NCT03654144

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

August 29, 2018

Last Update Submit

August 29, 2018

Conditions

Adenomyosis

Outcome Measures

Primary Outcomes (1)

  • The mean pain score after receiving treatment

    assessment by visual analog scale

    6 months

Study Arms (2)

Study group

EXPERIMENTAL

women will receive dienogest

Drug: Dienogest

control group

ACTIVE COMPARATOR

women used combined oral contraceptive pills

Drug: Combined Oral Contraceptive

Interventions

DienogestDRUG

oral tablets

Study group
Combined Oral ContraceptiveDRUG

oral tablets

control group

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptomatic adenomyosis
  • irregular menstrual bleeding and dysmenorrhea .

You may not qualify if:

  • 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 )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Adenomyosis

Interventions

dienogestContraceptives, Oral, Combined

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Drug CombinationsPharmaceutical PreparationsContraceptives, OralContraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 29, 2018

First Posted

August 31, 2018

Study Start

November 1, 2018

Primary Completion

December 1, 2019

Study Completion

March 1, 2020

Last Updated

August 31, 2018

Record last verified: 2018-08