ANZCTR - Registration

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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]

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

New health condition. Please modify.

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

Pap smear quality - defined as number of atrophic smears and number of smears with endocervical material absent according to established cytological criteria.

Timepoint [1]

at conclusion of recruitment all smears will be reread by a "blinded" single cytologist

Secondary outcome [1]

Subjective comfort level of pap smear procedure relative to previous smears using a Likert Scale at the conclusion of the smear.

Timepoint [1]

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]

Other

Name [1]

Family Planning NSW

Address [1]

family planning NSW
328-336 Liverpool Rd
Ashfield NSW 2131

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Family Planning NSW

Address [2]

family planning NSW
328-336 Liverpool Rd
Ashfield NSW 2131

Country [2]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Family Planning NSW

Address

328-336 Liverpool Rd Ashfield 2131

Country

Australia

Secondary sponsor category [1]

None

Name [1]

nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Family Planning NSW Ethics Committee

Ethics committee address [1]

328-336 Liverpool Rd
Ashfield NSW

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/10/2003

Approval date [1]

21/11/2003

Ethics approval number [1]

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

Dr Deborah Bateson

Address

328-.336 Liverspool Road
Ashfield 2131

Country

Australia

Phone

+61 2 8752 4341

Fax

deborah@fpnsw.org.au

Contact person for public queries

Name

Dr Deborah Bateson

Address

Sydney Centre for Reproductive Health Research
FPA Health
328 - 336 Liverpool Road
Ashfield NSW 2131

Country

Australia

Phone

+61 2 87524344

Fax

deborahb@fpnsw.orag.au

Contact person for scientific queries

Name

Dr Deborah Bateson

Address

Sydney Centre for Reproductive Health Research
FPA Health
328 - 336 Liverpool Road
Ashfield NSW 2131

Country

Australia

Phone

+61 2 87524344

Fax

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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