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Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis

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ClinicalTrials.gov Identifier: NCT03654144
Recruitment Status : Not yet recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
asmaa mohamed hussin yousef, 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

Condition or disease Intervention/treatment Phase
Adenomyosis Drug: Dienogest Drug: Combined Oral Contraceptive Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dienogest

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




Primary Outcome Measures :
  1. The mean pain score after receiving treatment [ Time Frame: 6 months ]
    assessment by visual analog scale



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 )

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Responsible Party: asmaa mohamed hussin yousef, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03654144     History of Changes
Other Study ID Numbers: DINADEN
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenomyosis
Anabolic Agents
Uterine Diseases
Genital Diseases, Female
Dienogest
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Nandrolone
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents, Male
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgens
Hormones