Effects of Testosterone and Oestradiol Therapy on Clinical Indices and Biomarkers of Dry Eye in Post Menopausal Women

In post menopausal women, does administration of Estradot 50mcg patches twice weekly and/or Andro-Feme cream, 1/2ml daily, for eight weeks, compared to placebo improve dry eye clinical indices and biomarkers

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000281897

Enrollment

Registered

2012-03-09

Start date

2012-05-01

Completion date

Unknown

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

This project will investigate the effect of restoration of transdermal Testosterone and Oestrogen on dry eye clinical indicators and biomarkers in post menopausal women. Association between these sex hormones levels and the measured parameters might be elucidated while suggesting for an option of dry eye treatment in this population.

Interventions

Arm 1: Andro-Feme (Testosterone) cream, 1/2ml daily for 8 weeks Arm 2: Estradot (Oestradiol) 50mcg patches twice weekly for 8 weeks Arm 3: Combination of Anro-Feme and Estradot (as above)for 8 weeks Arm 4: Placebo patch and cream for 8 weeks

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Post menopausal women who has permanent cessation of menses for at least one year with dry eye

Exclusion criteria

Experience normal menstrual cycle History of corneal or refractive surgery Diagnosis of Sjogren’s Syndrome History of hormone therapy within the past 12 months Prior diagnosis of infectious disease transmittable by blood (eg HIV/AIDS, Hepatitis) Eye surgery within 6 months immediately prior to enrolment for this study

Outcome results