Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000103066
Ethics application status
Approved
Date submitted
27/01/2010
Date registered
2/02/2010
Date last updated
2/02/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Study for the assessment of clinical non-inferiority and tolerability of different conjugated estrogen vaginal cream ESTROGENON (Sanval Comercio e Industria Ltda) versus PREMARIN (Wyeth Industria Farmaceutica Ltda) in women post menopause.
Scientific title
Study for the assessment of clinical non-inferiority and tolerability of different conjugated estrogen vaginal cream ESTROGENON (Sanval Comercio e Industria Ltda) versus PREMARIN (Wyeth Industria Farmaceutica Ltda) in women post menopause.
Secondary ID [1] 1352 0
Nil
Universal Trial Number (UTN)
U1111-1113-4033
Trial acronym
CEBIO_11_2008
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Study with the purpose of check clinical non-inferiority and tolerance of two vaginal cream based on the conjugated estrogen manufactured by different manufacturers. 256600 0
Women in post menopause with indications for estrogen replacement therapy. 256719 0
Condition category
Condition code
Reproductive Health and Childbirth 256765 256765 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Estrogenon (conjugated estrogens), vaginal cream 0,625mg/g manufactured by Sanval Comercio e Industria Ltda,administered once a each two days for a total of 90 days, applied with cream disposable applicator, in comparasion to Premarin(Estrogen conjugated) 0,625 mg/g manufactured by Wyeth Industria Farmaceutica Ltda, taken once the each two days for a total of 90 days, administrated by cream disposable applicator.
Intervention code [1] 255859 0
Not applicable
Comparator / control treatment
Comparison of action of two differents vaginal cream of conjugated estrogens 0625mg/g, taken once the each two days, during 90 days on a clinical setting and administrated by cream disposable applicator.
Control group
Active

Outcomes
Primary outcome [1] 257752 0
Endometrium thickness - test used: transvaginal ultrasound exam
Timepoint [1] 257752 0
90 days following randomization
Secondary outcome [1] 263126 0
Alterations in clinical examination (gynecological) - Citology
Timepoint [1] 263126 0
90 days following randomization

Eligibility
Key inclusion criteria
Women in post 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] 2417 0
Brazil
State/province [1] 2417 0

Funding & Sponsors
Funding source category [1] 256351 0
Commercial sector/Industry
Name [1] 256351 0
Sanval Comercio e Industria Ltda.
Country [1] 256351 0
Brazil
Primary sponsor type
Commercial sector/Industry
Name
Sanval Comercio e Industria Ltda.
Address
R. Lagrange, 401 _ Bairro Socorro
Sao Paulo - Brazil - 04802-000
Country
Brazil
Secondary sponsor category [1] 251665 0
None
Name [1] 251665 0
Address [1] 251665 0
Country [1] 251665 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258467 0
Comite de Etica em Pesquisa do Hospital Belo Horizonte
Ethics committee address [1] 258467 0
Ethics committee country [1] 258467 0
Brazil
Date submitted for ethics approval [1] 258467 0
Approval date [1] 258467 0
09/03/2009
Ethics approval number [1] 258467 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 30725 0
Address 30725 0
Country 30725 0
Phone 30725 0
Fax 30725 0
Email 30725 0
Contact person for public queries
Name 13972 0
Jose Aurelio Quintao Sarmento
Address 13972 0
Av. Nicolau Alayon 441 - Interlagos - Sao Paulo - Sao Paulo -04802-000
Country 13972 0
Brazil
Phone 13972 0
+551156604001
Fax 13972 0
+551156668664
Email 13972 0
aurelio.sarmento@sanval.com.br
Contact person for scientific queries
Name 4900 0
Dr. Marco Tulio Baccarini Pires PhD
Address 4900 0
Av. Contorno 2646 - 6º andar - Belo Horizonte - Minas Gerais - 30110-014
Country 4900 0
Brazil
Phone 4900 0
+553132413458
Fax 4900 0
+553132413458
Email 4900 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
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