Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis

• Sponsor: Assiut University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03654144
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 16

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Adenomyosis	Drug: Dienogest; Drug: Combined Oral Contraceptive	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis
• Anticipated Study Start Date: Nov 1, 2018
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group women will receive dienogest	Drug: Dienogest; oral tablets
Active Comparator: control group women used combined oral contraceptive pills	Drug: Combined Oral Contraceptive; oral tablets

Outcome Measures

Primary Outcome Measures

1. The mean pain score after receiving treatment [6 months]

   assessment by visual analog scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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 )

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: asmaa mohamed hussin yousef, Principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03654144
• Other Study ID Numbers: DINADEN
• First Posted: Aug 31, 2018
• Last Update Posted: Aug 31, 2018
• Last Verified: Aug 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Adenomyosis; Dienogest; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined

Study Results

No Results Posted as of Aug 31, 2018