NCT00286351

Brief Summary

Does a combination of Arimidex and Zoladex make endometriomas shrink and how is the following IVF outcome

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

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

January 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2006

Completed
Last Updated

April 23, 2007

Status Verified

April 1, 2007

First QC Date

February 1, 2006

Last Update Submit

April 20, 2007

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • size of endometriomas after 2½ month of combined downregulation

Interventions

Combined treatment with Arimidex and Zoladex before IVFDRUG

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Endometrioma(s)with a size of 20-70 mm, persisted for at least 3 cycles
  • Couples with indication and wish for IVF/ICSI
  • Age of women: 20-40 years
  • Regular menstrual cycle within normal range (21-35 days)
  • Body Mass Index (BMI): 18-30 kg/m2

You may not qualify if:

  • History with osteoporosis, liver-, kidney- or heart disease or thromboembolic disease
  • Treatment of endometriosis with GnRH agonist during the last 3 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet

Copenhagen, Copenhagen East, 2100, Denmark

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Combined Modality TherapyAnastrozole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TherapeuticsNitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kristine Lossl, medical doctor

    The Fertility Clinic, Copenhagen University Hospital Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 3, 2006

Study Start

January 1, 2005

Last Updated

April 23, 2007

Record last verified: 2007-04

Locations

DK(1)