Aromatase Inhibitors or GnRH-a for Uterine Adenomyosis

October 8, 2010 updated by: Mansoura University

Aromatase Inhibitors or Gonadotropin-releasing Hormone Agonists for the Management of Uterine Adenomyosis: A Randomized Controlled Trial

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.

Study Overview

Detailed Description

This is a prospective, randomized, non-blind trial performed in the period from December 2005 and January 2010 in the teaching hospitals affiliated with Mansoura University (Egypt) and a private practice setting (Delta Fertility Center, Egypt). Thirty eight patients were assessed for eligibility, 6 patients were excluded and 32 with uterine adenomyosis were included in the study. Patients included in the study were premenopausal women aged 18-42 years with adenomyosis with abnormal uterine bleeding, unexplained infertility, pelvic pain, dysmenorrhea, or pressure effect. Excluded subjects included women who had myoma(s) measuring >2 cm, women with uterine adenomyoma who were under treatment with any type of hormonal therapy more recently than 1 month, and women with a history of major medical problem and/or previous medical or surgical treatment for the problem.

Patients were randomly allocated into two treatments groups (A and B) using a computer-generated random table. Group A received oral letrozole (2.5 mg/day, Femara, Novartis PharmaServices, Basel, Switzerland) and group B received goserelin subcutaneosly (3.6 mg/month, Zoladex@, Zeneka Pharma International, UK) for 12 weeks. Because, for technical reasons, GnRHa was supplied in vials and aromatase inhibitor in tablets, a double-blind study design was not feasible. Instead an assessor-blind design was chosen, whereby preparation and administration were performed by a person who did not take part in any decision concerning medication administration during the study. The study was approved by the ethics committee of the university and institutional Review Board (IRB), and each subject provided written informed consent before participating in the study. All subjects underwent baseline measurement, performed in the early follicular phase.

An expert gynecologist performed all transvaginal ultrasound scans and analysis using D 4000 (Honda, Japan) ultrasound machine with a 5.5-MHz vaginal probe. Ultrasound criteria used for diagnosis of adenomyosis included uterine enlargement in the absence of leiomyomas, asymmetric enlargement of the anterior or posterior myometrial wall, lack of contour abnormality or mass effect, heterogeneous, poorly circumcised areas within the myometrium, hyperechoic islands or nodules, finger-like projections or linear striations. After identification of the adenomyosis, its volume was calculated with a stepwise planimetry method using an integrated software program. Measurements for the whole uterine and the adenomyoma volumes were performed at baseline and during treatment at weeks 4, 8, and 12. Symptoms at the start and after 12 weeks of therapy were evaluated.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35111
        • Mansoura University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients included in the study were premenopausal women aged 18-42 years with adenomyosis with abnormal uterine bleeding, unexplained infertility, pelvic pain, dysmenorrhea, or pressure effect

Exclusion Criteria:

  • Excluded subjects included women who had myoma(s) measuring >2 cm, women with uterine adenomyoma who were under treatment with any type of hormonal therapy more recently than 1 month, and women with a history of major medical problem and/or previous medical or surgical treatment for the problem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A
Group A received oral letrozole (2.5 mg/day, Femara, Novartis PharmaServices, Basel, Switzerland)
Active Comparator: group B
group B received goserelin subcutaneosly (3.6 mg/month, Zoladex@, Zeneka Pharma International, UK)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

October 8, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (Estimate)

October 11, 2010

Study Record Updates

Last Update Posted (Estimate)

October 11, 2010

Last Update Submitted That Met QC Criteria

October 8, 2010

Last Verified

December 1, 2005

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

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