Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis

Adenomyosis Clinical Trial

Official title:

Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03654144
• Other study ID #: DINADEN
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 2018
• Est. completion date: March 2020

Study information

• Verified date: August 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adenomyosis was first described as endometrial glands in the myometrium of the uterus. The current definition of adenomyosis is provided in 1972 'the benign invasion of endometrium into the myometrium, producing a diffusely enlarged uterus which microscopically exhibits ectopic non-neoplastic, endometrial glands and stroma surrounded by the hypertrophic and hyperplastic myometrium

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• symptomatic adenomyosis

• irregular menstrual bleeding and dysmenorrhea .

Exclusion Criteria:

• asymptomatic patients -

• non-lactating patient

• not desire for pregnancy

• no hormonal treatment more than 6 month even contraception e.g IUD

• no focal lesion of uterus (malignancy ,fibroid or adenxal mass )

Related Conditions & MeSH terms

• Adenomyosis

Intervention

Drug:
• Dienogest
oral tablets
• Combined Oral Contraceptive
oral tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean pain score after receiving treatment	assessment by visual analog scale	6 months