31 (estimated), first posted 2023-01-26, last updated 2023-03-29
Locations1 site in Taiwan

Related Papers Related Patents Related Grants Related Experts
All trials for Endometriosis All trials of Dienogest All trials of Danazol

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
DienogestExperimentalDrug: Dienogest
DanazolActive comparatorDrug: Danazol
  • Dienogest (Drug): Dienogest 2 mg per day
  • Danazol (Drug): Danzol 200MG per day

+Outcome measures

Primary outcomes

  • The change of severity in dysmenorrhea [16 weeks]: Between-group difference in the score of global response assessment of dysmenorrhea

Secondary outcomes

  • 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

+Eligibility

Sex: Female, ages: 20 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Department of Obstetrics and Gynecology, Far Eastern Memorial HospitalBanqiao District, New TaipeiTaiwanRecruiting