NCT00761683

Brief Summary

To observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for symptoms: dysmenorrhoea, dyspareunia and pelvic pain; to observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for pelvic tenderness and indurations; to observe the reduction in the proportion of patients requiring analgesics for the relief of pelvic pain for 6 months in patients treated with Zoladex 3.6 mg.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

September 26, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
Last Updated

September 10, 2009

Status Verified

September 1, 2009

First QC Date

September 26, 2008

Last Update Submit

September 8, 2009

Conditions

Endometriosis

Keywords

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • Biberoglu and Bergham Scale

    monthly/ at every clinic visit- 6 times for symptoms: dysmenorrhoea, dyspareunia and pelvic pain

Secondary Outcomes (1)

  • Biberoglu and Bergham Scale

    twice/first and last clinic visit for pelvic tenderness and indurations

Study Arms (1)

1

Patients diagnosed with endometriosis

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The programme will include the patients diagnosed with endometriosis that the doctors have already decided to treat with Zoladex within the last month, before inclusion in this program.

You may not qualify if:

  • patients who have a known hypersensitivity to goserelin (Zoladex) or any of its excipients or any other GnRH analogue, pregnancy, according to Romanian approved goserelin 3,6 mg SmPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Bucharest, Romania

Location

Research Site

Cluj-Napoca, Romania

Location

Research Site

Timișoara, Romania

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Cristina Pentiuc

    AstraZeneca Romania

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 29, 2008

Study Start

October 1, 2008

Last Updated

September 10, 2009

Record last verified: 2009-09

Locations

RO(3)