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Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy

NCT00888082 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2010-12-10

No results posted yet for this study

Summary

Primary objective of this study is to determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses via menstrual history, serum FSH and E2 measurements.

The secondary objectives of this study are as follows: To investigate the impact of treatment with chemotherapy with or without goserelin acetate (i.e. impact of the expectation of ovarian function preservation) on participants' quality of life (QOL) by FACT-ES scale, and to compare safety and tolerability of study drugs in two treatment groups by evaluation of adverse events.

Conditions

Interventions

DRUG

Goserelin acetate

3.6 mg depot injectable preparation

Sponsors & Collaborators

Principal Investigators

  • Mustafa Özgüroğlu, Assoc.Prof. · Istanbul University Cerrahpasa Medical Faculty, Medical Oncology Clinic, Cerrahpasa 34098, Istanbul, Turkey

  • Yeşim Eralp, Assoc.Prof. · Istanbul University Istanbul Medical Faculty, Oncology Institute, Medical Oncology Department, Capa 34360 Istanbul, Turkey

  • Gül Başaran, Assoc.Prof. · Marmara University Medical Faculty, Medical Oncology Department, Istanbul, Turkey

  • Kadri Altundağ, Prof. · Hacettepe University Medical Faculty, Medical Oncology Department, Sihhiye 06100 Ankara, Turkey

  • Filiz Çay Şenler, Assoc.Prof. · Ankara University Medical Faculty, Medical Oncology Department, Sihhiye 06100 Ankara, Turkey

  • Metin Özkan · Erciyes University Medical Faculty, Medical Oncology Department, 38039 Kayseri, Turkey

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Turkey (Türkiye)

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00888082 on ClinicalTrials.gov