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.
Terminated
- Conditions
- Quality of post-menopausal pap smearsNew health condition. Please modify.Reproductive Health and Childbirth - Menstruation and menopause
- Registration Number
- ACTRN12605000610639
- Lead Sponsor
- Family Planning NSW
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- Female
- Target Recruitment
- 270
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pap smear quality - defined as number of atrophic smears and number of smears with endocervical material absent according to established cytological criteria.[at conclusion of recruitment all smears will be reread by a blinded single cytologist]
- Secondary Outcome Measures
Name Time Method Subjective comfort level of pap smear procedure relative to previous smears using a Likert Scale at the conclusion of the smear.[documented at completion of smear]