NCT00123175

Brief Summary

The purpose of this research is to determine the effectiveness of the intrauterine device (IUD) called Mirena when compared to the Provera tablets used in treating this condition.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2009

Typical duration for phase_1

Status
withdrawn

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

July 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
4.1 years until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

2 years

First QC Date

July 20, 2005

Last Update Submit

January 7, 2013

Conditions

Endometrial Hyperplasia

Keywords

Endometrial Hyperplasia without atypia

Outcome Measures

Primary Outcomes (1)

  • Pathologic examination of the specimens obtained by endometrial biopsy to determine the regression of endometrial hyperplasia without atypia compared to Provera

    90 days

Secondary Outcomes (3)

  • Side effects

    90 days

  • Bleeding profile

    90 days

  • Estradiol and progesterone levels

    90 days

Interventions

Intrauterine DeviceDEVICE

Mirena and Provera

Also known as: Medroxyprogesterone Acetate and Progestins

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic diagnosis of simple or complex endometrial hyperplasia without atypia
  • Normal pap smear within one year

You may not qualify if:

  • Diabetes
  • Family history of endometrial cancer
  • Contraindications for the intrauterine device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Endometrial Hyperplasia

Interventions

Intrauterine Devices

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Contraceptive Devices, FemaleContraceptive DevicesEquipment and Supplies

Study Officials

  • Richard Legro, M.D.

    Penn State University College of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Obstetrics and Gynecology and Public Health Sciences

Study Record Dates

First Submitted

July 20, 2005

First Posted

July 22, 2005

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 8, 2013

Record last verified: 2013-01