Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis

Assiut University

Status and phase: Unknown; Phase 4

Conditions: Adenomyosis

Treatments: Drug: Dienogest; Drug: Combined Oral Contraceptive

Study type: Interventional

Funder types: Other

Identifiers

NCT03654144

DINADEN

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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 )

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Study group

Experimental group

Description:

women will receive dienogest

Treatment:

Drug: Dienogest

control group

Active Comparator group

Description:

women used combined oral contraceptive pills

Treatment:

Drug: Combined Oral Contraceptive