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Aromatase Inhibitors or GnRH-a for Uterine Adenomyosis

NCT01218581 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2010-10-11

No results posted yet for this study

Summary

To date, there is no uniform agreement on the most appropriate therapeutic methods for managing women with uterine adenomyosis and/or adenomyoma who want to preserve their fertility. Management with hormonal treatment that aims to reduce the proliferation of endometrial cells is promising, but there is a paucity of well-designed studies to guide treatment. There is a strong need to develop pharmacological agents that provide an efficient outcome. Gonadotripn releasing hormone analogues (GnRHa) have been used in several studies, to produce a constant hypoestrogenic state in a woman with adenomyosis which cause amenorrhoea, control of pain and uterine shrinkage . Pure antiestrogens, however, may offer some advantage in the treatment of adenomyosis and trials are required to assess its usefulness. Leiomyoma and uterine volumes were successfully reduced by use of aromatase inhibitors (AIs). Assuming aromatase production activity in the adenomyosis lesion, Kimura et al, used GnRHa and an AI concomitantly for treatment of uterine adenomyosis. This lack of information stimulated us to run this trial to compare the efficacy of aromatase inhibitor vs. GnRHa in treating premenopausal women with uterine adenomyosis.

Conditions

  • the Efficacy of Aromatase Inhibitor vs. Gonadotrpins Releasing Hormone Agonists in Treating Premenopausal Women With Uterine Adenomyosis

Interventions

DRUG

received oral letrozole (2.5 mg/day)and goserelin subcutaneosly (3.6 mg/month)

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Egypt

Study Locations

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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 NCT01218581 on ClinicalTrials.gov