NCT02894151

Brief Summary

The primary objective : To compare effectiveness of pain control in endometriosis associated pelvic pain between LNG-IUS and DMPA The secondary objective : To compare vaginal bleeding pattern, side effect, continuation rate, satisfaction and quality of life between LNG-IUS and DMPA in treatment of endometriosis associated pelvic pain

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_2

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

1.1 years

First QC Date

August 31, 2016

Last Update Submit

September 3, 2016

Conditions

Clinically Diagnosed Endometriotic Patient Was Defined as a Woman Who Has Pelvic Pain and at Least One Evidence of PV or TVS

Outcome Measures

Primary Outcomes (1)

  • Change baseline pain score assessed by visual analog scale after 6 month-use of both interventions

    1year

Study Arms (2)

LNG-IUS

ACTIVE COMPARATOR

LNG IUS was hormonal containing IUD relased LNG at constant rate through out 5 year period. It was inserted only first time entry in the study.

Device: LNG-IUS

DMPA

ACTIVE COMPARATOR

DMPA was given in trimonthly intramuscular injection.

Drug: Depot medroxyprogesterone acetate

Interventions

Depot medroxyprogesterone acetateDRUG
DMPA
LNG-IUSDEVICE
LNG-IUS

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-45year Pelvic pain VAS\>50 Previous Sexual intercouse

You may not qualify if:

  • other genital tract disease causing pelvic pain Previous hromonal treament 3 month History of DMPA treatment failure WHO eligibility criteria 2009 categorized in 3-4 for DMPA and LNG-IUS user Fertility desire within 1 year Psychoneurosis Pregnant and breast fed women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 9, 2016

Study Start

April 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 9, 2016

Record last verified: 2016-09