Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000610639
Ethics application status
Approved
Date submitted
5/10/2005
Date registered
6/10/2005
Date last updated
23/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A single-blinded randomised controlled trial to evaluate the pre-treatment effect of two vaginal estradiol doses compared to no treatment on the quality of pap smears in post-menopausal women.
Scientific title
A single-blinded randomised controlled trial to evaluate the pre-treatment effect of two vaginal estradiol doses compared to no treatment on the quality of pap smears in post-menopausal women.
Secondary ID [1] 528 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of post-menopausal pap smears 741 0
New health condition. Please modify. 2904 0
Condition category
Condition code
Reproductive Health and Childbirth 817 817 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Post-menopausal women presenting to two FPA Health centres for routine pap smears to be randomly assigned to a) Group 1: one tablet of estradiol to be inserted into the vagina 3 nights prior to the pap smear; b) Group 2: five tablets of estradiol to be inserted into the vagina on consecutive nights one week prior to the pap smear
Intervention code [1] 698 0
Treatment: Drugs
Comparator / control treatment
c) Control Group - no estradiol to be used prior to the pap smear.
Control group
Dose comparison

Outcomes
Primary outcome [1] 1050 0
Pap smear quality - defined as number of atrophic smears and number of smears with endocervical material absent according to established cytological criteria.
Timepoint [1] 1050 0
at conclusion of recruitment all smears will be reread by a "blinded" single cytologist
Secondary outcome [1] 1953 0
Subjective comfort level of pap smear procedure relative to previous smears using a Likert Scale at the conclusion of the smear.
Timepoint [1] 1953 0
documented at completion of smear

Eligibility
Key inclusion criteria
Naturally menopausal women with no spontaneous menses for the past 12 months; surgically menopausal women aged 20 - 70 years at least 12 months post-menopause; women in general good health who require a pap smear according to current guidelines; women who are able to consent and provide contact details.
Minimum age
40 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Use of systemic or vaginal hormone replacement therapy (including Tibolone) within the past 3 months; undiagnosed vaginal bleeding; previous cone biopsy of the cervix; known hypersensitivity or allergy to consituents of vaginal tablet; inability to insert applicator; women requesting liquid-based cytology.

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)
A set of random numbers will be used to create a sequence contained in opaque envelopes for use by the researcher. As participants are recruited, the next envelope in the sequence is opened and the participant will be assigned to the stated group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjetcs will be block randomised using a computer generated set of random numbers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/11/2005
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
30/05/2008
Date of last data collection
Anticipated
Actual
1/08/2008
Sample size
Target
270
Accrual to date
Final
164
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 906 0
Other
Name [1] 906 0
Family Planning NSW
Country [1] 906 0
Australia
Funding source category [2] 3157 0
Charities/Societies/Foundations
Name [2] 3157 0
Family Planning NSW
Country [2] 3157 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Family Planning NSW
Address
328-336 Liverpool Rd Ashfield 2131
Country
Australia
Secondary sponsor category [1] 765 0
None
Name [1] 765 0
nil
Address [1] 765 0
Country [1] 765 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296742 0
Family Planning NSW Ethics Committee
Ethics committee address [1] 296742 0
328-336 Liverpool Rd
Ashfield NSW
Ethics committee country [1] 296742 0
Australia
Date submitted for ethics approval [1] 296742 0
02/10/2003
Approval date [1] 296742 0
21/11/2003
Ethics approval number [1] 296742 0
R2003/7

Summary
Brief summary
OBJECTIVE:
Atrophic Papanicolaou (Pap) smears from postmenopausal women may be unsatisfactory for assessment or result in a false-positive diagnosis of a cytological abnormality. We investigated the effect of vaginal estrogen treatment before the Pap test on the odds of an atrophic smear.
METHODS:
An open-label randomized controlled trial was conducted to compare the proportion of atrophic Pap smears from postmenopausal women assigned to either (1) a regimen of one 25-microg vaginal estradiol tablet inserted nightly for five nights before their Pap test, (2) a single 25-microg vaginal estradiol tablet before the test, or (3) a control group with no previous estrogen administration. All smears were reread and classified as atrophic or nonatrophic at the conclusion of the study by a single cytopathologist who was blinded to the study arms.
RESULTS:
One hundred fifty-four (94%) of the 164 postmenopausal women who consented to the study were included in the final analysis. Fifty-one women had received the five-night course of tablets, 50 had received one tablet, and 53 were assigned to the group with no previous estrogen use. The odds of an atrophic smear were significantly lower in women who used the five-night estrogen regimen than in women who did not use estrogen. The estimated odds ratio of an atrophic smear in the five-night regimen was 0.01 (95% CI, 0.03-0.26) compared with the no-estrogen control group. Moreover, using one tablet of estrogen had no significant effect on the likelihood of an atrophic smear compared with using none. The odds ratio of an atrophic smear in the single estrogen tablet group was 1.05 (95% CI, 0.48-2.29) compared with the no-estrogen group.
CONCLUSIONS:
The odds of an atrophic smear are significantly reduced for postmenopausal women who use a five-night regimen of vaginal estrogen before their Pap test.
Trial website
Trial related presentations / publications
Bateson DJ, Weisberg E. An open-label randomized trial to determine the most effective regimen of vaginal estrogen to reduce the prevalence of atrophic changes reported in postmenopausal cervical smears. Menopause 2009; 16(4): 765-9.
Public notes

Contacts
Principal investigator
Name 35920 0
Dr Deborah Bateson
Address 35920 0
328-.336 Liverspool Road
Ashfield 2131
Country 35920 0
Australia
Phone 35920 0
+61 2 8752 4341
Fax 35920 0
Email 35920 0
deborah@fpnsw.org.au
Contact person for public queries
Name 9887 0
Dr Dr Deborah Bateson
Address 9887 0
Sydney Centre for Reproductive Health Research
FPA Health
328 - 336 Liverpool Road
Ashfield NSW 2131
Country 9887 0
Australia
Phone 9887 0
+61 2 87524344
Fax 9887 0
Email 9887 0
deborahb@fpnsw.orag.au
Contact person for scientific queries
Name 815 0
Dr Dr Deborah Bateson
Address 815 0
Sydney Centre for Reproductive Health Research
FPA Health
328 - 336 Liverpool Road
Ashfield NSW 2131
Country 815 0
Australia
Phone 815 0
+61 2 87524344
Fax 815 0
Email 815 0
deborahb@fpnsw.org.au

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

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