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Aromatase Inhibitors or GnRH-a for Uterine Adenomyosis

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
received oral letrozole (2.5 mg/day)and goserelin subcutaneosly (3.6 mg/month)
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for the Efficacy of Aromatase Inhibitor vs. Gonadotrpins Releasing Hormone Agonists in Treating Premenopausal Women With Uterine Adenomyosis focused on measuring Adenomyosis, letrozole, GnRH-a

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mansoura University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group A

group B

Arm Description

Group A received oral letrozole (2.5 mg/day, Femara, Novartis PharmaServices, Basel, Switzerland)

group B received goserelin subcutaneosly (3.6 mg/month, Zoladex@, Zeneka Pharma International, UK)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 8, 2010
Last Updated
October 8, 2010
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT01218581
Brief Title
Aromatase Inhibitors or GnRH-a for Uterine Adenomyosis
Official Title
Aromatase Inhibitors or Gonadotropin-releasing Hormone Agonists for the Management of Uterine Adenomyosis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
the Efficacy of Aromatase Inhibitor vs. Gonadotrpins Releasing Hormone Agonists in Treating Premenopausal Women With Uterine Adenomyosis
Keywords
Adenomyosis, letrozole, GnRH-a

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Active Comparator
Arm Description
Group A received oral letrozole (2.5 mg/day, Femara, Novartis PharmaServices, Basel, Switzerland)
Arm Title
group B
Arm Type
Active Comparator
Arm Description
group B received goserelin subcutaneosly (3.6 mg/month, Zoladex@, Zeneka Pharma International, UK)
Intervention Type
Drug
Intervention Name(s)
received oral letrozole (2.5 mg/day)and goserelin subcutaneosly (3.6 mg/month)

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mansoura University Hospitals
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35111
Country
Egypt

12. IPD Sharing Statement

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Aromatase Inhibitors or GnRH-a for Uterine Adenomyosis

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