Role of Dienogest in the Treatment of Patient With Sympto... | NCT03654144

Studies
Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis

NCT03654144

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Aug 31, 2018Actual

Enrollment

100Estimated

Phase

Phase 4

Conditions

Adenomyosis

Interventions

Dienogest
Combined Oral Contraceptive

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2018Estimated

Primary Completion Date

Dec 2019Estimated

Completion Date

Mar 2020Estimated

First Submitted Date

Aug 29, 2018

First Submission Date that Met QC Criteria

Aug 29, 2018

First Posted Date

Aug 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2018

Last Update Posted Date

Aug 31, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	women will receive dienogest	Drug: Dienogest
control group	Active Comparator	women used combined oral contraceptive pills	Drug: Combined Oral Contraceptive

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dienogest	Drug	oral tablets	Study group
Combined Oral Contraceptive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The mean pain score after receiving treatment	assessment by visual analog scale	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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 )

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D062788	Adenomyosis

Ancestor Terms

ID	Term
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C023635	dienogest
D003277	Contraceptives, Oral, Combined

Ancestor Terms

ID	Term
D004338	Drug Combinations
D004364	Pharmaceutical Preparations
D003276	Contraceptives, Oral
D003271	Contraceptive Agents, Female

Browse Leaves

Not provided

Browse Branches

Not provided