Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis

Phase 4

• Conditions: Adenomyosis
• Interventions: Drug: Combined Oral Contraceptive; Drug: Dienogest

• Registration Number: NCT03654144
• Lead Sponsor: Assiut University

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-08-29
• Last Update Submitted: 2018-08-29
• Study First Posted: 2018-08-31
• Last Update Posted: 2018-08-31
• Study Start: 2018-11
• Primary Completion: 2019-12
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 )

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Combined Oral Contraceptive	women used combined oral contraceptive pills
Study group	Dienogest	women will receive dienogest

Primary Outcome Measures

Name	Time	Method
The mean pain score after receiving treatment	6 months	assessment by visual analog scale