- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01218581
Aromatase Inhibitors or GnRH-a for Uterine Adenomyosis
Aromatase Inhibitors or Gonadotropin-releasing Hormone Agonists for the Management of Uterine Adenomyosis: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Dakahlia
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Mansoura, Dakahlia, Egypt, 35111
- Mansoura University Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Uterine Diseases
- Adenomyosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Letrozole
- Goserelin
Other Study ID Numbers
- ADENOMYOSIS
- aromatase inhibitors
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