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.

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000610639

Enrollment

164

Registered

2005-10-06

Start date

2005-11-01

Completion date

2008-05-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

40 Years to 70 Years

Healthy volunteers

Yes

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.

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.

Outcome results