Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000119099
Ethics application status
Approved
Date submitted
27/01/2010
Date registered
4/02/2010
Date last updated
4/02/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Study for the assessment of clinical non-inferiority and tolerability of Estrogenon (Sanval Comercio e Industria Ltda) in comparasion to Premarin (Wyeth Industria Farmaceutica Ltda) in women post menopause.
Scientific title
Study for the assessment of clinical non-inferiority and tolerability of Estrogenon drug – conjugated estrogens, coated tablets coated tablet manufactured by Sanval Comercio e Industria Ltda. in comparison to (PREMARIN) coated tablets manufactured by Wyeth Industria Farmaceutica Ltda. in women post menopause
Secondary ID [1] 1350 0
None
Universal Trial Number (UTN)
U1111-1113-4072
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Study with the purpose of check clinical non- inferiority and tolerance of conjugated estrogen coated tablet manufactured by different manufactures 256682 0
Women in post menopause with indications for estrogens replacement therapy. 256718 0
Condition category
Condition code
Reproductive Health and Childbirth 256838 256838 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Estrogen drug - conjugated estrogens, coated tablets 0,625mg/coated tablet manufactured by Sanval Comercio e Industria Ltda,taken orally once a day for a total of 90 days, in comparasion to Premarin 0,625 mg/coated tablet manufactured by Wyeth Industria Farmaceutica Ltda, taken orally once a day also for a total of 90 days.
Intervention code [1] 255911 0
Treatment: Drugs
Comparator / control treatment
Comparison of action of two differents coated tablet of conjugated estrogens 0625mg/coated tablet, taken orally once a day, during 90 days on a clinical setting.
Control group
Active

Outcomes
Primary outcome [1] 257706 0
Endometium thickness; alterations in clinical examination (gynecological)
Timepoint [1] 257706 0
at 90 days from baseline.
Secondary outcome [1] 263052 0
Nil
Timepoint [1] 263052 0
Nil

Eligibility
Key inclusion criteria
Women in menopause with indications for estrogen replacement therapy.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with contraindications for estrogen use.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment outside Australia
Country [1] 2418 0
Brazil
State/province [1] 2418 0
Minas Gerais

Funding & Sponsors
Funding source category [1] 256443 0
Commercial sector/Industry
Name [1] 256443 0
Sanval Comercio e Industria Ltda
Country [1] 256443 0
Brazil
Primary sponsor type
Commercial sector/Industry
Name
Sanval Comercio e Industria Ltda
Address
Rua Lagrange 401 - Socorro - Sao Paulo - Brazil - 04761-050
Country
Brazil
Secondary sponsor category [1] 255743 0
None
Name [1] 255743 0
Address [1] 255743 0
Country [1] 255743 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258465 0
Comite de Etica em Pesquisa do Hospital Belo Horizonte
Ethics committee address [1] 258465 0
Ethics committee country [1] 258465 0
Brazil
Date submitted for ethics approval [1] 258465 0
Approval date [1] 258465 0
09/03/2009
Ethics approval number [1] 258465 0

Summary
Brief summary
Patients at post-menopause phase, after signing Free and Informed Consent Term, shall pass through medical consultation and laboratorial exams (clinical analysis) including plasmatic dosing of Follicle-stimulating hormone (FSH), Luteinizing hormone (LH), Glutamate Oxaloacetate Transaminase (GOT) and glutamic-pyruvic transaminase (GPT), calcium and Total Estrogen (Estradiol) and Free Estrogen (Free Estriol), Glucose and total Cholesterol. A mammography will be performed in order to exclude patients with counter indication for the drug use. Patients shall be sent to undergo transvaginal ultrasound exam in order to assess their endometrium thickness. During medical consultation, vaginal walls as well as the cervix will be scraped for functional cytological and oncologic exam, using Papanicolaou test method. The procedures, in total or in part, shall be repeated at the following visits, within three months follow-up time period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30728 0
Address 30728 0
Country 30728 0
Phone 30728 0
Fax 30728 0
Email 30728 0
Contact person for public queries
Name 13975 0
Jose Aurelio Quintao Sarmento
Address 13975 0
Av. Nicolau Alayon 441, Interlagos, Sao Paulo - 04802-000
Country 13975 0
Brazil
Phone 13975 0
+551156604001
Fax 13975 0
+551156668664
Email 13975 0
aurelio.sarmento@sanval.com.br
Contact person for scientific queries
Name 4903 0
Dr. Marco Tulio Bacarrini Pires PhD
Address 4903 0
Av. do contorno 2646 - 6º andar - Belo Horizonte - Minas Gerais - 30110-014
Country 4903 0
Brazil
Phone 4903 0
+553132483458
Fax 4903 0
+553132483458
Email 4903 0
mtbpires@cebio.med.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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